The objective of this study is to assess safety and efficacy of BA3182 in Advanced Adenocarcinoma
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Histologically or cytologically confirmed locally advanced unresectable or metastatic adenocarcinoma
* Age ≥ 18 years
* Adequate renal function
* Adequate liver function
* Adequate hematological function
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Exclusion Criteria:
* Patients must not have clinically significant cardiac disease.
* Patients must not have known non-controlled CNS metastasis.
* Patients must not have active autoimmune disease or a documented history of autoimmune disease.
* Patients must not have a history of ≥ Grade 3 allergic reactions to mAb therapy as wellas known or suspected allergy or intolerance to any agent given during this study.
* Patients must not incomplete recovery from the effects of major surgery or significant traumatic injury before the first dose of study treatment.
* Patients must not have known human immunodeficiency virus (HIV) infection, active hepatitis B and/or hepatitis C.
* Patients must not be women who are pregnant or breast feeding.
Primary outcome measure(s)
Part 1: Assess dose limiting toxicity as defined in the protocol — Up to 24 months Phase 1 Part 1: Safety Profile of BA3182
Part 1: Assess maximum tolerated dose as defined in the protocol — Up to 24 months Phase 1 Part 1: Safety Profile of BA3182
Part 2: Confirmed overall response rate (ORR) per RECIST v1.1 — Up to 24 months Phase 1 Part 2: Antitumor activity of BA3182
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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