The objective of this study is to assess safety and efficacy of BA3182 in Advanced Adenocarcinoma
This is a multi-center, open-label, Phase 1 study designed to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity of BA3182 in patients with advanced adenocarcinoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
168
Conditionally active biologic (CAB)-bispecific T-cell engager antibody construct targeting EpCAM
UC Irvine
Irvine, California, United States
RECRUITINGUSC Norris Comprehensive Cancer Center
Los Angeles, California, United States
RECRUITINGYale Cancer Center
Part 1: Assess dose limiting toxicity as defined in the protocol
Phase 1 Part 1: Safety Profile of BA3182
Time frame: Up to 24 months
Part 1: Assess maximum tolerated dose as defined in the protocol
Phase 1 Part 1: Safety Profile of BA3182
Time frame: Up to 24 months
Part 2: Confirmed overall response rate (ORR) per RECIST v1.1
Phase 1 Part 2: Antitumor activity of BA3182
Time frame: Up to 24 months
Confirmed overall response rate (ORR) per RECIST v1.1
Phase 1 Part 1: Antitumor activity of BA3182
Time frame: Up to 24 months
Confirmed best overall response best overall response (BOR)
Phase 1: Antitumor activity of BA3182
Time frame: Up to 24 months
Confirmed duration of response (DOR)
Phase 1: Antitumor activity of BA3182
Time frame: Up to 24 months
Confirmed progression-free survival (PFS)
Phase 1: Antitumor activity of BA3182
Time frame: Up to 24 months
Confirmed disease control rate (DCR)
Phase 1: Antitumor activity of BA3182
Time frame: Up to 24 months
Confirmed time to response (TTR)
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New Haven, Connecticut, United States
Northwestern University
Chicago, Illinois, United States
RECRUITINGUniversity of Illinois
Chicago, Illinois, United States
RECRUITINGKarmanos Cancer Institute
Detroit, Michigan, United States
RECRUITINGThe Christ Hospital Cancer Center
Cincinnati, Ohio, United States
RECRUITINGUniversity Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
RECRUITINGFred Hutch Cancer Center
Seattle, Washington, United States
RECRUITINGPhase 1: Antitumor activity of BA3182
Time frame: Up to 24 months
Confirmed overall survival (OS)
Phase 1: Antitumor activity of BA3182
Time frame: Up to 24 months
Confirmed percent change from baseline in target lesion sum of diameters.
Phase 1: Antitumor activity of BA3182
Time frame: Up to 24 months
Area under the plasma concentration versus time curve (AUC)
Phase 1: Pharmacokinetics of BA3182
Time frame: Up to 24 months
Peak Plasma Concentration (Cmax) Phase 1: Pharmacokinetics
Phase 1: Pharmacokinetics of BA3182
Time frame: Up to 24 months
Incidence of anti-drug antibody (ADAs) to BA3182 Phase 1: Pharmacokinetics Phase 1: Immunogenicity
Phase 1: Immunogenicity of BA3182
Time frame: Up to 24 months
Incidence of neutralizing antibodies (nAbs) to BA3182.
Phase 1: Immunogenicity of BA3182
Time frame: Up to 24 months