BA3071: Conditionally active biologic (CAB) antibody that binds to CTLA-4
Nivolumab: Humanized, immunoglobulin G4 (IgG4)-variant mAb against PD-1
Pembrolizumab: Humanized antibody, immunoglobulin G4, with a variable region against the human PD-1 receptor
Pemetrexed (Alimta): pemetrexed with either cisplatin or carboplatin
Study summary
The objective of this study is to assess safety and efficacy of BA3071 in solid tumors
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
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
Trial sites (12)
Facility
City
Region
Status
The Angeles Clinic and Research Institute
Los Angeles
California
USC Norris Comprehensive Cancer Center
Los Angeles
California
Piedmont West
Atlanta
Georgia
Northwest Cancer Centers
Dyer
Indiana
Morristown Medical Center/Atlantic Health System
Morristown
New Jersey
Icahn School of Medicine at Mt. Sinai
New York
New York
University Hospitals Cleveland Medical Center
Cleveland
Ohio
Providence Cancer Institute
Portland
Oregon
University of Utah Huntsman Cancer Institute
Salt Lake City
Utah
Border Medical Oncology Research Unit at Albury Wodonga Regional Cancer Centre
Albury
New South Wales
Cancer Care Foundation
Miranda
New South Wales
Cancer Research South Australia
Adelaide
South Australia
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.