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

March 3, 2026 updated by: I-Mab Biopharma US Limited

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

330

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230601
        • Withdrawn
        • The second hospital of Anhui medical university
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100142
        • Recruiting
        • Beijing Cancer Hospital
    • Guangdong
      • Guangzhou, Guangdong, China, 510655
        • Active, not recruiting
        • Sixth Affiliated Hospital, Sun Yat-sen University
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150086
        • Completed
        • Harbin medical university cancer hospital
    • Henan
      • Zhengzhou, Henan, China, 45003
        • Completed
        • Henan Cancer Hospital
    • Hubei
      • Wuhan, Hubei, China, 430079
        • Completed
        • Hubei Cancer Hospital
    • Liaoning
      • Shenyang, Liaoning, China, 110499
        • Completed
        • The First Hospital of China Medical University
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Completed
        • Zhongshan Hospital, Fudan University
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300060
        • Completed
        • Tianjin Medical University Cancer Institute and Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China, 3110020
        • Completed
        • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
  • United States
    • California
      • Orange, California, United States, 92868
        • Recruiting
        • Stern Center for Cancer Clinical Trials and Research
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • UCHealth Cancer Care - Anschutz Medical Campus
    • Indiana
      • Layfayette, Indiana, United States, 47905
        • Completed
        • Horizon Oncology Research, LLC.
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Mass General Hospital
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Completed
        • Rutgers Cancer Institute of New Jersey
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, United States, 10016
        • Recruiting
        • NYU Langone
    • North Carolina
      • Huntersville, North Carolina, United States, 28078
        • Completed
        • Carolina BioOncology Institute
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Completed
        • Vanderbilt-Ingram Cancer Center
    • Texas
      • Dallas, Texas, United States, 75230
        • Completed
        • Mary Crowley Cancer Research
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • Recruiting
        • UW Carbone Cancer Center

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TJ033721 (givastomig)

Dose Escalation: TJ033721 will be administered at up to 8 dose levels (0.1, 0.3, 1, 3, 5, 8, 12 and 15 mg/kg) bi weekly (Q2W) and 1 dose level (18 mg/kg) every 3 weeks (Q3W)

During dose expansion, TJ033721 will be administered Q2W, starting at the RP2D or MTD in dose escalation.
Drug: TJ033721 (givastomig)
Tetravalent IgG(H)-scFv fusion-type of bi-specific antibody (BsAb)
Experimental: TJ033721 (givastomig) in combination with nivolumab and chemotherapy
TJ033721 will be administered in combination with nivolumab and chemotherapy
Drug: TJ033721 (givastomig) , nivolumab, chemotherapy
Tetravalent IgG(H)-scFv fusion-type of bi-specific antibody (BsAb), nivolumab, chemotherapy
Experimental: TJ033721 (givastomig) in combination chemotherapy
TJ033721 (givastomig) will be administered in combination chemotherapy
Drug: TJ033721 (givastomig), chemotherapy
Tetravalent IgG(H)-scFv fusion-type of bi-specific antibody (BsAb), chemotherapy
Experimental: TJ033721 (givastomig) in combination with durvalumab and chemotherapy
TJ033721 (givastomig) will be administered in combination with durvalumab and chemotherapy
Drug: TJ033721 (givastomig), durvalumab, chemotherapy
Tetravalent IgG(H)-scFv fusion-type of bi-specific antibody (BsAb), durvalumab, chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose-limiting toxicities (DLTs)
Time Frame: 28 days
28 days
Incidence and severity of AEs
Time Frame: Up to 100 days post last dose
The CTCAE criteria will be used to assess adverse events on this trial.
Up to 100 days post last dose
Maximum tolerated or administered dose (MTD, MAD)
Time Frame: 28 Days
Based on DLT definitions
28 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetic (PK) Parameters: AUC∞
Time Frame: Up to 100 days post last dose
Area under the curve from time zero extrapolated to infinity (AUC∞)
Up to 100 days post last dose
Pharmacokinetic (PK) Parameters: AUCt
Time Frame: up to 100 days post last dose
AUC from time zero to the time of the last quantifiable concentration (AUC0-t)
up to 100 days post last dose
Pharmacokinetic (PK) Parameters: Cmax
Time Frame: up to 100 days post last dose
Maximum observed concentration
up to 100 days post last dose
Pharmacokinetic Parameters: Tmax
Time Frame: up to 100 days post last dose
Time of peak concentration (Tmax)
up to 100 days post last dose
Pharmacokinetic Parameters: T1/2
Time Frame: up to 100 days post last dose
Investigational Product (IP) half-life (T1/2)
up to 100 days post last dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

I-Mab Biopharma US Limited

Collaborators

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 29, 2021

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

May 20, 2021

First Submitted That Met QC Criteria

May 20, 2021

First Posted (Actual)

May 25, 2021

Study Record Updates

Last Update Posted (Actual)

March 5, 2026

Last Update Submitted That Met QC Criteria

March 3, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TJ033721STM101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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