Documented incurable cancer with one of the following histologies: non-small cell lung cancer, malignant melanoma, renal cell cancer, triple negative breast cancer, colorectal cancer with microsatellite instability (MSI), bladder cancer, and metastatic castration resistant prostate cancer.
Phase b: Histologically and/or cytologically confirmed metastatic selected solid tumor types that have progressed after treatment with approved therapies or for which there are no standard effective therapies available. If nivolumab or pembrolizumab is an approved therapy for the participant's tumor type, but the participant has not been treated with it, the Investigator may enroll the participant in this study. Phase : Histologically and/or cytologically confirmed metastatic selected solid tumor types with - prior lines of systemic therapy (unless discussed with the sponsor) For the non-small cell lung cancer (NSCLC) and melanoma cohorts, participants must have progressed on or after prior treatment with one anti-PD-, anti-PD-L, or anti-PDL agent Selected tumor types of both phases: NSCLC, predominantly clear cell renal cell carcinoma, endometrial carcinoma, urothelial carcinoma, squamous cell carcinoma of the head and neck, or melanoma (excluding uveal melanoma)
Patient has one of the following histologically or cytologically confirmed advanced malignancies: acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), glioblastoma multiforme (GBM), melanoma, non-small cell lung cancer (NSCLC), ovarian cancer, pancreatic cancer, sarcoma, renal cell carcinoma (RCC)
Histologically confirmed diagnosis of a locally advanced (not amenable to curative therapy such as surgical resection) metastatic cancer of the following histologies: melanoma (MEL), Merkel cell carcinoma (MCC), triple-negative breast cancer (TNBC), ovarian carcinoma, renal cell carcinoma (RCC), colorectal cancer, urothelial carcinoma, or sarcoma.
In dose expansion (part ), patients must have histologically or cytologically confirmed unresectable or metastatic melanoma, renal cell carcinoma, ovarian cancer, or colorectal cancer
Dose Escalation Cohort: must have breast cancer, colorectal cancer, adrenocortical carcinoma, chromophobe renal cell carcinoma.
PART II: participants must have histologically confirmed advanced squamous cell lung cancer, advanced pancreatic cancer, advanced head & neck cancer (specifically non-oropharynx squamous cell carcinoma or human papillomavirus [HPV]-negative oropharynx squamous cell carcinoma), or any tumor with suspected PIK-pathway dependence (either by mutation or by known biologic rationale, such as endometrial cancer; PIK dependence includes the presence of a PIKCA-mutant hotspot mutation (such as E [K], E [A, G, or K], H [L, R, Y]), PIKCA copy number gain, or PTEN loss in the archival or fresh tumor tissue specimen identified in a Clinical Laboratory Improvement Act (CLIA)-certified laboratory; all genetic findings must be reviewed by the study principal investigator (PI), prior to study entry
Participants must have histologically or cytologically confirmed disease from melanoma, triple negative breast cancer, head and neck cancer, lung cancer, bladder cancer, renal cell cancer
Participants must have any of the following tumor types, confirmed by available pathology records or current biopsy, that is advanced, nonresectable, or recurrent and progressing since last antitumor therapy, and for which no alternative standard therapy exists: pancreatic adenocarcinoma, renal clear cell carcinoma, SCCHN (squamous cell carcinoma of head and neck), NSCLC (non-small cell lung cancer), colorectal cancer (CRC), hepatocellular carcinoma (HCC), ovarian serous epithelial cancer, bladder transitional cancer, cervical cancer, and triple-negative breast cancer
Subjects with the following solid tumors are eligible for screening: Non-small cell lung cancer (NSCLC), Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC), melanoma, bladder, Triple-negative breast cancer (TNBC), and Colorectal carcinoma displaying microsatellite instability (MSI CRC).
Eligible disease sites include the following\r\n* Breast\r\n* Prostate\r\n* Gastrointestinal (GI) (including colorectal, anal, esophagus, pancreas, gastric with the exception of patients with colon cancer and liver-only metastatic disease)\r\n* Head and neck\r\n* Skin (melanoma and squamous cell carcinoma)\r\n* Lung (both small cell and non-small cell)\r\n* Sarcoma (both soft tissue and bone)\r\n* Gynecologic (endometrial, cervical, ovarian, vaginal, vulvar)
Eligible disease sites include the following\r\n* Breast\r\n* Prostate\r\n* Gastrointestinal (GI) (including colorectal, anal, esophagus, pancreas, gastric with the exception of colon cancer with resectable liver-only lesions)\r\n* Head and neck\r\n* Skin (melanoma and squamous cell carcinoma)\r\n* Lung (both small cell and non-small cell)\r\n* Sarcoma (both soft tissue and bone)\r\n* Gynecologic (endometrial, cervical, ovarian, vaginal, vulvar)
Patient with Colorectal cancer, epithelial ovarian cell or fallopian tube carcinoma, urothelial carcinoma, Triple Negative Breast cancer, pancreatic cancer, AML/MDS or Multiple Myeloma
Patients with incurable malignancies with >= % -year cancer-associated mortality (as estimated by two physician and where appropriate according to  NCDB data); diseases include, but are not limited to:\r\n* Ampullary carcinoma\r\n* Appendiceal cancer\r\n* Colorectal cancer (CRC)\r\n* Extrahepatic cholangiocarcinoma (EHCC)\r\n* Esophageal adenocarcinoma\r\n* Gallbladder cancer (GBCA)\r\n* Gastric adenocarcinoma\r\n* Head and neck cancer\r\n* Hepatocellular carcinoma (HCC)\r\n* Intrahepatic cholangiocarcinoma (IHCC)\r\n* Melanoma\r\n* Non-KIT GIST (gastrointestinal stromal tumor)\r\n* Non-small cell lung cancer (NSCLC)\r\n* Ovarian cancer\r\n* Pancreatic ductal adenocarcinoma (PDAC)\r\n* Sarcoma (high-grade)\r\n* Small bowel adenocarcinoma (including duodenal)\r\n* Triple-negative breast cancer (TNBC)\r\n* Urothelial cancer\r\n** Note: we will limit gastrointestinal malignancies to no more than % of the case mix
Expansion cohort B, groups , , , , ,  and : Patients must have advanced pathologically proven mutant KRAS non-small cell lung cancer (group ), pancreatic cancer (group ; documentation of KRAS mutation not required), mutant KRAS colorectal cancer (group ), head and neck squamous cell carcinoma (group ), mesothelioma (group ), hepatocellular cancer (group ), and biliary carcinoma (group )
Measurable solid cancer with at least one lesion that is resectable for tumor infiltrating lymphocytes (TIL) generation with minimal morbidity plus at least one other lesion that can be measured that falls into one of four cohorts:\r\n* Gastrointestinal and genitourinary cancers\r\n* Breast and ovarian, and other solid cancers\r\n* Lung cancer (Non-small cell lung cancer ([NSCLC])\r\n* Glioblastoma\r\n** Note: Metastatic disease is required for cohorts -, but not required for cohort \r\n** Note: NSCLC includes but is not limited to squamous cell carcinoma, adenosquamous carcinoma or adenocarcinomas; neuroendocrine tumors are not eligible
Subject has histologically confirmed diagnosis of any one of the following cancers: urothelial cancer (transitional cell cancer of the bladder, ureter, urethra or renal pelvis), melanoma, squamous cell carcinoma of the head and neck, ovarian cancer, NSCLC (squamous, adenosquamous, or large cell), esophageal (squamous and adenocarcinoma) or gastric cancer, synovial sarcoma or MRCLS.
Has a histological confirmation of pancreatic cancer, mismatch deficient colorectal cancer, or non-small cell lung cancer (NSCLC) that is refractory to standard therapy or for which no standard of care regimen currently exists
Histologic diagnosis of solid malignant tumor including but not limited to non-small cell lung cancer, breast, prostate, renal cell, melanoma, gastrointestinal, sarcoma, thyroid, head and neck primary, and unknown primary tumors
Patient has histologically confirmed () colorectal cancer, triple negative breast cancer, pancreatic cancer, non-small cell lung cancer, head and neck cancer, ovarian cancer, lymphoma, sarcoma, bladder cancer, or melanoma with defects in one or more of the following genes: ABL, ACVRB, APC, ASXL, ATM, ATR, BLM, BRCA, BRCA, CDK, CDKNA, CDKNB, CDKNA, CHD, CYLD, DICER, DNMTA, ERBB, EZH, FGFR, FLT, GATA, HGF, KDMA, KDR, KEAP, KIT, KMTD, KRAS, MAGI, MAPK, MED, MET, MSH-, MSH-, MYC, NA, NF, NF, NOTCH, NOTCH, NRAS, NSD, PIKCB, PIKCA, PIKCB, PIKR, PTCH, PTPN, RB, RUNX, SETD, SMARCA, SOX, STAG, TAF, TBX, TET, TP, XPO; () documented IDH mutated solid tumor (other than glioma); or () documented IDH mutated or MGMT promoter methylation positive glioblastoma multiforme (GBM) or anaplastic astrocytoma. Note: Genetic abnormalities must be documented by Foundation Medicine (or equivalent) genomic profile report.
For subjects in the every  week and every  week dosing cohorts histologically or cytologically documented diagnosis of urothelial carcinoma, melanoma, squamous cell carcinoma of the head and neck, non-small cell lung cancer, or any solid tumor with high microsatellite instability status (MSI-high)
Part b: Subjects with endometrial cancer, gastric cancer, head and neck squamous cell carcinoma, melanoma, microsatellite unstable colorectal cancer, non-small cell lung cancer, pancreatic ductal adenocarcinoma, renal cell carcinoma, triple negative breast cancer, or transitional cell carcinoma of the genitourinary tract that have had disease progression after available therapies for metastatic disease that are known to confer clinical benefit, been intolerant to treatment, or refused standard treatment.
Histologically confirmed diagnosis of one of the following cancers: melanoma (including mucosal and/or ocular), bladder/urothelial, non-small cell lung cancer, pancreatic adenocarcinoma, breast, colorectal, gastric, esophageal, renal cell, hepatic, ovarian, head and neck, and cholangiocarcinoma
There is reasonable expectation of response to pembrolizumab or nivolumab, and one of the drugs is available from the commercial supply; this includes (but is not limited to) the following tumor types: melanoma, non-small cell lung cancer, renal cell carcinoma, squamous cell carcinoma of the head and neck, bladder cancer, and classic Hodgkin lymphoma
Patient must have diagnosis of lung cancer, breast cancer, colorectal cancer, cholangiocarcinoma, gastric cancer, pancreatic cancer, prostate cancer, uterine cancer, ovarian cancer, esophageal cancer, or head and neck cancer
Patients with the following histologies are not eligible for either study cohort:\r\n* Non-small cell lung cancer, squamous cell carcinoma of head and neck, melanoma, renal cell carcinoma, bladder cancer, Hodgkins lymphoma, Merkel cell carcinoma, and MSI-H colorectal cancer
Since p mutations occur in a wide variety of tumor types, this is a mixed histology study for incurable tumors; subjects with the following solid tumors are eligible for screening: non-small cell lung cancer, squamous cell carcinoma of the head and neck, hepatocellular carcinoma, renal cell carcinoma, melanoma, bladder, soft tissue sarcoma, triple-negative breast cancer, and colorectal carcinoma displaying microsatellite instability and pancreatic cancer
Histologically-diagnosed advanced (unresectable and/or metastatic) Non-small Cell Lung Cancer (Phase l only), Melanoma (Phase l only), Colorectal, Head and Neck SCC (squamous cell carcinoma), Ovarian Cancer, Glioblastoma or Renal Cell Carcinoma.
Portion A: Histological or cytological diagnosis of advanced/metastatic solid tumor malignancy or B cell lymphoma, for which no curative therapy is available. Portion A expansion includes patients who have documented disease progression on a checkpoint inhibitor (anti CTLA , anti PD/PD L antibodies) per RECIST criteria. Tumor types include metastatic melanoma, renal cell carcinoma (RCC), non-small cell lung cancer (NCSLC) and squamous cell carcinoma of the head and neck (SCCHN). Patients in the dose expansion stage are required to provide archival or baseline (obtained during the screening period) tumor biopsies.
Subjects with histologically or cytologically NSCLC, melanoma, transitional cell carcinoma of the genitourinary (GU) tract, renal cell cancer, triple negative breast cancer, adenocarcinoma of the endometrium or squamous cell carcinoma of the head and neck (Phase ).
Subjects with histologically confirmed melanoma, NSCLC, transitional cell carcinoma of the GU tract, TNBC, SCCHN, ovarian cancer, MSI high colorectal cancer (CRC), RCC, gastric cancer, HCC and DLBCL (Phase ).
Histologically or cytologically confirmed carcinoma (prostate cancer, renal cell carcinoma, head and neck cancer, triple-negative breast cancer, bladder cancer, non-small cell lung cancer) or melanoma that overexpresses B-H.
Inclusion Criteria:\n\n        Part A Escalation Cohorts:\n\n        o Histologically or cytologically confirmed advanced malignant solid tumor, limited to\n        melanoma, castrate resistant prostate cancer (CRPC), ovarian cancer (OVCA), renal cell\n        carcinoma, colorectal carcinoma (CRC), pancreatic carcinoma or non-small cell lung\n        carcinoma (NSCLC) that is refractory to, intolerant of, for which no standard of therapy is\n        available or where the patient refuses existing therapies\n\n        Part A Expansion Cohorts, Part B and C Escalation and Expansion Cohorts:\n\n          -  Tumors with all histological diagnosis or tissue origin may be enrolled\n\n          -  Patients must have failed prior standard curative chemotherapy for their disease,\n             refuse existing therapies OR the proposed chemotherapy regimen to which AM is\n             added represents an acceptable standard treatment for their disease.\n\n               -  Measurable or evaluable disease according to irRC or bone metastatic disease\n                  evaluable by Prostate Cancer Working Group  criteria (PCWG) for\n                  castration-resistant prostate cancer (CRPC)\n\n               -  At least  years of age\n\n               -  Performance Status of  or \n\n               -  Adequate organ function\n\n        Exclusion Criteria:\n\n          -  Hematologic malignancies\n\n          -  Pregnant or lactating\n\n          -  Present or history of neurological disorders such as Multiple Sclerosis and Guillain\n             Barre or inflammatory central nervous system/peripheral nervous system (CNS/PNS)\n             disorders\n\n          -  Myocardial infarction within the last  months\n\n          -  Unstable angina, or unstable cardiac arrhythmia requiring medication\n\n          -  Surgery within the last  days\n\n          -  Systemic fungal, bacterial, viral, or other infection\n\n          -  History of bleeding diathesis within the last  months\n\n          -  Positive for human immunodeficiency virus (HIV), hepatitis C, or hepatitis B
SUB-PROTOCOL AIM A: Histological confirmation of renal cell carcinoma, head and neck cancer, endometrial cancer, breast cancer, ovarian cancer, prostate cancer, squamous cell cervical or uterine cancer, or bladder cancer
Must have pancreatic, ovarian, gastric, non-small cell cancer or mesothelioma. For dose expansion, must have tumor that is positive for mesothelin
Cohort B: Histologically confirmed metastatic solid tumor of epithelial origin, excluding non-small cell lung carcinoma (NSCLC), including but not limited to ovarian cancer, colorectal cancer, pancreatic cancer, gastric cancer, renal cancer, bladder cancer, or breast cancer with radiographic evidence by MRI of at least one measurable brain lesion as defined by RANO criteria that does not require corticosteroids for symptomatic control
For the expansion stage, histologically confirmed renal cell cancer (RCC), urothelial bladder cancer (UBC), triple-negative breast cancer (TNBC), non-small cell lung cancer (NSCLC), melanoma, head and neck squamous cell carcinoma (HNSCC), gastric cancer, ovarian cancer, cervical cancer, endometrial cancer, or Merkel cell cancer
For Phase B: histology specified below i. NSCLC (subjects with documented EGFR mutation or ALK rearrangement should be excluded) ii. ovarian cancer iii. gastric cancer iv. HCC (Barcelona-Clinic Liver Cancer stage C, stage B not amenable to locoregional therapy or refractory to locoregional therapy, and not amenable to a curative treatment approach, and Child-Pugh A) v. HNSCC vi. esophageal carcinoma vii. TNBC viii. cholangiocarcinoma ix. RCC, bladder cancer, melanoma, Merkel-cell carcinoma, sarcoma, GIST, or cuSCC. Or any other solid tumors with known MSI-H or dMMR status, such as CRC or pancreatic cancer
Histologically proven advanced or metastatic solid cancer for which bevacizumab has an indication: renal cell carcinoma, colorectal adenocarcinoma, non-squamous non-small cell lung cancer, platinum-refractory ovarian carcinoma, cervical carcinoma.
Histologically or cytologically confirmed metastatic solid tumor, including but not limited to pancreatic adenocarcinoma, breast cancer, melanoma, renal cell carcinoma (RCC), colorectal adenocarcinoma, non-small cell lung cancer, and others approved by the principal investigator
Diagnosis of advanced solid tumors limited to: melanoma, kidney cancer, lung cancer, colorectal carcinoma, prostate cancer, and neuroendocrine tumor progressing on standard therapy.
Prior systemic chemotherapy, immunotherapy (including interferon), or biological therapy, radiation therapy and/or surgery for resection of solid tumor (limited to: melanoma, kidney cancer, lung cancer, colorectal carcinoma, prostate cancer, and neuroendocrine tumor) are allowed.
Unresectable recurrent or metastatic head and neck cancer (HNC) (non-squamous cell cancer allowed), renal cell cancer (RCC) (non-clear cell types allowed), melanoma and lung cancer and candidates for RT
Histologically- or cytologically-confirmed ovarian cancer, colorectal cancer, non-triple negative breast cancer, renal cell carcinoma and cervical cancer, with at least one lesion measurable by irRC not previously irradiated.
Histological confirmation of malignancy (non-small cell lung cancer, breast cancer [hormone refractory], prostate cancer [hormone refractory], lymphoma, renal cell carcinoma, myeloma) by either biopsy or cytology of the primary or metastatic lesion
Pathologically confirmed diagnosis of cancer, including, but not limited to non-small cell lung cancer, breast, prostate, renal cell, melanoma, gastrointestinal, sarcoma, thyroid, head and neck primary, and carcinoma of unknown primary
Patients must have histologically documented metastatic or unresectable non-small cell lung cancer, head and neck cancer, urothelial transitional cell carcinoma, or breast cancer whose disease has progressed after at least one line of standard therapy
Phase l: Melanoma, RCC, triple negative breast cancer, bladder cancer, head and neck cancer or non-small cell lung cancer.
Has a solid tumor likely to exhibit elevated levels of EGFR (e.g. head and neck squamous cell carcinoma, non-small cell lung cancer, triple negative breast cancer ,colorectal carcinoma and glioblastoma multiforme).
Participants in the Dose Escalation portion must have one of the following advanced or recurrent malignancies: gastrointestinal (colorectal or gastric); ovarian; melanoma; non-small cell lung adenocarcinoma; or bladder.
DOSE ESCALATION COHORT ONLY: Adult patients with histologic documentation of an advanced solid tumor for whom gemcitabine and carboplatin would be appropriate first line therapy, including but not limited to urothelial cancer, non-small cell lung cancer, pancreatic and ovarian carcinoma
For Part b: Subjects with histologically or cytologically confirmed advanced or metastatic endometrial cancer, gastric cancer, melanoma, microsatellite unstable (MSI) colorectal cancer or other MMR-deficient tumors, non-small cell lung cancer, renal cell carcinoma, head and neck squamous cell carcinoma, triple negative breast cancer, pancreatic ductal carcinoma, or transitional cell carcinoma of the genitourinary tract that have had disease progression after available therapies for advanced or metastatic disease that are known to confer clinical benefit, been intolerant to treatment, or refused standard treatment.
Histologically confirmed diagnosis of locally advanced, recurrent, and/or metastatic triple-negative breast cancer, ovarian cancer, gastric cancer, colorectal cancer, pancreatic cancer, melanoma, or mesothelioma
For dose escalation portion of the study: Patients must have a histologically or cytologically confirmed metastatic solid tumor that has shown clinical or pre-clinical evidence of responding to anti-PD- therapy or the capacity to up-regulate PD-L; these tumor types may include but may not be limited to: renal cell carcinoma (RCC), urothelial carcinoma (UC), melanoma, non-small cell lung cancer (NSCLC), small cell lung cancer, squamous cell cancer of the head and neck (SCCHN), ovarian carcinoma, triple negative breast cancer, gastric cancer, microsatellite instability expressing (MSI-high) colon cancer, hepatocellular carcinoma, mesothelioma, gastrointestinal stromal tumors, endometrial carcinoma, liposarcomas, chondrosarcomas, and uterine sarcomas; patients with solid tumor types not listed above may be enrolled at the discretion of the principal investigator
Pathologically confirmed: Non-small cell lung cancer (NSCLC, adenocarcinoma or squamous-cell carcinoma), Breast Cancer (HER positive or triple negative), Pancreatic Cancer (adenocarcinoma)
Additionally, for patients who are considered for enrollment into the indication specific expansion cohorts in Stage , the current cancer must be either KRAS-mutant colorectal cancer (CRC) or KRAS-mutant non-small cell lung cancer (NSCLC)
Histologically or cytologically confirmed diagnosis of one of the following solid tumor malignancies for which no standard therapeutic alternatives exist: bladder cancer, breast cancer, castrate-resistant prostate cancer, cervical cancer, colorectal cancer (CRC), gastric cancer, hepatocellular carcinoma (HCC), melanoma, non-small cell lung cancer (NSCLC), ovarian cancer, pancreatic cancer, squamous cancers of the head and neck region (including parotid and nasopharynx).
Subjects with squamous non-small cell lung cancer and triple-negative breast cancer or other solid tumor types for which Notch activation has been demonstrated (such as pancreatic, ovarian and melanoma) during dose expansion
Patients must have known HIV infection and histologically confirmed solid malignancy that is metastatic or unresectable and is therefore incurable; although the focus of this trial will be on upper aerodigestive cancers (non-small cell lung cancer, head and neck squamous cell carcinoma, and non-gastroesophageal junction esophageal cancer), patients with other incurable solid tumor with disease potentially sensitive to carboplatin and/or taxanes (including but not limited to salivary gland cancer, gastric cancer, breast cancer, ovarian cancer, or anal cancer, BUT excluding Kaposi sarcoma), will be eligible
Histologically or cytologically confirmed non-small cell lung cancer or other platinum responsive malignancies, including but not limited to: esophageal cancer, ovarian cancer, germ cell malignancies, transitional cell cancer, that are not curable with chemotherapy, surgery or radiotherapy; a tissue block,  unstained slides or fresh tissue biopsy is required; patients with central nervous system (CNS) metastases which are symptomatic must have received therapy (surgery, XRT, gamma knife) and be neurologically stable and off steroids; patients with asymptomatic lesions without significant edema and no evidence of shift are allowed to participate without prior CNS therapy; such patients are anticipated to receive specific CNS therapy after - courses of study therapy
Subjects must have melanoma or lung cancer or renal cell carcinoma and received ipilimumab or nivolumab as a single treatment or in combination
Any advanced solid malignancy will be eligible, with a strong preference for tumors that are known to commonly harbor defects in homologous recombination repair including triple-negative breast cancer, high-grade serous ovarian cancer, non-small cell lung cancer, small cell lung cancer, mesothelioma castration-resistant prostate cancer, pancreatic adenocarcinoma, gastric cancer and head & neck squamous cell cancer
Histological or cytological documentation of an invasive malignancy that was diagnosed as locally advanced/metastatic or relapsed/refractory and is of one of the following tumor types:: bladder; cervical; colorectal (includes appendix); esophagus, squamous cell; head and neck; melanoma; malignant pleural mesothelioma (MPM); non-small-cell lung cancer (NSCLC), prostate; Microsatellite Instability-High/deficient mismatch repair (MSI-H/dMMR) tumor (Part B and Part B) and Human Papilloma Virus (HPV)-positive or Epstein-Barr (EBV)-positive tumor (Part B and Part B.
PHASE : PATIENT EXCLUSION CRITERIA: Patients with cancer diagnoses that are not typically considered pediatric cancer, including basal and squamous cell skin cancer, breast, colorectal, lung, melanoma, merkel cell skin cancer, ovarian, testicular, kidney cancer diagnosed at age > , and nasopharyngeal diagnosed at age > 
PHASE A/B: PATIENT EXCLUSION CRITERIA: Patients with cancer diagnoses that are not typically considered pediatric cancer, including basal and squamous cell skin cancer, breast, colorectal, lung, melanoma, merkel cell skin cancer, ovarian, testicular, kidney cancer diagnosed at age > , and nasopharyngeal diagnosed at age > 
Participants must have histologically confirmed diagnosis of locally advanced and/or metastatic triple negative breast cancer, ovarian cancer, bladder cancer, gastric cancer, or soft tissue sarcoma, with exceptions defined in the exclusion criteria
Prior germ cell cancer
Patients must have histologically or cytologically confirmed (at original diagnosis or subsequent recurrence or progression) lymphoma, chronic lymphocytic lymphoma (CLL) or solid tumor; patients with lymphoma or CLL must have radiologically or clinically evaluable disease, and be refractory to standard therapy as defined by relapse within  months of last treatment (see note below); patients with solid tumors must have radiologically or clinically evaluable disease that is metastatic, unresectable, progressive, or recurrent, and for which standard curative measures do not exist or are no longer effective\r\n* Patients with a liver mass, raised alpha-fetoprotein level (>=  ng/mL) and positive serology for hepatitis, consistent with a diagnosis of hepatocellular carcinoma will be eligible without the need for pathologic confirmation of the diagnosis\r\n* Patients with prostate cancer, renal cell cancer, neuroendocrine tumors, lung cancer, colorectal cancers, soft tissue sarcomas, glioma and thyroid cancer are excluded in the normal and mild cohorts due to a lack of efficacy in these tumor types in phase  studies; patients with breast, pancreatic, bladder, head and neck cancers, as well as melanoma and other malignancies are eligible\r\n* Note: patients with prostate cancer, renal cell cancer, lung cancer, colorectal cancers, soft tissue sarcomas, glioma and thyroid cancer are allowed to enroll in the moderate and severe cohorts provided the patients:\r\n** Sign a separate consent form which outlines the lack of efficacy observed in prior studies\r\n** Are consented to the study by a protocol-specified designee who is not their longitudinal oncologist; patients with neuroendocrine tumors are still excluded from the moderate and severe cohorts\r\n* Note: as romidepsin is approved for patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) or cutaneous T cell lymphoma (CTCL), these patients would be eligible WITHOUT the requirement of having relapsed within  months of last treatment
Patients with prostate cancer, renal cell cancer, neuroendocrine tumors, lung cancer, colorectal cancers, soft tissue sarcomas, glioma, and thyroid cancer are excluded in the normal and mild cohorts due to a lack of efficacy in these tumor types in phase  studies; patients with prostate cancer, renal cell cancer, lung cancer, colorectal cancers, soft tissue sarcomas, glioma and thyroid cancer are allowed to enroll in the moderate and severe cohorts only; patients with neuroendocrine tumors are still excluded from the moderate and severe cohorts
Unresectable advanced or metastatic ACC, non-urothelial bladder/upper tract cancer, non-adenocarcinoma prostate cancer, penile cancer or treatment refractory germ-cell tumor
Dosimetry Studies Arm (Completed July ): \r\n* Healthy volunteer OR participant with biopsy-proven diagnosis of head and neck squamous cell carcinoma (HNSCC), any histopathologic type of lung cancer, or any other type of cancer that can be treated with platinum-based chemotherapy (which includes but is not limited to ovarian, lung, gastric, hepatic, and pancreatic cancers)
Inclusion Criteria:\n\n        Cisplatin Combination Expansion:\n\n        Arm :Patients with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic\n        setting; Arm : Patients with TNBC and one or two prior cytotoxic therapies in the\n        metastatic setting.\n\n          -  Arm A: castrate resistant prostate cancer, advanced breast cancer, or non-small cell\n             lunch cancer that are candidates for treatment with a docetaxel-based combination.\n\n          -  Arm B: Urothelial transitional cell cancer, triple negative breast cancer, ovarian\n             cancer or non small cell lunch cancer that are candidates for a cisplatin-based\n             combination.\n\n          -  Arm C: Her+ breast cancer refractory to prior herceptin or lapatinib, her+\n             esophagal-gastric cancer, head and neck squamous cell cancer, or non small cell lunch\n             cancer that are candidates for treatment with a dacomitinib-based combination.\n\n          -  Availability of archival tumor biopsy sample or willing to provide fresh biopsy if not\n             available.\n\n          -  Eastern Cooperative Oncology Group [ECOG] performance must be  or .\n\n          -  Adequate bone marrow, renal and liver function.\n\n        Exclusion Criteria:\n\n          -  Prior therapy for Cisplatin Combination Expansion:\n\n               -  Prior platinum (carboplatin or cisplatin) in either the adjuvant or metastatic\n                  setting;\n\n               -  Prior radiation to >% bone marrow as estimated by the Investigator.\n\n          -  Patients with known symptomatic brain metastases.\n\n          -  Chemotherapy, radiotherapy, biologics or investigational agent within  weeks of the\n             lead-in dose.\n\n          -  Major surgery within  weeks of the baseline disease assessments.\n\n          -  > prior regimens containing cytotoxic chemotherapy in the metastatic setting.\n\n          -  Active bacterial, fungal or viral infection.\n\n          -  Uncontrolled or significant cardiovascular disease.
Focus on one of the following disease categories: non-small cell lung cancer, colon cancer, breast cancer, prostate cancer, kidney cancer, lymphoma
Histologically or cytologically confirmed measurable advanced and/or metastatic solid GI tumor that expresses GCC protein (H-score greater than [>] ), for which standard treatment is no longer effective or does not offer curative or life-prolonging benefit. For the escalation part of the study (Part A), GI malignancies include, but are not limited to, metastatic colorectal carcinoma (mCRC), gastric carcinoma, esophageal carcinoma, small intestine cancer, and pancreatic cancer. The expansion part of the study (Part B) is limited to participants with CRC.
Part : Subjects with advanced or metastatic adenocarcinoma of the endometrium, ovarian cancer, renal cell carcinoma, melanoma, and non-small cell lung cancer.