RecruitingPhase 1NCT04900818

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

Sponsor

I-Mab Biopharma US Limited

Enrollment

330 participants

Start Date

Jun 29, 2021

Study Type

INTERVENTIONAL

Conditions

Gastric Cancer Esophageal Adenocarcinoma Metastatic Cancer Advanced Cancer Solid Tumor Gastroesophageal Junction Carcinoma PDAC - Pancreatic Ductal Adenocarcinoma Biliary Tract Cancer (BTC)

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new drug called givastomig (TJ033721) in people with advanced cancers including stomach, esophageal, pancreatic, and bile duct cancers. This drug works by targeting two proteins on cancer cells to help the immune system fight the cancer. **You may be eligible if...** - You have an advanced or metastatic solid tumor that no longer responds to standard treatment, or no standard treatment exists - You are in good general health (ECOG 0 or 1) with adequate organ function - For some parts of the study, your tumor must test positive for a specific protein called CLDN18.2 - For stomach/esophageal cancer: you must be treatment-naive for advanced disease - For pancreatic or bile duct cancer: your tumor must be confirmed by biopsy **You may NOT be eligible if...** - You have previously received therapy targeting CLDN18.2 - You have previously received a 4-1BB drug - You have had another cancer in the last 3 years (with some exceptions) - You have active brain metastases or serious infections Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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

UW Carbone Cancer Center

Madison, Wisconsin, United States

The Second Hospital of Anhui Medical University

Hefei, Anhui, China

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

HARBIN Medical University Cancer Hospital

Harbin, Heilongjiang, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Hubei Cancer Hospital

Wuhan, Hubei, China

The First Hospital of China Medical University

Shenyang, Liaoning, China

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT04900818

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