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Study of TJ033721 (Givastomig) for Advanced Solid Tumors

This study is testing a new drug called TJ033721 (givastomig) for people with advanced or metastatic (spread) solid tumors, including gastric (stomach) cancer. Researchers want to see how safe TJ033721 (givastomig) is, what side effects it might cause, and what dose works best. The drug is being tested alone, and in combination with other treatments like nivolumab, durvalumab, or chemotherapy. You may be able to join if your cancer has progressed despite standard treatments, or if you can't receive other standard options. The study will look at side effects and how well the drug is tolerated over time.

Study design
This is an open-label, multi-center Phase 1 study, meaning both you and your doctors will know which treatment you are receiving. It plans to enroll 330 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Side effects will be monitored for up to 100 days after your last dose of treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04900818

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
I-Mab Biopharma US Limited
~330 participants
Updated 2026-03-05 on ClinicalTrials.gov
What's tested:TJ033721 (givastomig)TJ033721 (givastomig) , nivolumab, chemotherapyTJ033721 (givastomig), chemotherapyTJ033721 (givastomig), durvalumab, chemotherapy

At a glance

Recruiting sites
7 of 21 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose-limiting toxicities (DLTs)
Measured over 28 days
+2 more outcomes measured

Conditions

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

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Esophageal AdenocarcinomaGastric CarcinomaGastroesophageal Junction CarcinomaMalignant neoplasm of biliary tractPancreatic Ductal AdenocarcinomaSolid Neoplasm

Where it's being run

21 sites across 20 states
New York2
California1
Colorado1
Indiana1
Massachusetts1
New Jersey1
North Carolina1
Tennessee1

Who to contact

Clinical Development
[email protected]
(240) 745-6330
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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)

Exclusion

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

What this trial measures

  • Dose-limiting toxicities (DLTs)28 days
  • Incidence and severity of AEsUp to 100 days post last dose

    The CTCAE criteria will be used to assess adverse events on this trial.

  • Maximum tolerated or administered dose (MTD, MAD)28 Days

    Based on DLT definitions