Phase 1 Study Evaluating BA3182 in Patients With Advanced Adenocarcinoma.
Study Details
Study Description
Brief Summary
The objective of this study is to assess safety and efficacy of BA3182 in Advanced Adenocarcinoma
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Detailed 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: BA3182 All Patients will receive BA3182 |
Drug: BA3182
Conditionally active biologic (CAB)-bispecific T-cell engager antibody construct targeting EpCAM
|
Outcome Measures
Primary Outcome Measures
- 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
Secondary Outcome Measures
- Confirmed overall response rate (ORR) per RECIST v1.1 [Up to 24 months]
Phase 1 Part 1: Antitumor activity of BA3182
- Confirmed best overall response best overall response (BOR) [Up to 24 months]
Phase 1: Antitumor activity of BA3182
- Confirmed duration of response (DOR) [Up to 24 months]
Phase 1: Antitumor activity of BA3182
- Confirmed progression-free survival (PFS) [Up to 24 months]
Phase 1: Antitumor activity of BA3182
- Confirmed disease control rate (DCR) [Up to 24 months]
Phase 1: Antitumor activity of BA3182
- Confirmed time to response (TTR) [Up to 24 months]
Phase 1: Antitumor activity of BA3182
- Confirmed overall survival (OS) [Up to 24 months]
Phase 1: Antitumor activity of BA3182
- Confirmed percent change from baseline in target lesion sum of diameters. [Up to 24 months]
Phase 1: Antitumor activity of BA3182
- Area under the plasma concentration versus time curve (AUC) [Up to 24 months]
Phase 1: Pharmacokinetics of BA3182
- Peak Plasma Concentration (Cmax) Phase 1: Pharmacokinetics [Up to 24 months]
Phase 1: Pharmacokinetics of BA3182
- Incidence of anti-drug antibody (ADAs) to BA3182 Phase 1: Pharmacokinetics Phase 1: Immunogenicity [Up to 24 months]
Phase 1: Immunogenicity of BA3182
- Incidence of neutralizing antibodies (nAbs) to BA3182. [Up to 24 months]
Phase 1: Immunogenicity of BA3182
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Histologically or cytologically confirmed locally advanced unresectable or metastatic adenocarcinoma
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Age ≥ 18 years
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Adequate renal function
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Adequate liver function
-
Adequate hematological function
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Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Exclusion Criteria:
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Patients must not have clinically significant cardiac disease.
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Patients must not have known non-controlled CNS metastasis.
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Patients must not have active autoimmune disease or a documented history of autoimmune disease.
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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.
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Patients must not incomplete recovery from the effects of major surgery or significant traumatic injury before the first dose of study treatment.
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Patients must not have known human immunodeficiency virus (HIV) infection, active hepatitis B and/or hepatitis C.
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Patients must not be women who are pregnant or breast feeding.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- BioAtla, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BA3182-001