Clinical trial NCT05808634: Phase 1 Study Evaluating BA3182 in Patients With Advanced Adenocarcinoma.
Official title: An Open-label, Multicenter, Phase 1 Study Evaluating the Safety, Pharmacokinetics, and Efficacy of BA3182, a Bispecific Epithelial Cell Adhesion Molecule (EpCAM)/CD3 Antibody, in Patients With Advanced Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced Adenocarcinoma
Keywords: Advanced
Metastatic
Cancer
Lead sponsor: BioAtla, Inc.
Sponsor class: INDUSTRY
First posted: 2023-04-11
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to assess safety and efficacy of BA3182 in Advanced Adenocarcinoma

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed locally advanced unresectable or metastatic adenocarcinoma
* Age ≥ 18 years
* Adequate renal function
* Adequate liver function
* Adequate hematological function
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Exclusion Criteria:

* Patients must not have clinically significant cardiac disease.
* Patients must not have known non-controlled CNS metastasis.
* Patients must not have active autoimmune disease or a documented history of autoimmune disease.
* Patients must not have a history of ≥ Grade 3 allergic reactions to mAb therapy as wellas known or suspected allergy or intolerance to any agent given during this study.
* Patients must not incomplete recovery from the effects of major surgery or significant traumatic injury before the first dose of study treatment.
* 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 outcomes:
measure: Part 1: Assess dose limiting toxicity as defined in the protocol
timeFrame: Up to 24 months
measure: Part 1: Assess maximum tolerated dose as defined in the protocol
timeFrame: Up to 24 months
measure: Part 2: Confirmed overall response rate (ORR) per RECIST v1.1
timeFrame: Up to 24 months
Secondary outcomes:
measure: Confirmed overall response rate (ORR) per RECIST v1.1
timeFrame: Up to 24 months
measure: Confirmed best overall response best overall response (BOR)
timeFrame: Up to 24 months
measure: Confirmed duration of response (DOR)
timeFrame: Up to 24 months
measure: Confirmed progression-free survival (PFS)
timeFrame: Up to 24 months
measure: Confirmed disease control rate (DCR)
timeFrame: Up to 24 months
measure: Confirmed time to response (TTR)
timeFrame: Up to 24 months
measure: Confirmed overall survival (OS)
timeFrame: Up to 24 months
measure: Confirmed percent change from baseline in target lesion sum of diameters.
timeFrame: Up to 24 months
measure: Area under the plasma concentration versus time curve (AUC)
timeFrame: Up to 24 months
measure: Peak Plasma Concentration (Cmax) Phase 1: Pharmacokinetics
timeFrame: Up to 24 months
measure: Incidence of anti-drug antibody (ADAs) to BA3182 Phase 1: Pharmacokinetics Phase 1: Immunogenicity
timeFrame: Up to 24 months
measure: Incidence of neutralizing antibodies (nAbs) to BA3182.
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Irvine
country: United States
facility: UC Irvine
state: California
city: Los Angeles
country: United States
facility: USC Norris Comprehensive Cancer Center
state: California
city: New Haven
country: United States
facility: Yale Cancer Center
state: Connecticut
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: University of Illinois
state: Illinois
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Cincinnati
country: United States
facility: The Christ Hospital Cancer Center
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Seattle
country: United States
facility: Fred Hutch Cancer Center
state: Washington
Study officials:
References: