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NCT04900818PHASE1Recruiting

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

I-Mab Biopharma US Limited

Start Date

6/29/2021

Completion Date

12/1/2027

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 Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

TJ033721 (givastomig)

DRUG

TJ033721 (givastomig) , nivolumab, chemotherapy

DRUG

TJ033721 (givastomig), chemotherapy

DRUG

TJ033721 (givastomig), durvalumab, chemotherapy

Interested in This Trial?

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Conditions

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

Locations

Stern Center for Cancer Clinical Trials and Research

Orange, California 92868

United States

UCHealth Cancer Care - Anschutz Medical Campus

Aurora, Colorado 80045

United States

Horizon Oncology Research, LLC.

Layfayette, Indiana 47905

United States

Mass General Hospital

Boston, Massachusetts 02114

United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey 08901

United States

NYU Langone

New York, New York 10016

United States

Memorial Sloan Kettering Cancer Center

New York, New York 10065

United States

Carolina BioOncology Institute

Huntersville, North Carolina 28078

United States

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee 37232

United States

Mary Crowley Cancer Research

Dallas, Texas 75230

United States

UW Carbone Cancer Center

Madison, Wisconsin 53705

United States

The Second Hospital of Anhui Medical University

Hefei, Anhui 230601

China

Beijing Cancer Hospital

Beijing, Beijing Municipality 100142

China

Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong 510655

China

HARBIN Medical University Cancer Hospital

Harbin, Heilongjiang 150086

China

Henan Cancer Hospital

Zhengzhou, Henan 45003

China

Hubei Cancer Hospital

Wuhan, Hubei 430079

China

The First Hospital of China Medical University

Shenyang, Liaoning 110499

China

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality 200032

China

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality 300060

China

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang 3110020

China