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RecruitingInterventionalPhase 1

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

NCT ID: NCT04900818Sponsor: I-Mab Biopharma US LimitedLast updated: 2026-03-05

Summary

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.

Arms & interventions

  • DrugTJ033721 (givastomig)

    Tetravalent IgG(H)-scFv fusion-type of bi-specific antibody (BsAb)

  • DrugTJ033721 (givastomig) , nivolumab, chemotherapy

    Tetravalent IgG(H)-scFv fusion-type of bi-specific antibody (BsAb), nivolumab, chemotherapy

  • DrugTJ033721 (givastomig), chemotherapy

    Tetravalent IgG(H)-scFv fusion-type of bi-specific antibody (BsAb), chemotherapy

  • DrugTJ033721 (givastomig), durvalumab, chemotherapy

    Tetravalent IgG(H)-scFv fusion-type of bi-specific antibody (BsAb), durvalumab, chemotherapy

Outcome measures

Primary

  • Dose-limiting toxicities (DLTs)

    Time frame: 28 days

  • Incidence and severity of AEs

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

    Time frame: Up to 100 days post last dose

  • Maximum tolerated or administered dose (MTD, MAD)

    Based on DLT definitions

    Time frame: 28 Days

Secondary

  • Pharmacokinetic (PK) Parameters: AUC∞

    Time frame: Up to 100 days post last dose

  • Pharmacokinetic (PK) Parameters: AUCt

    Time frame: up to 100 days post last dose

  • Pharmacokinetic (PK) Parameters: Cmax

    Time frame: up to 100 days post last dose

  • Pharmacokinetic Parameters: Tmax

    Time frame: up to 100 days post last dose

  • Pharmacokinetic Parameters: T1/2

    Time frame: up to 100 days post last dose

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (11)

Stern Center for Cancer Clinical Trials and Research

Orange, California, 92868

Recruiting

UCHealth Cancer Care - Anschutz Medical Campus

Aurora, Colorado, 80045

Recruiting

Horizon Oncology Research, LLC.

Layfayette, Indiana, 47905

Completed

Mass General Hospital

Boston, Massachusetts, 02114

Recruiting

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901

Completed

NYU Langone

New York, New York, 10016

Recruiting

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Recruiting

Carolina BioOncology Institute

Huntersville, North Carolina, 28078

Completed

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232

Completed

Mary Crowley Cancer Research

Dallas, Texas, 75230

Completed

UW Carbone Cancer Center

Madison, Wisconsin, 53705

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