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Phase 1 Study Evaluating BA3182 in Patients With Advanced Adenocarcinoma.

Primary Purpose

Advanced Adenocarcinoma

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
BA3182
Sponsored by
BioAtla, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Adenocarcinoma focused on measuring Advanced, Metastatic, Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    BA3182

    Arm Description

    All Patients will receive BA3182

    Outcomes

    Primary Outcome Measures

    Part 1: Assess dose limiting toxicity as defined in the protocol
    Phase 1 Part 1: Safety Profile of BA3182
    Part 1: Assess maximum tolerated dose as defined in the protocol
    Phase 1 Part 1: Safety Profile of BA3182
    Part 2: Confirmed overall response rate (ORR) per RECIST v1.1
    Phase 1 Part 2: Antitumor activity of BA3182

    Secondary Outcome Measures

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

    Full Information

    First Posted
    March 17, 2023
    Last Updated
    April 10, 2023
    Sponsor
    BioAtla, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05808634
    Brief Title
    Phase 1 Study Evaluating BA3182 in Patients With Advanced Adenocarcinoma.
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 1, 2023 (Anticipated)
    Primary Completion Date
    February 28, 2025 (Anticipated)
    Study Completion Date
    December 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    BioAtla, Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Advanced Adenocarcinoma
    Keywords
    Advanced, Metastatic, Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    168 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    BA3182
    Arm Type
    Experimental
    Arm Description
    All Patients will receive BA3182
    Intervention Type
    Drug
    Intervention Name(s)
    BA3182
    Intervention Description
    Conditionally active biologic (CAB)-bispecific T-cell engager antibody construct targeting EpCAM
    Primary Outcome Measure Information:
    Title
    Part 1: Assess dose limiting toxicity as defined in the protocol
    Description
    Phase 1 Part 1: Safety Profile of BA3182
    Time Frame
    Up to 24 months
    Title
    Part 1: Assess maximum tolerated dose as defined in the protocol
    Description
    Phase 1 Part 1: Safety Profile of BA3182
    Time Frame
    Up to 24 months
    Title
    Part 2: Confirmed overall response rate (ORR) per RECIST v1.1
    Description
    Phase 1 Part 2: Antitumor activity of BA3182
    Time Frame
    Up to 24 months
    Secondary Outcome Measure Information:
    Title
    Confirmed overall response rate (ORR) per RECIST v1.1
    Description
    Phase 1 Part 1: Antitumor activity of BA3182
    Time Frame
    Up to 24 months
    Title
    Confirmed best overall response best overall response (BOR)
    Description
    Phase 1: Antitumor activity of BA3182
    Time Frame
    Up to 24 months
    Title
    Confirmed duration of response (DOR)
    Description
    Phase 1: Antitumor activity of BA3182
    Time Frame
    Up to 24 months
    Title
    Confirmed progression-free survival (PFS)
    Description
    Phase 1: Antitumor activity of BA3182
    Time Frame
    Up to 24 months
    Title
    Confirmed disease control rate (DCR)
    Description
    Phase 1: Antitumor activity of BA3182
    Time Frame
    Up to 24 months
    Title
    Confirmed time to response (TTR)
    Description
    Phase 1: Antitumor activity of BA3182
    Time Frame
    Up to 24 months
    Title
    Confirmed overall survival (OS)
    Description
    Phase 1: Antitumor activity of BA3182
    Time Frame
    Up to 24 months
    Title
    Confirmed percent change from baseline in target lesion sum of diameters.
    Description
    Phase 1: Antitumor activity of BA3182
    Time Frame
    Up to 24 months
    Title
    Area under the plasma concentration versus time curve (AUC)
    Description
    Phase 1: Pharmacokinetics of BA3182
    Time Frame
    Up to 24 months
    Title
    Peak Plasma Concentration (Cmax) Phase 1: Pharmacokinetics
    Description
    Phase 1: Pharmacokinetics of BA3182
    Time Frame
    Up to 24 months
    Title
    Incidence of anti-drug antibody (ADAs) to BA3182 Phase 1: Pharmacokinetics Phase 1: Immunogenicity
    Description
    Phase 1: Immunogenicity of BA3182
    Time Frame
    Up to 24 months
    Title
    Incidence of neutralizing antibodies (nAbs) to BA3182.
    Description
    Phase 1: Immunogenicity of BA3182
    Time Frame
    Up to 24 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ji Hwan Lee
    Phone
    18582867702
    Email
    jlee@bioatla.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Phase 1 Study Evaluating BA3182 in Patients With Advanced Adenocarcinoma.

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