The objective of this study is to assess safety and efficacy of BA3071 in solid tumors
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%
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
320
Conditionally active biologic (CAB) antibody that binds to CTLA-4
Humanized, immunoglobulin G4 (IgG4)-variant mAb against PD-1
Humanized antibody, immunoglobulin G4, with a variable region against the human PD-1 receptor
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
Assess dose limiting toxicity as defined in the protocol
Phase 1: Safety Profile
Time frame: Up to 24 months
Assess maximum tolerated dose as defined in the protocol
Phase 1: Safety Profile
Time frame: Up to 24 months
Frequency and severity of AEs and/or SAEs
Phase 1 and 2: Safety Profile
Time frame: Up to 24 months
Confirmed overall response rate (ORR) per RECIST v1.1
Phase 2: Efficacy
Time frame: Up to 24 months
Phase 1: Pharmacokinetics
Plasma concentrations of ADC
Time frame: Up to 24 months
Phase 1: Pharmacokinetics
Plasma concentrations of total antibody
Time frame: Up to 24 months
Phase 1: Pharmacokinetics
Plasma concentrations of MMAE
Time frame: Up to 24 months
Peak Plasma Concentration (Cmax)
Phase 1: Pharmacokinetics
Time frame: Up to 24 months
Area under the plasma concentration versus time curve (AUC)
Phase 1: Pharmacokinetics
Time frame: Up to 24 months
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pemetrexed with either cisplatin or carboplatin
Northwest Cancer Centers
Dyer, Indiana, 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
...and 2 more locations
Confirmed best overall response (BOR)
Phase 1 and 2: Efficacy
Time frame: Up to 24 months
Confirmed overall response rate (ORR)
Phase 2: Efficacy
Time frame: Up to 24 months
Disease control rate (DCR)
Phase 1 and 2: Efficacy
Time frame: Up to 24 months
Time to response (TTR)
Phase 1 and 2: Efficacy
Time frame: Up to 24 months
Overall survival (OS)
Phase 1 and 2: Efficacy
Time frame: Up to 24 months
Percent change from baseline in target lesion sum of diameters.
Phase 1 and 2: Efficacy
Time frame: Up to 24 months
Duration of response (DOR)
Phase 1 and 2: Efficacy
Time frame: Up to 24 months
Progression-free survival (PFS)
Phase 1 and 2: Efficacy
Time frame: Up to 24 months