A Phase 1/2 Study of BA3071 as Monotherapy and in Combination With a PD-1 Blocking Antibody (Currently Enrolling Patients With Nonsquamous or Recurrent NSCLC (Type IIB, IIIA, IV)
- Conditions
- MelanomaNSCLC
- Interventions
- Registration Number
- NCT05180799
- Lead 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%
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 320
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Combination Therapy + Chemotherapy Pembrolizumab Conditionally active biologic (CAB) antibody that binds to CTLA-4 with PD-1 inhibitor + Chemotherapy Combination Therapy + Chemotherapy Pemetrexed (Alimta) Conditionally active biologic (CAB) antibody that binds to CTLA-4 with PD-1 inhibitor + Chemotherapy Neoadjuvant Combination Therapy + Chemotherapy BA3071 Conditionally active biologic (CAB) antibody that binds to CTLA-4 with PD-1 inhibitor + Chemotherapy prior to surgical resection Neoadjuvant Combination Therapy + Chemotherapy Pembrolizumab Conditionally active biologic (CAB) antibody that binds to CTLA-4 with PD-1 inhibitor + Chemotherapy prior to surgical resection Neoadjuvant Combination Therapy + Chemotherapy Pemetrexed (Alimta) Conditionally active biologic (CAB) antibody that binds to CTLA-4 with PD-1 inhibitor + Chemotherapy prior to surgical resection BA3071 BA3071 Conditionally active biologic (CAB) antibody that binds to CTLA-4 Combination Therapy BA3071 Conditionally active biologic (CAB) antibody that binds to CTLA-4 with PD-1 inhibitor Combination Therapy Nivolumab Conditionally active biologic (CAB) antibody that binds to CTLA-4 with PD-1 inhibitor Combination Therapy Pembrolizumab Conditionally active biologic (CAB) antibody that binds to CTLA-4 with PD-1 inhibitor Combination Therapy + Chemotherapy BA3071 Conditionally active biologic (CAB) antibody that binds to CTLA-4 with PD-1 inhibitor + Chemotherapy
- Primary Outcome Measures
Name Time Method Assess dose limiting toxicity as defined in the protocol Up to 24 months Phase 1: Safety Profile
Assess maximum tolerated dose as defined in the protocol Up to 24 months Phase 1: Safety Profile
Frequency and severity of AEs and/or SAEs Up to 24 months Phase 1 and 2: Safety Profile
Confirmed overall response rate (ORR) per RECIST v1.1 Up to 24 months Phase 2: Efficacy
- Secondary Outcome Measures
Name Time Method Percent change from baseline in target lesion sum of diameters. Up to 24 months Phase 1 and 2: Efficacy
Phase 1: Pharmacokinetics Up to 24 months Plasma concentrations of MMAE
Peak Plasma Concentration (Cmax) Up to 24 months Phase 1: Pharmacokinetics
Progression-free survival (PFS) Up to 24 months Phase 1 and 2: Efficacy
Area under the plasma concentration versus time curve (AUC) Up to 24 months Phase 1: Pharmacokinetics
Confirmed overall response rate (ORR) Up to 24 months Phase 2: Efficacy
Time to response (TTR) Up to 24 months Phase 1 and 2: Efficacy
Overall survival (OS) Up to 24 months Phase 1 and 2: Efficacy
Duration of response (DOR) Up to 24 months Phase 1 and 2: Efficacy
Confirmed best overall response (BOR) Up to 24 months Phase 1 and 2: Efficacy
Disease control rate (DCR) Up to 24 months Phase 1 and 2: Efficacy
Trial Locations
- Locations (12)
Northwest Cancer Centers
🇺🇸Dyer, Indiana, United States
The Angeles Clinic and Research Institute
🇺🇸Los Angeles, California, United States
USC Norris Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
Piedmont West
🇺🇸Atlanta, Georgia, United States
Morristown Medical Center/Atlantic Health System
🇺🇸Morristown, New Jersey, United States
Icahn School of Medicine at Mt. Sinai
🇺🇸New York, New York, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
Providence Cancer Institute
🇺🇸Portland, Oregon, United States
University of Utah Huntsman Cancer Institute
🇺🇸Salt Lake City, Utah, United States
Border Medical Oncology Research Unit at Albury Wodonga Regional Cancer Centre
🇦🇺Albury, New South Wales, Australia
Cancer Care Foundation
🇦🇺Miranda, New South Wales, Australia
Cancer Research South Australia
🇦🇺Adelaide, South Australia, Australia
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