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Evaluating TJ033721 for advanced or metastatic solid tumors

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

PHASE1 · I-Mab Biopharma US Limited · NCT04900818

This study is testing a new drug called TJ033721 to see if it can help people with advanced or metastatic solid tumors, both on its own and in combination with other treatments.

Quick facts

PhasePHASE1
Study typeInterventional
Enrollment330 (estimated)
Ages18 Years and up
SexAll
SponsorI-Mab Biopharma US Limited (industry)
Locations21 sites (Orange, California and 20 other locations)
Trial IDNCT04900818 on ClinicalTrials.gov

What this trial studies

This Phase 1 clinical trial is an open-label, multi-center study designed to assess the safety, tolerability, maximum tolerated dose (MTD), pharmacokinetics (PK), and pharmacodynamics (PD) of TJ033721 (givastomig) in patients with advanced or metastatic solid tumors. The trial includes two parts: one focusing on monotherapy for patients whose disease has progressed despite standard treatments, and another examining combination therapy for treatment-naïve patients with specific types of gastric and gastroesophageal junction cancers. Participants will receive TJ033721 along with nivolumab and chemotherapy as part of the treatment regimen.

Who should consider this trial

Good fit: Ideal candidates include individuals with advanced or metastatic solid tumors that have progressed despite standard therapies or those who are unsuitable for available treatments.

Not a fit: Patients who have previously received CLDN18.2-targeted therapy or 4-1BB agonists may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced or metastatic solid tumors who have limited treatment alternatives.

How similar studies have performed: Other studies involving similar immunotherapy approaches have shown promising results, indicating potential for success in this novel treatment.

Eligibility criteria

Show full inclusion / exclusion 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;

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

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, 3, 4 Combination subjects:

• Prior treatment with anti-PD-1 or PD-L1 agent

Where this trial is running

Orange, California and 20 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

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

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.