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

Status: closed to accrual

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

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)

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.

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%

Chat with us: LiveHelp
Call us: 1-800-4-CANCER
(1-800-422-6237)

Use the checklist in our guide to gather the information you’ll need.

Description