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NCT Number: NCT05808634

Phase 1 Study Evaluating BA3182 in Patients With Advanced Adenocarcinoma.

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

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Key information

Conditions

Advanced Adenocarcinoma Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

UC Irvine, Irvine, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BA3182

Drug

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

Primary outcomes

  1. Part 1: Assess dose limiting toxicity as defined in the protocol

    Time frame: Up to 24 months

    Phase 1 Part 1: Safety Profile of BA3182

  2. Part 1: Assess maximum tolerated dose as defined in the protocol

    Time frame: Up to 24 months

    Phase 1 Part 1: Safety Profile of BA3182

  3. Part 2: Confirmed overall response rate (ORR) per RECIST v1.1

    Time frame: Up to 24 months

    Phase 1 Part 2: Antitumor activity of BA3182

Secondary outcomes

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

    Time frame: Up to 24 months

    Phase 1 Part 1: Antitumor activity of BA3182

  2. Confirmed best overall response best overall response (BOR)

    Time frame: Up to 24 months

    Phase 1: Antitumor activity of BA3182

  3. Confirmed duration of response (DOR)

    Time frame: Up to 24 months

    Phase 1: Antitumor activity of BA3182

  4. Confirmed progression-free survival (PFS)

    Time frame: Up to 24 months

    Phase 1: Antitumor activity of BA3182

  5. Confirmed disease control rate (DCR)

    Time frame: Up to 24 months

    Phase 1: Antitumor activity of BA3182

  6. Confirmed time to response (TTR)

    Time frame: Up to 24 months

    Phase 1: Antitumor activity of BA3182

  7. Confirmed overall survival (OS)

    Time frame: Up to 24 months

    Phase 1: Antitumor activity of BA3182

  8. Confirmed percent change from baseline in target lesion sum of diameters.

    Time frame: Up to 24 months

    Phase 1: Antitumor activity of BA3182

  9. Area under the plasma concentration versus time curve (AUC)

    Time frame: Up to 24 months

    Phase 1: Pharmacokinetics of BA3182

  10. Peak Plasma Concentration (Cmax) Phase 1: Pharmacokinetics

    Time frame: Up to 24 months

    Phase 1: Pharmacokinetics of BA3182

  11. Incidence of anti-drug antibody (ADAs) to BA3182 Phase 1: Pharmacokinetics Phase 1: Immunogenicity

    Time frame: Up to 24 months

    Phase 1: Immunogenicity of BA3182

  12. Incidence of neutralizing antibodies (nAbs) to BA3182.

    Time frame: Up to 24 months

    Phase 1: Immunogenicity of BA3182

Study contacts

Contact information is provided by the study sponsor or research team.

BioAtla Medical Affairs

CONTACT

[email protected]

858-558-0708 ext. 3333

Sponsors and collaborators

Lead sponsor

BioAtla, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Apr 11, 2023
Registry last updated
Sep 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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