Phase 1 Study Evaluating BA3182 in Patients With Advanced Adenocarcinoma.

BioAtla

Status and phase

Enrolling

Phase 1

Conditions

Advanced Adenocarcinoma

Treatments

Drug: BA3182

Study type

Interventional

Funder types

Industry

Identifiers

NCT05808634

BA3182-001

Details and patient eligibility

About

The objective of this study is to assess safety and efficacy of BA3182 in Advanced Adenocarcinoma

Full description

This is a multi-center, open-label, Phase 1 study designed to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity of BA3182 in patients with advanced adenocarcinoma.

Enrollment

168 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.