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

The objective of this study is to assess safety and efficacy of BA3071 in solid tumors

Study Overview

• Status: Active, not recruiting
• Conditions: Melanoma; NSCLC
• Intervention / Treatment: Biological: BA3071; Biological: Nivolumab; Biological: Pembrolizumab; Drug: Pemetrexed (Alimta)

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: Interventional
• Enrollment (Estimated): 320
• Phase: Phase 2; Phase 1

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Assess dose limiting toxicity as defined in the protocol	Phase 1: Safety Profile	Up to 24 months
Assess maximum tolerated dose as defined in the protocol	Phase 1: Safety Profile	Up to 24 months
Frequency and severity of AEs and/or SAEs	Phase 1 and 2: Safety Profile	Up to 24 months
Confirmed overall response rate (ORR) per RECIST v1.1	Phase 2: Efficacy	Up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase 1: Pharmacokinetics	Plasma concentrations of ADC	Up to 24 months
Phase 1: Pharmacokinetics	Plasma concentrations of total antibody	Up to 24 months
Phase 1: Pharmacokinetics	Plasma concentrations of MMAE	Up to 24 months
Peak Plasma Concentration (Cmax)	Phase 1: Pharmacokinetics	Up to 24 months
Area under the plasma concentration versus time curve (AUC)	Phase 1: Pharmacokinetics	Up to 24 months
Confirmed best overall response (BOR)	Phase 1 and 2: Efficacy	Up to 24 months
Confirmed overall response rate (ORR)	Phase 2: Efficacy	Up to 24 months
Disease control rate (DCR)	Phase 1 and 2: Efficacy	Up to 24 months
Time to response (TTR)	Phase 1 and 2: Efficacy	Up to 24 months
Overall survival (OS)	Phase 1 and 2: Efficacy	Up to 24 months
Percent change from baseline in target lesion sum of diameters.	Phase 1 and 2: Efficacy	Up to 24 months
Duration of response (DOR)	Phase 1 and 2: Efficacy	Up to 24 months
Progression-free survival (PFS)	Phase 1 and 2: Efficacy	Up to 24 months

Collaborators and Investigators

• Sponsor: BioAtla, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2022
• Primary Completion (Actual): March 19, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: December 14, 2021
• First Submitted That Met QC Criteria: January 5, 2022
• First Posted (Actual): January 6, 2022

Study Record Updates

• Last Update Posted (Actual): June 15, 2025
• Last Update Submitted That Met QC Criteria: June 12, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: cancer; metastatic; KEAP1; KRAS; STK11; First Line Melanoma; First Line NSCLC; 1L NSCLC; Treatment Refractory Melanomas; Nonsquamous Stage IV; Nonsquamous recurrent; 1L NSCLC; Systemic Treatment Naive; Nonsquamous Stage IIB; Nonsquamous Stage IIIA; PD-L1 tumor proportion score (TPS) <1%
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Skin Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Skin Neoplasms; Melanoma; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Folic Acid Antagonists; Nucleic Acid Synthesis Inhibitors; Nivolumab; Pemetrexed; Pembrolizumab
• Other Study ID 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