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OncoMatch/Clinical Trials/NCT04900818

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

Is NCT04900818 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies multiple treatments including TJ033721 (givastomig) and TJ033721 (givastomig) , nivolumab, chemotherapy for solid tumor.

Phase 1RecruitingI-Mab Biopharma US LimitedNCT04900818Data as of Jun 2026Location: United States · China

Treatment: TJ033721 (givastomig) · TJ033721 (givastomig) , nivolumab, chemotherapy · TJ033721 (givastomig), chemotherapy · TJ033721 (givastomig), durvalumab, chemotherapyThis 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.

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Extracted eligibility criteria

Treatments studied

Immunotherapy

TJ033721 (givastomig) , nivolumab, chemotherapyTJ033721 (givastomig), durvalumab, chemotherapy

Other

TJ033721 (givastomig)TJ033721 (givastomig), chemotherapy

Cancer type

Tumor Agnostic

Gastric Cancer

Esophageal Carcinoma

Pancreatic Cancer

Cholangiocarcinoma

Biomarker criteria

Required: PD-L1 (CD274) any tested (known PD-L1 status with prior testing by immunohistochemistry and a corresponding combined positive score (CPS))

Have known PD-L1 status with prior testing by immunohistochemistry and a corresponding combined positive score (CPS)

Required: CLDN18 2-positive (CLDN18.2-positive tumor expression)

Must have CLDN18.2-positive tumor expression

Disease stage

Required: Stage III, IV

locally advanced, unresectable or metastatic

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Cannot have received: CLDN18.2-targeted therapy

Prior exposure to CLDN18.2 -targeted therapy

Cannot have received: 4-1BB agonist

Prior exposure to 4-1BB agonists

Cannot have received: anti-PD-1 therapy

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

Cannot have received: anti-PD-L1 therapy

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

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Stern Center for Cancer Clinical Trials and Research · Orange, California
  • UCHealth Cancer Care - Anschutz Medical Campus · Aurora, Colorado
  • Mass General Hospital · Boston, Massachusetts
  • Rutgers Cancer Institute of New Jersey · New Brunswick, New Jersey
  • NYU Langone · New York, New York

Showing up to 5 US sites.

See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT04900818 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior CLDN18.2-targeted therapy, 4-1BB agonist, anti-PD-1 therapy disqualifies patients from enrollment.

Does this trial require CD274?

Yes, CD274 any tested is a required biomarker for enrollment.

Does this trial require CLDN18?

Yes, CLDN18 2-positive is a required biomarker for enrollment.

What disease stage is eligible?

Stage III or IV is required.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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