Phase 1 Study Evaluating BA3182 in Patients With Advanced Adenocarcinoma.

Advanced Adenocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05808634
• Other study ID #: BA3182-001
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: April 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2023
• Source: BioAtla, Inc.
• Contact: Ji Hwan Lee
• Phone: 18582867702
• Email: jlee[@]bioatla.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 168
• Est. completion date: December 31, 2025
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Advanced Adenocarcinoma

Intervention

Drug:
• BA3182
Conditionally active biologic (CAB)-bispecific T-cell engager antibody construct targeting EpCAM

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
BioAtla, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part 1: Assess dose limiting toxicity as defined in the protocol	Phase 1 Part 1: Safety Profile of BA3182	Up to 24 months
Primary	Part 1: Assess maximum tolerated dose as defined in the protocol	Phase 1 Part 1: Safety Profile of BA3182	Up to 24 months
Primary	Part 2: Confirmed overall response rate (ORR) per RECIST v1.1	Phase 1 Part 2: Antitumor activity of BA3182	Up to 24 months
Secondary	Confirmed overall response rate (ORR) per RECIST v1.1	Phase 1 Part 1: Antitumor activity of BA3182	Up to 24 months
Secondary	Confirmed best overall response best overall response (BOR)	Phase 1: Antitumor activity of BA3182	Up to 24 months
Secondary	Confirmed duration of response (DOR)	Phase 1: Antitumor activity of BA3182	Up to 24 months
Secondary	Confirmed progression-free survival (PFS)	Phase 1: Antitumor activity of BA3182	Up to 24 months
Secondary	Confirmed disease control rate (DCR)	Phase 1: Antitumor activity of BA3182	Up to 24 months
Secondary	Confirmed time to response (TTR)	Phase 1: Antitumor activity of BA3182	Up to 24 months
Secondary	Confirmed overall survival (OS)	Phase 1: Antitumor activity of BA3182	Up to 24 months
Secondary	Confirmed percent change from baseline in target lesion sum of diameters.	Phase 1: Antitumor activity of BA3182	Up to 24 months
Secondary	Area under the plasma concentration versus time curve (AUC)	Phase 1: Pharmacokinetics of BA3182	Up to 24 months
Secondary	Peak Plasma Concentration (Cmax) Phase 1: Pharmacokinetics	Phase 1: Pharmacokinetics of BA3182	Up to 24 months
Secondary	Incidence of anti-drug antibody (ADAs) to BA3182 Phase 1: Pharmacokinetics Phase 1: Immunogenicity	Phase 1: Immunogenicity of BA3182	Up to 24 months
Secondary	Incidence of neutralizing antibodies (nAbs) to BA3182.	Phase 1: Immunogenicity of BA3182	Up to 24 months