HER positive breast cancer or gastric cancer that is resistant to standard therapy or for which no standard therapy is available
PART I: participants must have histologically confirmed malignancy that is metastatic or unresectable and resistant to standard therapy or for which no standard therapy is available
Participants in combination therapy cohorts must have an advanced solid tumor where the use of nivolumab is standard therapy.
Histologic documentation of locally advanced, recurrent, or metastatic incurable malignancy that has progressed after at least one available standard therapy; or for which standard therapy has proven ineffective, intolerable, or considered inappropriate; or for which a clinical trial of an investigational agent is a recognized standard of care
Diagnosis of tumor type with the potential to have P-cadherin expression that is resistant to standard therapy or for which no standard therapy is available
Histological documentation of locally advanced, recurrent or metastatic solid malignancy that has progressed after standard therapy appropriate for the specific tumor type, or for which standard therapy has proven to be ineffective, intolerable, or is considered inappropriate. Subjects should not have received more than prior lines of therapy for advanced disease including both standards of care and investigational therapies. Subjects whose cancers harbor molecular alterations for which targeted therapy is standard of care should have received health authority approved appropriate targeted therapy for their tumor types before enrollment.
Histologic evidence of advanced solid tumors (excluding central nervous system (CNS) primary tumors) non-resectable, refractory to standard therapies, or patient cannot receive or refuses standard therapy.
Progression after standard systemic therapy or a lack of available effective therapy, in the assessment of the Investigator.
Progression after standard systemic therapy or a lack of available effective therapy, in the assessment of the Investigator.
Standard treatment is not available
Malignancies for which there is no standard therapy, or previously treated locally advanced, refractory/relapsed or metastatic disease for which local curative surgery, curable radiotherapy, or satisfactory systemic anticancer therapy is no longer available
Phase a: histological or cytological confirmation of a solid, malignant tumor, excluding CNS tumors, that is refractory to standard therapies or for which no standard therapies exist.
The patient must have histologic or cytologic evidence of a malignant solid tumor and must have disease that is resistant to or relapsed following available standard systemic therapy, or for which there is no standard systemic therapy or reasonable therapy likely to result in clinical benefit.
Patient must have an advanced (metastatic or recurrent) pathologically proven solid tumor which has not responded to standard therapy or which has progressed following standard therapy for advanced disease and/or for which no standard therapy is known to be effective; patients in expansion cohort A must have accessible tumor for biopsy
Locally advanced, recurrent, or metastatic incurable malignancy that has progressed after at least one available standard therapy; or for whom standard therapy has proven to be ineffective or intolerable, or is considered inappropriate; or for whom a clinical trial of an investigational agent is a recognized standard of care; or for whom a clinical trial of an investigational agent is considered an acceptable treatment option
Patients must have a diagnosis of a solid tumor malignancy and is refractory to standard therapies who have relapsed after standard therapy, or whose cancers have no standard therapy.
Has relapsed from or is refractory to standard treatment or for which no standard treatment is available
All patients must be refractory to approved standard systemic therapy
For the Western safety cohort only: participants with locally advanced or metastatic solid tumor for whom no standard treatment with an established survival benefit is available or if the participant refuses other standard therapy.
Patients with advanced cancer that is refractory to standard therapy, or that has either relapsed after standard therapy or has no standard therapy that increases survival by at least three months
Patients with advanced solid tumors that are refractory to approved therapy and have had at least one line of systemic treatment with chemotherapy, immunotherapy, hormonal therapy, or other standard treatments for metastatic disease
Patients must have a diagnosis of advanced or metastatic malignancy that is refractory to standard therapies, who have relapsed after standard therapy, or whose cancers have no standard therapy that induces a complete response (CR) rate of at least % or improves survival by at least three months
Patients with advanced or metastatic cancer that is refractory to standard therapy or that has relapsed after standard therapy or has no standard therapy that increases survival by at least three months
Recurrent or refractory disease for which no further effective standard treatment is available
PHASE I: Patients must have advanced solid tumor that is resistant or refractory to standard therapy
Patient has an advanced malignancy that has progressed or recurred following standard therapy for advanced disease, and for which no curative therapies are available.
Patients for whom there is no further standard therapy available at the time of enrollment (Part A)
ELIGIBILITY CRITERIA- LYMPHODEPLETION/INFUSION OF tvs-CTL: Recurrent, refractory or relapsed advanced stage melanoma defined as progression of disease through standard therapy or patient choice to not receive standard therapy; for those that received standard systemic therapy, treatment agents may have included (but are not limited to) ipilimumab or vemurafenib (for those patients that are BRAF ve positive)
Patients with an advanced solid tumor that is refractory to standard treatment, or for which no standard therapy is available, or the subject refuses standard therapy
Patients must have pathologically-confirmed solid tumors, refractory after standard therapy for the disease or for which conventional systemic chemotherapy is not reliably effective or no effective therapy is available.
Have histologic or cytological proof of advanced cancer that has progressed and for which there is no further standard anticancer therapy available in the opinion of the investigator.
Patients with advanced or metastatic cancer that is refractory to standard therapy, relapsed after standard therapy, or who have no standard therapy available that improves survival by at least three months
Patients with advanced or metastatic cancer that is refractory to standard therapy, relapsed after standard therapy, or have no standard therapy that induces a complete response of at least % or improves survival by at least three months; in addition, patients with disease that are benign by pathology, but relentlessly progressive, leading to disability, pain, and premature death in the majority of cases (including, but not limited to lymphangioleiomyomatosis [LAM], type neurofibromatosis [NF], Erdheim Chester disease, and Castlemans disease) may also be considered for enrollment
Patients with advanced or metastatic cancers and BRAF mutations that are refractory to standard therapy, relapsed after standard therapy, or who have no standard therapy available that improves survival by at least three months; patients with BRAF mutation in cell free deoxyribonucleic acid (DNA) (tested in Clinical Laboratory Improvement Amendments [CLIA] lab) are also eligible
Patients with advanced or metastatic cancer that is refractory to standard therapies, who have relapsed after standard therapy, or whose cancers have no standard therapy that induces a complete response (CR) rate of at least % or improves survival by at least three months
Unresponsive to currently available therapy and there is no standard-of-care therapy available in the judgment of the investigator.
Unresectable, locally advanced or metastatic solid tumor for which no standard therapy is recognized or for which standard therapy has failed
Patients must have metastatic disease that is either refractory to standard therapy or for which no effective standard therapy that confers clinical benefit is available
Has disease that is refractory to or intolerable with standard treatment, or for which no standard treatment is available
Patient with documented pathological evidence of a cancer from which has developed advanced unresectable solid tumors that are, in the opinion of their treating physician, refractory to standard therapy or for which no standard therapy is available
Subjects must have a pathologically documented, definitively diagnosed, advanced solid tumor that is refractory to standard treatment, for which no standard therapy is available, or the subject refuses standard therapy
Patient has advanced or metastatic breast cancer that is refractory to at least one standard therapy or that has relapsed after standard therapy or that has no standard systemic therapy that increases survival by at least months.
Solid tumor malignancy for which no standard of care therapy is available which has a proven overall survival benefit
For the dose escalation part: Patients with selected, relapsed solid tumors who have failed available standard therapy or who are not candidates for standard therapy.
Patients must have relapsed after or be refractory to effective standard therapies; for NF PN there is no standard medical therapy, and therefore no requirement for prior therapy; there are no limits on number of prior therapeutic regimens
COHORT I (DOSE ESCALATION): histologic proof of cancer that is now unresectable, not amenable to any other standard therapies, or patient refuses standard therapy
Advanced (unresectable) solid tumors: patients must have failed or been intolerant to at least one line of standard therapy or refuse standard treatment
Advanced metastatic or unresectable malignancy that is refractory to standard therapy and/or existing therapies are not likely to achieve clinical benefit, and/or the patient declines to receive standard treatment such as chemotherapy.
Histologic documentation of locally advanced, recurrent or metastatic incurable solid malignancy that has progressed after all available standard therapy or for which standard therapy has proven to be ineffective or intolerable, or is considered inappropriate
Histologic documentation of locally advanced, recurrent, or metastatic incurable solid malignancy that has progressed after available standard therapy; or for which standard therapy is ineffective, intolerable, or considered inappropriate; or for which a clinical trial of an investigational agent is recognized standard of care
Pathologically documented, advanced colorectal, pancreatic or non-small cell lung cancer that is refractory to standard treatment, or the subjects have been intolerant to or refuse standard treatment.
Patients must have a histologically confirmed non-hematological malignancy established by biopsy or resection; patients must have received and failed standard treatment for their malignancy; patients for whom no standard treatment is available will also be eligible
Group : BRAFV positive metastatic colorectal carcinoma (CRC), or advanced non-small cell lung carcinoma (NSCLC) after failure of at least two lines of prior standard therapy or for whom no further standard therapy is indicated.
Subjects must have no standard therapy available, or have actively refused standard therapy
Progression following at least one standard therapy; or standard therapy considered ineffective, intolerable, or inappropriate; or use of an investigational agent recognized as a standard of care
Patients must have a diagnosis with solid tumors and lymphomas, either refractory to standard therapy or for which no effective standard therapy that conveys clinical benefit
Patients with relapsed, advanced and/or metastatic cancer who have failed available standard treatments or who are not candidates for standard therapy. Patients must have measurable disease
Patients with advanced or metastatic cancers that are refractory to standard therapy, relapsed after standard therapy, or who have no standard therapy available that improves survival by at least three months.
Subject has histologic or cytologic confirmation of advanced solid tumors that is refractory to standard therapy or for which no standard therapy is available
Have histological or cytological diagnosis of locally advanced/metastatic HER solid tumors that has progressed or become intolerant to standard therapy or for which no standard therapy is available
Dose Escalation Cohort only: Confirmed advanced solid tumor or lymphoma for which standard curative or palliative measures do not exist or are no longer effective; subjects with progressive brain metastases are also eligible. OR Confirmed Histological/cytological hematological malignancy that is refractory to/relapsed after and/or intolerant of standard therapies or for which no standard therapy exists. OR Confirmed high grade glioma (grade and) that is relapsed/refractory to standard therapies and who have progressive disease following radiation therapy. Patients with any number of prior treatments are allowed.
Had received standard treatment (no limitations for prior therapies), and in treating physicians opinion, no suitable standard treatment is available, or for those subjects who decline chemotherapy
Patients with advanced or metastatic cancer that is refractory to standard therapy or has relapsed after standard therapy
Patients with advanced or metastatic cancer that is refractory to standard therapy, relapsed after standard therapy, or have no standard therapy that induces a complete response (CR) rate of at least % or improves survival by at least three months
Refractory to standard therapy, relapsed after standard therapy, or have no standard therapy that increases survival at least months
Failed to respond to or relapsed following standard treatment, or declined or was not eligible for standard treatment.
Phase I patients: Histologic documentation of a solid malignancy and who have exhausted available standard medical treatments or for whom no standard treatments are currently available; this includes primary brain tumors
Patients with advanced or metastatic cancers with no available standard therapy are eligible to enter the phase portion of this study
Patients must have pathologically-confirmed acute leukemia, refractory or relapsed after standard therapy for the disease or for which conventional systemic chemotherapy is not reliably effective or no effective therapy is available Phase II Only: Patient must have histologically or pathologically confirmed diagnosis of AML based on WHO classification that is refractory after standard therapy, or for which conventional systemic chemotherapy is not reliably effective, or no effective therapy is available. Patients aged years or older with newly diagnosed AML who are not eligible for, or who refuse, standard care are also eligible.
Patient must have histologically or cytologically confirmed diagnosis of advanced solid tumor or lymphoma harboring a B-Raf proto-oncogene, serine/threonine kinase (BRAF) mutation, for which no standard therapy is available, is resistant/refractory to standard therapy, has relapsed after standard therapy, or has no standard therapy that improves survival by at least three months
Patients with advanced solid tumor that is refractory to standard treatment, for which no standard treatment is available, or the patient refuses standard therapy.
Patients with advanced cancer should be refractory to standard therapy, relapsed after standard therapy, or have no standard therapy available that improves survival by at least three months
Patients with advanced cancer, either refractory to standard therapy or for which no effective standard therapy that increases survival for at least months is available
Patients with advanced or metastatic cancers that are refractory to standard therapy, relapsed after standard therapy, or who have no standard therapy available that improves survival by at least three months
Patients with pathologically confirmed advanced or metastatic cancer that is refractory to standard therapy, relapsed after standard therapy, or who have had no standard therapy that induces a complete response (CR) rate of at least % or improves survival by at least three months
Patients with advanced or metastatic cancer that is refractory to standard therapy, relapsed after standard therapy, or have no standard therapy that induces a complete response (CR) rate of at least % or improves survival by at least three months
Patients with advanced or metastatic cancer that is refractory to standard therapy, relapsed after standard therapy, or have no standard therapy that induces a complete response (CR) rate of at least % or improves survival by at least three months
Solid tumors refractory to standard therapy
Histological or cytological diagnosis of advanced/metastatic solid tumor malignancy. Dose Finding Cohorts: Tumor types will be limited to CRC, SCCHN, squamous NSCLC, bladder, or ovarian carcinomas which have progressed on standard therapy, or for which no standard therapy is available.
Confirmed relapsed or refractory locally advanced or metastatic solid cancer for whom no standard therapy is considered appropriate, or for whom standard therapy is considered intolerable.
Subjects with advanced, histologically or cytologically confirmed tumor, refractory to any standard treatment, with no standard therapy available, in whom standard therapy is not a therapeutic option or the subject actively refuses use of chemotherapy which would be regarded standard and/or if in the judgment of the investigator, experimental treatment is clinically and ethically acceptable.
Diagnosis of solid tumor that is advanced/metastatic and resistant to standard therapy or for whom no standard therapy is available
Diagnosis of solid tumor that is advanced/metastatic and resistant to standard therapy or for which no standard therapy is available.
Male or female patient with Glypican positive advanced solid tumor not amenable to standard therapy or for which standard therapy is not available or not indicated
Advanced breast cancer with HER overexpression that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
Advanced breast cancer with HER low expression that is refractory to or intolerable with standard treatment, or for which no standard treatment is available. Part d:
Advanced/unresectable or metastatic tumor with HER mutation that is refractory to or intolerable with standard treatment, or for which no standard treatment is available. Part e:
Advanced breast cancer with HER overexpression that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
Part , Part b, Part d, and Part e: Patients with advanced solid tumors who have tumor progression following standard therapy, have treatment-refractory disease, or for whom there is no effective standard of therapy.
Patients with recurrent metastatic or locally advanced disease considered refractory or intolerant to all standard treatment available for their tumor, or those tumors for which no standard treatment is available
Advanced/metastatic solid tumor refractory to standard therapy
Pathologically-documented, definitively-diagnosed AML that is relapsed or refractory to standard treatment, for which no standard therapy is available or the subject refuses standard therapy
Patients with relapsed, advanced and/or metastatic cancer who have failed available standard treatments or who are not candidates for standard therapy. Patients must have measurable disease
Histological or cytological diagnosis of advanced/metastatic solid tumor malignancy which has progressed on standard therapy or for which no standard therapy is available.
Progression on standard therapies or withdrawn from standard treatment due to unacceptable toxicity. Previous standard treatment must include all of the following:
Diagnosis of advanced/metastatic solid tumor that is resistant to standard therapy or for which no standard therapy is available
Diagnosis of solid tumor that is advanced/metastatic and resistant to standard therapy or for whom no standard therapy is available
Have advanced or metastatic disease refractory to standard curative or palliative therapy or contraindication to standard therapy
Advanced or metastatic solid tumor refractory to standard therapy
Patients with a malignancy that is either refractory to standard therapy or for which no standard therapy is available.
Pathologically documented, definitively diagnosed, advanced solid tumor that is refractory to standard treatment, or which no standard therapy is available, or the subject refuses standard therapy or multiple myeloma
Participants with histologic documentation of locally advanced, recurrent, or metastatic incurable malignancy that has progressed after at least one available standard therapy; or for whom standard therapy has proven to be ineffective or intolerable, or is considered inappropriate; or for whom a clinical trial of an investigational agent is a recognized standard of care
Patients with advanced cancer should be refractory to standard therapy, relapsed after standard therapy, or have no standard therapy that improves survival by at least three months
Patients with advanced cancer, either refractory to standard therapy or for which no effective standard therapy that increases survival for at least months if available
Diagnosed with advanced refractory solid malignancies or intolerant of standard therapy for the stage of the disease (because there is currently no standard approved therapy for adenoid cystic carcinoma, therefore there is no requirement of prior therapy for this patient population)
Patients with advanced or metastatic cancer that is refractory to standard therapy, relapsed after standard therapy, or has no standard therapy that improves survival by at least three months
Patients with locally advanced or metastatic HPV associate malignancy (cervical, vaginal, vulvar, penile, anal, or oropharyngeal carcinoma), either refractory to standard therapy or for which no effective standard therapy that confers clinical benefit is available
Participant in the dose escalation cohorts must have histological confirmation of locally advanced or metastatic solid tumor that is either refractory after standard of care therapy for the disease or for which standard of care therapy or does not exist.
For the dose escalation cohorts, histologically-proven metastatic colorectal adenocarcinoma that is refractory to prior standard treatment regimens or standard treatment was declined.
For the dose expansion cohorts, histologically-proven metastatic colorectal adenocarcinoma that is refractory to prior standard treatment regimen or standard therapy was declined.
Relapsed or refractory malignant solid tumors of any histology for which no standard curative therapy is available (escalation phase).
Patients with advanced cancer who are refractory to, have demonstrated intolerance to, or have refused access to, available standard therapies