NCT05808634

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
168

participants targeted

Target at P75+ for phase_1

Timeline
29mo left

Started Jul 2023

Longer than P75 for phase_1

Geographic Reach
1 country

9 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress54%
Jul 2023Sep 2028

First Submitted

Initial submission to the registry

March 17, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

April 11, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

July 14, 2023

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2028

Last Updated

September 25, 2025

Status Verified

September 1, 2025

Enrollment Period

5.2 years

First QC Date

March 17, 2023

Last Update Submit

September 22, 2025

Conditions

Advanced Adenocarcinoma

Keywords

AdvancedMetastaticCancer

Outcome Measures

Primary Outcomes (3)

  • 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 (12)

  • Confirmed overall response rate (ORR) per RECIST v1.1

    Up to 24 months

  • Confirmed best overall response best overall response (BOR)

    Up to 24 months

  • Confirmed duration of response (DOR)

    Up to 24 months

  • Confirmed progression-free survival (PFS)

    Up to 24 months

  • Confirmed disease control rate (DCR)

    Up to 24 months

  • +7 more secondary outcomes

Study Arms (1)

BA3182

EXPERIMENTAL

All Patients will receive BA3182

Drug: BA3182

Interventions

BA3182DRUG

Conditionally active biologic (CAB)-bispecific T-cell engager antibody construct targeting EpCAM

BA3182

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

UC Irvine

Irvine, California, 92697, United States

RECRUITING

USC Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

RECRUITING

Yale Cancer Center

New Haven, Connecticut, 06511, United States

RECRUITING

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

University of Illinois

Chicago, Illinois, 60612, United States

RECRUITING

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

RECRUITING

The Christ Hospital Cancer Center

Cincinnati, Ohio, 45219, United States

RECRUITING

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

RECRUITING

Fred Hutch Cancer Center

Seattle, Washington, 98109, United States

RECRUITING

MeSH Terms

Conditions

Neoplasm MetastasisNeoplasms

Condition Hierarchy (Ancestors)

Neoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

BioAtla Medical Affairs

CONTACT

858-558-0708medicalaffairs@bioatla.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2023

First Posted

April 11, 2023

Study Start

July 14, 2023

Primary Completion (Estimated)

September 15, 2028

Study Completion (Estimated)

September 15, 2028

Last Updated

September 25, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(9)