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Study of TJ033721 (Givastomig) in Subjects With Advanced or Metastatic Solid Tumors | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

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

NCT04900818•I-Mab Biopharma US Limited

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+3 more criteria

Locations (21)

Stern Center for Cancer Clinical Trials and Research

Orange, California, United States

UCHealth Cancer Care - Anschutz Medical Campus

Aurora, Colorado, United States

Horizon Oncology Research, LLC.

Layfayette, Indiana, United States

Mass General Hospital

Boston, Massachusetts, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

NYU Langone

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Carolina BioOncology Institute

Huntersville, North Carolina, United States

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

Mary Crowley Cancer Research

Dallas, Texas, United States

Key Dates

Start Date

June 29, 2021

Primary Completion Date

December 1, 2026

Completion Date

December 1, 2027

Last Updated

March 5, 2026

Enrollment

330

ESTIMATED participants

Conditions

Solid TumorAdvanced CancerMetastatic CancerGastric CancerGastroesophageal Junction CarcinomaEsophageal AdenocarcinomaPDAC - Pancreatic Ductal AdenocarcinomaBiliary Tract Cancer (BTC)

Interventions

TJ033721 (givastomig)

DRUG

TJ033721 (givastomig) , nivolumab, chemotherapy

DRUG

TJ033721 (givastomig), chemotherapy

DRUG

TJ033721 (givastomig), durvalumab, chemotherapy

DRUG

Contacts

Clinical Development

CONTACT

(240) 745-6330 us.info@imabbio.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 5, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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