Phase 1 Study Evaluating BA3182 in Patients With Advanced... | NCT05808634

Studies
Phase 1 Study Evaluating BA3182 in Patients With Advanced Adenocarcinoma.

NCT05808634

Sponsor

BioAtla, Inc.

Status

Recruiting

Last Update Posted

Sep 25, 2025Actual

Enrollment

168Estimated

Phase

Phase 1

Conditions

Advanced Adenocarcinoma

Interventions

BA3182

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 14, 2023Actual

Primary Completion Date

Sep 15, 2028Estimated

Completion Date

Sep 15, 2028Estimated

First Submitted Date

Mar 17, 2023

First Submission Date that Met QC Criteria

Apr 10, 2023

First Posted Date

Apr 11, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 22, 2025

Last Update Posted Date

Sep 25, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

168Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BA3182	Experimental	All Patients will receive BA3182	Drug: BA3182

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BA3182	Drug	Conditionally active biologic (CAB)-bispecific T-cell engager antibody construct targeting EpCAM	BA3182

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
BioAtla Medical Affairs	Contact	858-558-0708	3333	medicalaffairs@bioatla.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UC Irvine	Recruiting	Irvine	California	92697	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009362	Neoplasm Metastasis
D009369	Neoplasms

Ancestor Terms

ID	Term
D009385	Neoplastic Processes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided