Study of TJ033721 (Givastomig) in Subjects With Advanced or Metastatic Solid Tumors

Recruiting now · Phase 1

Conditions studied: Solid Tumor, Advanced Cancer, Metastatic Cancer, Gastric Cancer, Gastroesophageal Junction Carcinoma, Esophageal Adenocarcinoma, PDAC - Pancreatic Ductal Adenocarcinoma, Biliary Tract Cancer (BTC)

In brief

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.

Key facts

Study ID

NCT04900818

Run by

I-Mab Biopharma US Limited

People needed

330

Starts

2021-06-29

Expected to finish

2027-12-01

Last updated by the study team

2026-03-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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;
• Part 3: Combination Therapy Subjects with unresectable, locally advanced or metastatic histologically confirmed pancreatic adenocarcinoma;
• Part 4: Combination Therapy Subjects with unresectable, locally advanced or metastatic histologically confirmed biliary tract cancer.
• 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, Part 3, Part 4 Combination subjects:
• Must have CLDN18.2-positive tumor expression

You may not qualify if…

• 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, 3, 4 Combination subjects:
• Prior treatment with anti-PD-1 or PD-L1 agent

Where it is running

• Stern Center for Cancer Clinical Trials and Research — Orange, California, United States (enrolling)
• UCHealth Cancer Care - Anschutz Medical Campus — Aurora, Colorado, United States (enrolling)
• Mass General Hospital — Boston, Massachusetts, United States (enrolling)
• NYU Langone — New York, New York, United States (enrolling)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
• UW Carbone Cancer Center — Madison, Wisconsin, United States (enrolling)
• Beijing Cancer Hospital — Beijing, Beijing Municipality, China (enrolling)
• Carolina BioOncology Institute — Huntersville, North Carolina, United States
• Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States
• Mary Crowley Cancer Research — Dallas, Texas, United States
• Tianjin Medical University Cancer Institute and Hospital — Tianjin, Tianjin Municipality, China
• The Second Hospital of Anhui Medical University — Hefei, Anhui, China
• Sir Run Run Shaw Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China
• Sixth Affiliated Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China
• HARBIN Medical University Cancer Hospital — Harbin, Heilongjiang, China
• Henan Cancer Hospital — Zhengzhou, Henan, China
• Horizon Oncology Research, LLC. — Layfayette, Indiana, United States
• Hubei Cancer Hospital — Wuhan, Hubei, China
• Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States
• The First Hospital of China Medical University — Shenyang, Liaoning, China
• Zhongshan Hospital, Fudan University — Shanghai, Shanghai Municipality, China

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.