{
"info": {
"nct_id": "NCT04104672",
"official_title": "A Phase 1 Study to Evaluate the Safety and Tolerability of AB680 Combination Therapy in Participants With Gastrointestinal Malignancies",
"inclusion_criteria": "* Histologically or cytologically confirmed metastatic pancreatic adenocarcinoma\n* Naïve to any prior treatment, including chemotherapy, biological therapy, or targeted therapy for metastatic disease\n\n * Prior adjuvant therapy (including chemotherapy and/or radiotherapy) for pancreatic adenocarcinoma is permitted if neoadjuvant or adjuvant therapy was completed at least 6 months prior to study enrollment. Prior adjuvant therapy may include Nab- paclitaxel or gemcitabine\n * Participants initially diagnosed with locally advanced pancreatic cancer who have undergone chemotherapy then resection and had no evidence of disease are eligible if relapse of metastatic disease has occurred and if the last dose of chemotherapy was received more than 6 months before study entry\n* Must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. The measurable lesion must be outside of a radiation field if the participant received prior radiation\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1\n* Confirmation that an archival tissue sample is available; if not, a new biopsy of a tumor must be obtained\n* Prior radiation therapy for metastatic disease must have been completed\n* Immunosuppressive doses of systemic medications, such as corticosteroids or absorbed topical corticosteroids (doses > 10 mg/day prednisone or equivalent) must be discontinued at least 2 weeks (14 days) before investigational product administration. Physiologic doses of corticosteroids (≤ 10 mg/day of prednisone or its equivalent) or short pulses of corticosteroids (≤ 3 days) may be permitted\n* Prior surgery that required general anesthesia or other major surgery as defined by the Investigator must be completed at least 4 weeks before investigational product administration\n* Negative tests for hepatitis B surface antigen, hepatitis C virus antibody (or hepatitis C qualitative ribonucleic acid [RNA; qualitative]), and human immunodeficiency virus (HIV)-1 and HIV-2 antibody at screening\n* Adequate organ and marrow function\n\nKey\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Significant cardiovascular disease (NYHA Class III-IV), myocardial infarction or cerebrovascular accident within 12 months of the first dose of investigational agent or history of arterial thromboembolic event, uncontrolled hypertension, unstable arrhythmia, or unstable angina within 3 months or venous thromboses within 1 month of the first dose of investigational agent.\n* Any active autoimmune disease or a documented history of autoimmune disease or history of a syndrome that required systemic steroids or immunosuppressive medications, except for vitiligo or resolved childhood asthma/atopy. Participants with asthma who require intermittent use of bronchodilators (such as albuterol) will not be excluded from this study\n* History of a syndrome that required systemic steroids or immunosuppressive medications, except for vitiligo or resolved childhood asthma/atopy. Participants with asthma who require intermittent use of bronchodilators (such as albuterol) will not be excluded from this study\n* Prior malignancy active within the previous year except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix, breast, or prostate cancer\n* Has not recovered (ie, ≤ Grade 1 or baseline) from a non-hematologic AEs due to a previously administered agent, except ≤ Grade 2 alopecia or ≤ Grade 2 neuropathy.\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply.",
"miscellaneous_criteria": "Key"
},
"inclusion_lines": [
{
"line": "* Histologically or cytologically confirmed metastatic pancreatic adenocarcinoma",
"criterions": [
{
"exact_snippets": "Histologically or cytologically confirmed metastatic pancreatic adenocarcinoma",
"criterion": "metastatic pancreatic adenocarcinoma",
"requirements": [
{
"requirement_type": "confirmation method",
"expected_value": [
"histologically",
"cytologically"
]
}
]
}
]
},
{
"line": "* Naïve to any prior treatment, including chemotherapy, biological therapy, or targeted therapy for metastatic disease",
"criterions": [
{
"exact_snippets": "Naïve to any prior treatment, including chemotherapy",
"criterion": "prior chemotherapy treatment",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "Naïve to any prior treatment, including ... biological therapy",
"criterion": "prior biological therapy treatment",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "Naïve to any prior treatment, including ... targeted therapy for metastatic disease",
"criterion": "prior targeted therapy for metastatic disease",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* Participants initially diagnosed with locally advanced pancreatic cancer who have undergone chemotherapy then resection and had no evidence of disease are eligible if relapse of metastatic disease has occurred and if the last dose of chemotherapy was received more than 6 months before study entry",
"criterions": [
{
"exact_snippets": "Participants initially diagnosed with locally advanced pancreatic cancer",
"criterion": "initial diagnosis",
"requirements": [
{
"requirement_type": "condition",
"expected_value": "locally advanced pancreatic cancer"
}
]
},
{
"exact_snippets": "have undergone chemotherapy",
"criterion": "chemotherapy",
"requirements": [
{
"requirement_type": "completion",
"expected_value": true
}
]
},
{
"exact_snippets": "resection",
"criterion": "resection",
"requirements": [
{
"requirement_type": "completion",
"expected_value": true
}
]
},
{
"exact_snippets": "had no evidence of disease",
"criterion": "evidence of disease",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "relapse of metastatic disease has occurred",
"criterion": "relapse of metastatic disease",
"requirements": [
{
"requirement_type": "occurrence",
"expected_value": true
}
]
},
{
"exact_snippets": "last dose of chemotherapy was received more than 6 months before study entry",
"criterion": "time since last chemotherapy dose",
"requirements": [
{
"requirement_type": "time elapsed",
"expected_value": {
"operator": ">",
"value": 6,
"unit": "months"
}
}
]
}
]
},
{
"line": "* Must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. The measurable lesion must be outside of a radiation field if the participant received prior radiation",
"criterions": [
{
"exact_snippets": "Must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.",
"criterion": "measurable lesion",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "lesion"
}
},
{
"requirement_type": "evaluation criteria",
"expected_value": "Response Evaluation Criteria in Solid Tumors (RECIST) v1.1"
}
]
},
{
"exact_snippets": "The measurable lesion must be outside of a radiation field if the participant received prior radiation",
"criterion": "measurable lesion location",
"requirements": [
{
"requirement_type": "location",
"expected_value": "outside of a radiation field"
}
]
}
]
},
{
"line": "* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1",
"criterions": [
{
"exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1",
"criterion": "ECOG performance status score",
"requirements": [
{
"requirement_type": "value",
"expected_value": [
"0",
"1"
]
}
]
}
]
},
{
"line": "* Confirmation that an archival tissue sample is available; if not, a new biopsy of a tumor must be obtained",
"criterions": [
{
"exact_snippets": "archival tissue sample is available",
"criterion": "archival tissue sample",
"requirements": [
{
"requirement_type": "availability",
"expected_value": true
}
]
},
{
"exact_snippets": "new biopsy of a tumor must be obtained",
"criterion": "new biopsy of a tumor",
"requirements": [
{
"requirement_type": "availability",
"expected_value": true
}
]
}
]
},
{
"line": "* Prior radiation therapy for metastatic disease must have been completed",
"criterions": [
{
"exact_snippets": "Prior radiation therapy for metastatic disease must have been completed",
"criterion": "radiation therapy for metastatic disease",
"requirements": [
{
"requirement_type": "completion",
"expected_value": true
}
]
}
]
},
{
"line": "* Immunosuppressive doses of systemic medications, such as corticosteroids or absorbed topical corticosteroids (doses > 10 mg/day prednisone or equivalent) must be discontinued at least 2 weeks (14 days) before investigational product administration. Physiologic doses of corticosteroids (≤ 10 mg/day of prednisone or its equivalent) or short pulses of corticosteroids (≤ 3 days) may be permitted",
"criterions": [
{
"exact_snippets": "Immunosuppressive doses of systemic medications, such as corticosteroids or absorbed topical corticosteroids (doses > 10 mg/day prednisone or equivalent) must be discontinued at least 2 weeks (14 days) before investigational product administration.",
"criterion": "immunosuppressive doses of systemic medications",
"requirements": [
{
"requirement_type": "discontinuation period",
"expected_value": {
"operator": ">=",
"value": 14,
"unit": "days"
}
},
{
"requirement_type": "dose",
"expected_value": {
"operator": ">",
"value": 10,
"unit": "mg/day"
}
}
]
},
{
"exact_snippets": "Physiologic doses of corticosteroids (≤ 10 mg/day of prednisone or its equivalent) or short pulses of corticosteroids (≤ 3 days) may be permitted",
"criterion": "physiologic doses of corticosteroids",
"requirements": [
{
"requirement_type": "dose",
"expected_value": {
"operator": "<=",
"value": 10,
"unit": "mg/day"
}
}
]
},
{
"exact_snippets": "short pulses of corticosteroids (≤ 3 days) may be permitted",
"criterion": "short pulses of corticosteroids",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "days"
}
}
]
}
]
},
{
"line": "* Prior surgery that required general anesthesia or other major surgery as defined by the Investigator must be completed at least 4 weeks before investigational product administration",
"criterions": [
{
"exact_snippets": "Prior surgery that required general anesthesia or other major surgery ... must be completed at least 4 weeks before investigational product administration",
"criterion": "prior surgery",
"requirements": [
{
"requirement_type": "time since completion",
"expected_value": {
"operator": ">=",
"value": 4,
"unit": "weeks"
}
}
]
}
]
},
{
"line": "* Negative tests for hepatitis B surface antigen, hepatitis C virus antibody (or hepatitis C qualitative ribonucleic acid [RNA; qualitative]), and human immunodeficiency virus (HIV)-1 and HIV-2 antibody at screening",
"criterions": [
{
"exact_snippets": "Negative tests for hepatitis B surface antigen",
"criterion": "hepatitis B surface antigen",
"requirements": [
{
"requirement_type": "test result",
"expected_value": "negative"
}
]
},
{
"exact_snippets": "Negative tests for ... hepatitis C virus antibody",
"criterion": "hepatitis C virus antibody",
"requirements": [
{
"requirement_type": "test result",
"expected_value": "negative"
}
]
},
{
"exact_snippets": "Negative tests for ... hepatitis C qualitative ribonucleic acid [RNA; qualitative]",
"criterion": "hepatitis C qualitative ribonucleic acid [RNA; qualitative]",
"requirements": [
{
"requirement_type": "test result",
"expected_value": "negative"
}
]
},
{
"exact_snippets": "Negative tests for ... human immunodeficiency virus (HIV)-1 and HIV-2 antibody",
"criterion": "human immunodeficiency virus (HIV)-1 and HIV-2 antibody",
"requirements": [
{
"requirement_type": "test result",
"expected_value": "negative"
}
]
}
]
},
{
"line": "* Adequate organ and marrow function",
"criterions": [
{
"exact_snippets": "Adequate organ and marrow function",
"criterion": "organ function",
"requirements": [
{
"requirement_type": "adequacy",
"expected_value": true
}
]
},
{
"exact_snippets": "Adequate organ and marrow function",
"criterion": "marrow function",
"requirements": [
{
"requirement_type": "adequacy",
"expected_value": true
}
]
}
]
},
{
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "healthy"
}
]
}
]
},
{
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "* Significant cardiovascular disease (NYHA Class III-IV), myocardial infarction or cerebrovascular accident within 12 months of the first dose of investigational agent or history of arterial thromboembolic event, uncontrolled hypertension, unstable arrhythmia, or unstable angina within 3 months or venous thromboses within 1 month of the first dose of investigational agent.",
"criterions": [
{
"exact_snippets": "Significant cardiovascular disease (NYHA Class III-IV)",
"criterion": "cardiovascular disease",
"requirements": [
{
"requirement_type": "severity",
"expected_value": "NYHA Class III-IV"
}
]
},
{
"exact_snippets": "myocardial infarction ... within 12 months of the first dose of investigational agent",
"criterion": "myocardial infarction",
"requirements": [
{
"requirement_type": "time since event",
"expected_value": {
"operator": "<=",
"value": 12,
"unit": "months"
}
}
]
},
{
"exact_snippets": "cerebrovascular accident within 12 months of the first dose of investigational agent",
"criterion": "cerebrovascular accident",
"requirements": [
{
"requirement_type": "time since event",
"expected_value": {
"operator": "<=",
"value": 12,
"unit": "months"
}
}
]
},
{
"exact_snippets": "history of arterial thromboembolic event",
"criterion": "arterial thromboembolic event",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
}
]
},
{
"exact_snippets": "uncontrolled hypertension",
"criterion": "hypertension",
"requirements": [
{
"requirement_type": "control",
"expected_value": "uncontrolled"
}
]
},
{
"exact_snippets": "unstable arrhythmia",
"criterion": "arrhythmia",
"requirements": [
{
"requirement_type": "stability",
"expected_value": "unstable"
}
]
},
{
"exact_snippets": "unstable angina within 3 months",
"criterion": "angina",
"requirements": [
{
"requirement_type": "stability",
"expected_value": "unstable"
},
{
"requirement_type": "time since event",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "months"
}
}
]
},
{
"exact_snippets": "venous thromboses within 1 month of the first dose of investigational agent",
"criterion": "venous thromboses",
"requirements": [
{
"requirement_type": "time since event",
"expected_value": {
"operator": "<=",
"value": 1,
"unit": "month"
}
}
]
}
]
},
{
"line": "* Any active autoimmune disease or a documented history of autoimmune disease or history of a syndrome that required systemic steroids or immunosuppressive medications, except for vitiligo or resolved childhood asthma/atopy. Participants with asthma who require intermittent use of bronchodilators (such as albuterol) will not be excluded from this study",
"criterions": [
{
"exact_snippets": "Any active autoimmune disease",
"criterion": "active autoimmune disease",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "documented history of autoimmune disease",
"criterion": "history of autoimmune disease",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "history of a syndrome that required systemic steroids or immunosuppressive medications",
"criterion": "history of syndrome requiring systemic steroids or immunosuppressive medications",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "Participants with asthma who require intermittent use of bronchodilators (such as albuterol) will not be excluded",
"criterion": "asthma requiring intermittent use of bronchodilators",
"requirements": [
{
"requirement_type": "exclusion",
"expected_value": false
}
]
}
]
},
{
"line": "* History of a syndrome that required systemic steroids or immunosuppressive medications, except for vitiligo or resolved childhood asthma/atopy. Participants with asthma who require intermittent use of bronchodilators (such as albuterol) will not be excluded from this study",
"criterions": [
{
"exact_snippets": "History of a syndrome that required systemic steroids or immunosuppressive medications",
"criterion": "syndrome requiring systemic steroids or immunosuppressive medications",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
}
]
},
{
"exact_snippets": "except for vitiligo",
"criterion": "vitiligo",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "except for ... resolved childhood asthma/atopy",
"criterion": "resolved childhood asthma/atopy",
"requirements": [
{
"requirement_type": "history",
"expected_value": false
}
]
},
{
"exact_snippets": "Participants with asthma who require intermittent use of bronchodilators (such as albuterol) will not be excluded",
"criterion": "asthma requiring intermittent use of bronchodilators",
"requirements": [
{
"requirement_type": "exclusion",
"expected_value": false
}
]
}
]
},
{
"line": "* Prior malignancy active within the previous year except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix, breast, or prostate cancer",
"criterions": [
{
"exact_snippets": "Prior malignancy active within the previous year",
"criterion": "prior malignancy",
"requirements": [
{
"requirement_type": "activity",
"expected_value": {
"operator": "=",
"value": 1,
"unit": "year"
}
}
]
},
{
"exact_snippets": "except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix, breast, or prostate cancer",
"criterion": "locally curable cancers",
"requirements": [
{
"requirement_type": "status",
"expected_value": "apparently cured"
},
{
"requirement_type": "types",
"expected_value": [
"basal cell skin cancer",
"squamous cell skin cancer",
"superficial bladder cancer",
"carcinoma in situ of the cervix",
"carcinoma in situ of the breast",
"carcinoma in situ of the prostate"
]
}
]
}
]
},
{
"line": "Note: Other protocol defined Inclusion/Exclusion criteria may apply.",
"criterions": [
{
"exact_snippets": "Other protocol defined Inclusion/Exclusion criteria",
"criterion": "protocol defined Inclusion/Exclusion criteria",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"line": "* Prior adjuvant therapy (including chemotherapy and/or radiotherapy) for pancreatic adenocarcinoma is permitted if neoadjuvant or adjuvant therapy was completed at least 6 months prior to study enrollment. Prior adjuvant therapy may include Nab- paclitaxel or gemcitabine",
"criterions": [
{
"exact_snippets": "Prior adjuvant therapy (including chemotherapy and/or radiotherapy) for pancreatic adenocarcinoma is permitted",
"criterion": "prior adjuvant therapy for pancreatic adenocarcinoma",
"requirements": [
{
"requirement_type": "permitted",
"expected_value": true
}
]
},
{
"exact_snippets": "if neoadjuvant or adjuvant therapy was completed at least 6 months prior to study enrollment",
"criterion": "completion of neoadjuvant or adjuvant therapy",
"requirements": [
{
"requirement_type": "time since completion",
"expected_value": {
"operator": ">=",
"value": 6,
"unit": "months"
}
}
]
},
{
"exact_snippets": "Prior adjuvant therapy may include Nab-paclitaxel or gemcitabine",
"criterion": "prior adjuvant therapy drugs",
"requirements": [
{
"requirement_type": "inclusion",
"expected_value": [
"Nab-paclitaxel",
"gemcitabine"
]
}
]
}
]
},
{
"line": "Key",
"criterions": []
}
],
"failed_exclusion": [
{
"line": "* Has not recovered (ie, ≤ Grade 1 or baseline) from a non-hematologic AEs due to a previously administered agent, except ≤ Grade 2 alopecia or ≤ Grade 2 neuropathy.",
"criterions": [
{
"exact_snippets": "Has not recovered (ie, ≤ Grade 1 or baseline) from a non-hematologic AEs due to a previously administered agent",
"criterion": "recovery from non-hematologic adverse events",
"requirements": [
{
"requirement_type": "severity",
"expected_value": {
"operator": "<=",
"value": 1,
"unit": "Grade"
}
},
{
"requirement_type": "baseline",
"expected_value": true
}
]
},
{
"exact_snippets": "except ≤ Grade 2 alopecia",
"criterion": "alopecia",
"requirements": [
{
"requirement_type": "severity",
"expected_value": {
"operator": "<=",
"value": 2,
"unit": "Grade"
}
}
]
},
{
"exact_snippets": "except ≤ Grade 2 neuropathy",
"criterion": "neuropathy",
"requirements": [
{
"requirement_type": "severity",
"expected_value": {
"operator": "<=",
"value": 2,
"unit": "Grade"
}
}
]
}
]
}
],
"failed_miscellaneous": [
{
"line": "Key",
"criterions": []
}
]
}