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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05180799
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1/Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	BioAtla, Inc.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Australia, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	NSCLC, Melanoma

Additional Details

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%

Arms & Interventions

Arms

Experimental: 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

Experimental: Combination Therapy + Chemotherapy

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

Experimental: Neoadjuvant Combination Therapy + Chemotherapy

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

Interventions

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

Drug: - Pemetrexed (Alimta)

pemetrexed with either cisplatin or carboplatin

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Los Angeles, California

Status

Recruiting

Address

The Angeles Clinic and Research Institute

Los Angeles, California, 90025

Site Contact

Misty Guillen

[email protected]

310-231-2183

USC Norris Comprehensive Cancer Center, Los Angeles, California

Status