Study of TJ033721 (givastomig) in Subjects with Advanced or Metastatic Solid Tumors

Description

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.

Conditions

Solid Tumor, Advanced Cancer, Metastatic Cancer, Gastric Cancer, Gastroesophageal Junction Carcinoma, Esophageal Adenocarcinoma

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

A Phase 1 Study of TJ033721 in Subjects with Advanced or Metastatic Solid Tumors

Study of TJ033721 (givastomig) in Subjects with Advanced or Metastatic Solid Tumors

Condition
Solid Tumor
Intervention / Treatment

-

Contacts and Locations

Orange

Stern Center for Cancer Clinical Trials and Research, Orange, California, United States, 92868

Aurora

UCHealth Cancer Care - Anschutz Medical Campus, Aurora, Colorado, United States, 80045

Layfayette

Horizon Oncology Research, LLC., Layfayette, Indiana, United States, 47905

Boston

Mass General Hospital, Boston, Massachusetts, United States, 02114

New Brunswick

Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States, 08901

New York

NYU Langone, New York, New York, United States, 10016

New York

Memorial Sloan Kettering Cancer Center, New York, New York, United States, 10065

Huntersville

Carolina BioOncology Institute, Huntersville, North Carolina, United States, 28078

Nashville

Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States, 37232

Dallas

Mary Crowley Cancer Research, Dallas, Texas, United States, 75230

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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)
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

I-Mab Biopharma US Limited,

Study Record Dates

2026-12