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

BioAtla

Status and phase: Active, not recruiting; Phase 2; Phase 1

Conditions: Melanoma; NSCLC

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT05180799

BA3071-001

Details and patient eligibility

About

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

Full 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%

Enrollment: 320 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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320 participants in 4 patient groups

BA3071

Experimental group

Description:

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

Treatment:

Biological: BA3071

Combination Therapy

Experimental group

Description:

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

Treatment:

Biological: Nivolumab

Biological: BA3071

Biological: Pembrolizumab

Combination Therapy + Chemotherapy

Experimental group

Description:

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

Treatment:

Biological: BA3071

Drug: Pemetrexed (Alimta)

Biological: Pembrolizumab

Neoadjuvant Combination Therapy + Chemotherapy

Experimental group

Description:

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

Treatment:

Biological: BA3071

Drug: Pemetrexed (Alimta)

Biological: Pembrolizumab