Recruiting NCT05808634
Phase 1 Study Evaluating BA3182 in Patients With Advanced Adenocarcinoma.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BA3182.
- Who it may be relevant to
- Registry conditions: Advanced Adenocarcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Drug BA3182
Conditionally active biologic (CAB)-bispecific T-cell engager antibody construct targeting EpCAM
Primary outcome measures
- Part 1: Assess dose limiting toxicity as defined in the protocol [Time frame: Up to 24 months]
- Part 1: Assess maximum tolerated dose as defined in the protocol [Time frame: Up to 24 months]
- Part 2: Confirmed overall response rate (ORR) per RECIST v1.1 [Time frame: Up to 24 months]
Secondary outcome measures (12)
- Confirmed overall response rate (ORR) per RECIST v1.1 [Time frame: Up to 24 months]
- Confirmed best overall response best overall response (BOR) [Time frame: Up to 24 months]
- Confirmed duration of response (DOR) [Time frame: Up to 24 months]
- Confirmed progression-free survival (PFS) [Time frame: Up to 24 months]
- Confirmed disease control rate (DCR) [Time frame: Up to 24 months]
- Confirmed time to response (TTR) [Time frame: Up to 24 months]
- Confirmed overall survival (OS) [Time frame: Up to 24 months]
- Confirmed percent change from baseline in target lesion sum of diameters. [Time frame: Up to 24 months]
- Area under the plasma concentration versus time curve (AUC) [Time frame: Up to 24 months]
- Peak Plasma Concentration (Cmax) Phase 1: Pharmacokinetics [Time frame: Up to 24 months]
- Incidence of anti-drug antibody (ADAs) to BA3182 Phase 1: Pharmacokinetics Phase 1: Immunogenicity [Time frame: Up to 24 months]
- Incidence of neutralizing antibodies (nAbs) to BA3182. [Time frame: Up to 24 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 9 centers
- UC Irvine — Irvine
- USC Norris Comprehensive Cancer Center — Los Angeles
- Yale Cancer Center — New Haven
- Northwestern University — Chicago
- University of Illinois — Chicago
- Karmanos Cancer Institute — Detroit
- The Christ Hospital Cancer Center — Cincinnati
- University Hospitals Cleveland Medical Center — Cleveland
- … and 1 more center
Identifiers
NCT: NCT05808634 · BA3182-001