A Phase 1/2 Study of BA3071 in Patients With Solid Tumors

June 12, 2025 updated by: BioAtla, Inc.
The objective of this study is to assess safety and efficacy of BA3071 in solid tumors

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a multi-center, open-label study designed to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity of BA3071. Phase 2 is open and currently recruiting patients with:

  1. Melanoma - 1L
  2. nonsquamous or recurrent NSCLC (Type IIB, IIIA, IV) with single or any combination of the following mutations: KRAS mutation STK11 mutation KEAP1 mutation PD-L1 tumor proportion score (TPS) <1%

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
320

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • New South Wales
      • Albury, New South Wales, Australia, 2640
        • Border Medical Oncology Research Unit at Albury Wodonga Regional Cancer Centre
      • Miranda, New South Wales, Australia, 2228
        • Cancer Care Foundation
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Cancer Research South Australia
  • United States
    • California
      • Los Angeles, California, United States, 90033
        • USC Norris Comprehensive Cancer Center
      • Los Angeles, California, United States, 90025
        • The Angeles Clinic and Research Institute
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Piedmont West
    • Indiana
      • Dyer, Indiana, United States, 46311
        • Northwest Cancer Centers
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Morristown Medical Center/Atlantic Health System
    • New York
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mt. Sinai
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center
    • Oregon
      • Portland, Oregon, United States, 97213
        • Providence Cancer Institute
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • University of Utah Huntsman Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients must have measurable disease.
  • Age ≥ 18 years
  • CLTA-4 blocking-antibody naïve
  • Adequate renal function
  • Adequate liver function
  • Adequate hematological function
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Patients must have single or any combination of the following mutations: KRAS, STK11, KEAP1 and/or PD-L1 TPS <1%
  • Patients must be eligible for surgery (NSCLC Stage IIB-IIIA only)

Exclusion Criteria:

  • Patients must not have clinically significant cardiac disease.
  • Patients must not have known non-controlled CNS metastasis.
  • Patients must not have a history of ≥ Grade 3 allergic reactions to mAb therapy as well as known or suspected allergy or intolerance to any agent given during this study.
  • Patients must not have had major surgery within 4 weeks before first BA3071 administration.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: BA3071
Conditionally active biologic (CAB) antibody that binds to CTLA-4
Biological: BA3071
Conditionally active biologic (CAB) antibody that binds to CTLA-4
Experimental: Combination Therapy
Conditionally active biologic (CAB) antibody that binds to CTLA-4 with PD-1 inhibitor
Biological: BA3071
Conditionally active biologic (CAB) antibody that binds to CTLA-4
Biological: Nivolumab
Humanized, immunoglobulin G4 (IgG4)-variant mAb against PD-1
Biological: Pembrolizumab
Humanized antibody, immunoglobulin G4, with a variable region against the human PD-1 receptor
Experimental: Combination Therapy + Chemotherapy
Conditionally active biologic (CAB) antibody that binds to CTLA-4 with PD-1 inhibitor + Chemotherapy
Biological: BA3071
Conditionally active biologic (CAB) antibody that binds to CTLA-4
Biological: Pembrolizumab
Humanized antibody, immunoglobulin G4, with a variable region against the human PD-1 receptor
Drug: Pemetrexed (Alimta)
pemetrexed with either cisplatin or carboplatin
Experimental: Neoadjuvant Combination Therapy + Chemotherapy
Conditionally active biologic (CAB) antibody that binds to CTLA-4 with PD-1 inhibitor + Chemotherapy prior to surgical resection
Biological: BA3071
Conditionally active biologic (CAB) antibody that binds to CTLA-4
Biological: Pembrolizumab
Humanized antibody, immunoglobulin G4, with a variable region against the human PD-1 receptor
Drug: Pemetrexed (Alimta)
pemetrexed with either cisplatin or carboplatin

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Assess dose limiting toxicity as defined in the protocol
Time Frame: Up to 24 months
Phase 1: Safety Profile
Up to 24 months
Assess maximum tolerated dose as defined in the protocol
Time Frame: Up to 24 months
Phase 1: Safety Profile
Up to 24 months
Frequency and severity of AEs and/or SAEs
Time Frame: Up to 24 months
Phase 1 and 2: Safety Profile
Up to 24 months
Confirmed overall response rate (ORR) per RECIST v1.1
Time Frame: Up to 24 months
Phase 2: Efficacy
Up to 24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Phase 1: Pharmacokinetics
Time Frame: Up to 24 months
Plasma concentrations of ADC
Up to 24 months
Phase 1: Pharmacokinetics
Time Frame: Up to 24 months
Plasma concentrations of total antibody
Up to 24 months
Phase 1: Pharmacokinetics
Time Frame: Up to 24 months
Plasma concentrations of MMAE
Up to 24 months
Peak Plasma Concentration (Cmax)
Time Frame: Up to 24 months
Phase 1: Pharmacokinetics
Up to 24 months
Area under the plasma concentration versus time curve (AUC)
Time Frame: Up to 24 months
Phase 1: Pharmacokinetics
Up to 24 months
Confirmed best overall response (BOR)
Time Frame: Up to 24 months
Phase 1 and 2: Efficacy
Up to 24 months
Confirmed overall response rate (ORR)
Time Frame: Up to 24 months
Phase 2: Efficacy
Up to 24 months
Disease control rate (DCR)
Time Frame: Up to 24 months
Phase 1 and 2: Efficacy
Up to 24 months
Time to response (TTR)
Time Frame: Up to 24 months
Phase 1 and 2: Efficacy
Up to 24 months
Overall survival (OS)
Time Frame: Up to 24 months
Phase 1 and 2: Efficacy
Up to 24 months
Percent change from baseline in target lesion sum of diameters.
Time Frame: Up to 24 months
Phase 1 and 2: Efficacy
Up to 24 months
Duration of response (DOR)
Time Frame: Up to 24 months
Phase 1 and 2: Efficacy
Up to 24 months
Progression-free survival (PFS)
Time Frame: Up to 24 months
Phase 1 and 2: Efficacy
Up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
BioAtla, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 3, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 19, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 14, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 6, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 15, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BA3071-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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