Phase 1 Study Evaluating BA3182 in Patients With Advanced Adenocarcinoma.

Study Overview
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Brief Summary
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The objective of this study is to assess safety and efficacy of BA3182 in Advanced Adenocarcinoma

Detailed Description
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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.

Official Title
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An Open-label, Multicenter, Phase 1 Study Evaluating the Safety, Pharmacokinetics, and Efficacy of BA3182, a Bispecific Epithelial Cell Adhesion Molecule (EpCAM)/CD3 Antibody, in Patients With Advanced Adenocarcinoma

Conditions
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Advanced Adenocarcinoma

Intervention / Treatment
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* Drug: BA3182


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BA3182<br>All Patients will receive BA3182 | Drug: BA3182<br>* Conditionally active biologic (CAB)-bispecific T-cell engager antibody construct targeting EpCAM<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Part 1: Assess dose limiting toxicity as defined in the protocol | Phase 1 Part 1: Safety Profile of BA3182 | Up to 24 months | 
| Part 1: Assess maximum tolerated dose as defined in the protocol | Phase 1 Part 1: Safety Profile of BA3182 | Up to 24 months | 
| Part 2: Confirmed overall response rate (ORR) per RECIST v1.1 | Phase 1 Part 2: Antitumor activity of BA3182 | Up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Confirmed overall response rate (ORR) per RECIST v1.1 | Phase 1 Part 1: Antitumor activity of BA3182 | Up to 24 months | 
| Confirmed best overall response best overall response (BOR) | Phase 1: Antitumor activity of BA3182 | Up to 24 months | 
| Confirmed duration of response (DOR) | Phase 1: Antitumor activity of BA3182 | Up to 24 months | 
| Confirmed progression-free survival (PFS) | Phase 1: Antitumor activity of BA3182 | Up to 24 months | 
| Confirmed disease control rate (DCR) | Phase 1: Antitumor activity of BA3182 | Up to 24 months | 
| Confirmed time to response (TTR) | Phase 1: Antitumor activity of BA3182 | Up to 24 months | 
| Confirmed overall survival (OS) | Phase 1: Antitumor activity of BA3182 | Up to 24 months | 
| Confirmed percent change from baseline in target lesion sum of diameters. | Phase 1: Antitumor activity of BA3182 | Up to 24 months | 
| Area under the plasma concentration versus time curve (AUC) | Phase 1: Pharmacokinetics of BA3182 | Up to 24 months | 
| Peak Plasma Concentration (Cmax) Phase 1: Pharmacokinetics | Phase 1: Pharmacokinetics of BA3182 | Up to 24 months | 
| Incidence of anti-drug antibody (ADAs) to BA3182 Phase 1: Pharmacokinetics Phase 1: Immunogenicity | Phase 1: Immunogenicity of BA3182 | Up to 24 months | 
| Incidence of neutralizing antibodies (nAbs) to BA3182. | Phase 1: Immunogenicity of BA3182 | Up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advanced, Metastatic, Cancer