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

INTRODUCTION

  • Org Study ID: BA3071-001
  • Secondary ID: N/A
  • NCT ID: NCT05180799
  • Sponsor: BioAtla, Inc.

BRIEF SUMMARY

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

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%

  • Overall Status
    Active, not recruiting
  • Start Date
    August 3, 2022
  • Phase
    PHASE1, PHASE2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Assess dose limiting toxicity as defined in the protocol

Primary Outcome 1 - Timeframe: Up to 24 months

Primary Outcome 2 - Measure: Assess maximum tolerated dose as defined in the protocol

Primary Outcome 2 - Timeframe: Up to 24 months

Primary Outcome 3 - Measure: Frequency and severity of AEs and/or SAEs

Primary Outcome 3 - Timeframe: Up to 24 months

Primary Outcome 4 - Measure: Confirmed overall response rate (ORR) per RECIST v1.1

Primary Outcome 4 - Timeframe: Up to 24 months

CONDITION

  • NSCLC
  • Melanoma

ELIGIBILITY

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact

Name: N/A

Phone: N/A

Email: N/A

LOCATION

Facility Status Contact