Study of TJ033721 (givastomig) in Subjects with Advanced or Metastatic Solid Tumors
Trial Status: active
This is an open label, multi-center, multiple dose Phase 1 study to evaluate the safety, tolerability, MTD PK, and PD of TJ033721 (givastomig) in subjects with advanced or metastatic solid tumors.
Inclusion Criteria
- Inclusion Criteria: Part 1 - Monotherapy • Subjects with advanced or metastatic solid tumor in subjects whose disease has progressed despite standard therapy, or who has no further standard therapy, or who is unsuitable for available standard treatment options. Part 2 - Combination Therapy Subjects with treatment naïve locally advanced, unresectable or metastatic gastric, GEJ, esophageal adenocarcinoma; - Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 with adequate organ function - Have known PD-L1 status with prior testing by immunohistochemistry and a corresponding combined positive score (CPS) For dose expansion and Part 2 Combination subjects: • Must have CLDN18.2-positive tumor expression Exclusion Criteria - Prior exposure to CLDN18.2 -targeted therapy - Prior exposure to 4-1BB agonists - Second malignancy within the last 3 years with the exception of cutaneous squamous cell carcinoma or cutaneous basal cell carcinoma or cervical carcinoma in situ - Known active or chronic Hepatitis B or Hepatitis C, other hepatitides - Unstable/active ulcer or digestive tract bleeding within 6 weeks - Active autoimmune disease requiring systemic treatment within the past 2 years - Active interstitial lung disease (ILD) or pneumonitis or a history of ILD or pneumonitis requiring treatment - Known active CNS metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment; - New York Heart Association (NYHA) Class 3 or 4 congestive heart failure, severe/unstable angina, myocardial infarction (MI), symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack (TIA), arterial embolism, percutaneous transluminal coronary angioplasty (PTCA), or coronary artery bypass grafting (CABG) in the previous 6 months - Diagnosis of immunodeficiency such as known active HIV - Any active infection requiring parenteral treatment For Part 2 Combination subjects: • Prior treatment with anti-PD-1 or PD-L1
Additional locations may be listed on ClinicalTrials.gov for NCT04900818.
Locations matching your search criteria
United States
California
Orange
UC Irvine Health/Chao Family Comprehensive Cancer Center
Status: Active
Name Not AvailableColorado
Aurora
UCHealth University of Colorado Hospital
Status: Active
Contact: McKenna Russen
Phone: 720-848-8785
Massachusetts
Boston
Brigham and Women's Hospital
Status: Approved
Name Not AvailableDana-Farber Cancer Institute
Status: Approved
Name Not AvailableMassachusetts General Hospital Cancer Center
Status: Active
Name Not AvailableBeth Israel Deaconess Medical Center
Status: Approved
Name Not AvailableNew York
New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: Active
Name Not AvailableMemorial Sloan Kettering Cancer Center
Status: Active
Name Not AvailableTennessee
Nashville
Vanderbilt University/Ingram Cancer Center
Status: Temporarily closed to accrual
Name Not AvailableWisconsin
Madison
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Status: Active
Contact: Jeremy Kratz
Email: jdkratz@medicine.wisc.edu
University of Wisconsin Carbone Cancer Center - University Hospital
Status: Active
Name Not AvailableTrial PhasePhase I
Trial Typetreatment
Lead OrganizationI-Mab Biopharma US Limited
- Primary IDTJ033721STM101
- Secondary IDsNCI-2021-07863
- ClinicalTrials.gov IDNCT04900818