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

NCT05180799 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: BA3071-001
• Study Type: interventional
• Target: 320
• Locations: 2 countries
• Sites: 12

Brief Summary

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

Conditions

NSCLC; Melanoma

Keywords

metastatic; cancer; 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; KRAS; STK11; KEAP1; PD-L1 tumor proportion score (TPS) <1%

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (13)

• Phase 1: Pharmacokinetics

  Up to 24 months

• Phase 1: Pharmacokinetics

  Up to 24 months

• Phase 1: Pharmacokinetics

  Up to 24 months

• Peak Plasma Concentration (Cmax)

  Up to 24 months

• Area under the plasma concentration versus time curve (AUC)

  Up to 24 months

Study Arms (4)

BA3071

EXPERIMENTAL

Conditionally active biologic (CAB) antibody that binds to CTLA-4

Biological: BA3071

Combination Therapy

EXPERIMENTAL

Conditionally active biologic (CAB) antibody that binds to CTLA-4 with PD-1 inhibitor

Biological: BA3071; Biological: Nivolumab; Biological: Pembrolizumab

Combination Therapy + Chemotherapy

EXPERIMENTAL

Conditionally active biologic (CAB) antibody that binds to CTLA-4 with PD-1 inhibitor + Chemotherapy

Biological: BA3071; Biological: Pembrolizumab; Drug: Pemetrexed (Alimta)

Neoadjuvant Combination Therapy + Chemotherapy

EXPERIMENTAL

Conditionally active biologic (CAB) antibody that binds to CTLA-4 with PD-1 inhibitor + Chemotherapy prior to surgical resection

Biological: BA3071; Biological: Pembrolizumab; Drug: Pemetrexed (Alimta)

Interventions

BA3071 BIOLOGICAL

Conditionally active biologic (CAB) antibody that binds to CTLA-4

BA3071; Combination Therapy; Combination Therapy + Chemotherapy; Neoadjuvant Combination Therapy + Chemotherapy

Nivolumab BIOLOGICAL

Humanized, immunoglobulin G4 (IgG4)-variant mAb against PD-1

Combination Therapy

Pembrolizumab BIOLOGICAL

Humanized antibody, immunoglobulin G4, with a variable region against the human PD-1 receptor

Combination Therapy; Combination Therapy + Chemotherapy; Neoadjuvant Combination Therapy + Chemotherapy

Pemetrexed (Alimta) DRUG

pemetrexed with either cisplatin or carboplatin

Combination Therapy + Chemotherapy; Neoadjuvant Combination Therapy + Chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

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 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.

Sponsors & Collaborators

• BioAtla, Inc.: lead

Study Sites (12)

The Angeles Clinic and Research Institute

Los Angeles, California, 90025, United States

Location

USC Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Piedmont West

Atlanta, Georgia, 30318, United States

Location

Northwest Cancer Centers

Dyer, Indiana, 46311, United States

Location

Morristown Medical Center/Atlantic Health System

Morristown, New Jersey, 07960, United States

Location

Icahn School of Medicine at Mt. Sinai

New York, New York, 10029, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Providence Cancer Institute

Portland, Oregon, 97213, United States

Location

University of Utah Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

Border Medical Oncology Research Unit at Albury Wodonga Regional Cancer Centre

Albury, New South Wales, 2640, Australia

Location

Cancer Care Foundation

Miranda, New South Wales, 2228, Australia

Location

Cancer Research South Australia

Adelaide, South Australia, 5000, Australia

Location

MeSH Terms

Conditions

Melanoma; Neoplasm Metastasis; Neoplasms

Interventions

Nivolumab; pembrolizumab; Pemetrexed

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2021
• First Posted: January 6, 2022
• Study Start: August 3, 2022
• Primary Completion: March 19, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: June 15, 2025

Record last verified: 2024-10

Locations

AU (3); US (9)