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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
Cancer Categories
Breast,Gastrointestinal (GI),Genitourinary (GU),Lung
Karmanos Trial ID
2023-052
NCT ID
NCT05808634
Age Group
Adult
Scope
National
Phase
Phase I
Includes initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients.
Phase I
Principal Investigator
Tarik
Hadid, M.D., MPH, MS, FACP
Oncology - Medical
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Objective:
Part 1
Primary Objective:
To define the safety profile, including dose-limiting toxicity (DLT), and determine the maximum tolerated dose (MTD) and/or pharmacologically active dose (PAD) and other safety parameters for BA3182 in patients with advanced adenocarcinoma
Secondary Objectives:
To evaluate the preliminary antitumor activity of BA3182
To characterize the pharmacokinetics (PK) of BA3182
To evaluate the immunogenicity of BA3182
Part 2
Primary Objective:
To assess antitumor activity of BA3182 in patients with adenocarcinoma expressing EpCAM
To assess the safety of BA3182 evaluating the totality of the safety data
To determine the recommended Phase 2 dose (RP2D)
Secondary Objectives:
To further assess antitumor activity of BA3182
To assess the PK of BA3182
To evaluate the immunogenicity of BA3182
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Eligibility
Locations
Applicable Disease Site
Therapies | Drugs | Devices
Eligibility
Eligibility
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.
Locations
Locations
Karmanos Cancer Institute - Detroit Headquarters
4100 John R
Detroit, MI 48201
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Phone:
1-800-527-6266
Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills
31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone:
1-800-527-6266
Applicable Disease Site
Applicable Disease Site
Breast; Colon; Esophagus; Lung; Pancreas; Prostate; Stomach
Therapies, Drugs, Devices
Therapies | Drugs | Devices
Therapies
Immunotherapy
Drugs
BA3182
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