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ACTIVE NOT RECRUITING
NCT04396821
PHASE1/PHASE2

A Trial to Evaluate Safety and Tolerability of TST001 in Advanced or Metastatic Solid Tumors

Sponsor: Suzhou Transcenta Therapeutics Co., Ltd.

View on ClinicalTrials.gov

Summary

This is an open label Phase I/IIa, First in Human trial of TST001, a recombinant humanized anti-Claudin 18.2 (CLDN18.2) IgG1 monoclonal antibody as monotherapy or in combination with nivolumab or standard of care. It is being tested against advanced and/or metastatic solid tumors including gastric, gastroesophageal junction, pancreatic cancers.

Official title: A Phase I/IIa Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of TST001 Administered as Monotherapy or in Combination With Nivolumab or Standard of Care in Patients With Locally Advanced or Metastatic Solid Tumors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2020-05-28

Completion Date

2026-11-30

Last Updated

2025-12-17

Healthy Volunteers

No

Interventions

DRUG

TST001

TST001 is a humanized IgG1 monoclonal antibody.

DRUG

Nivolumab Injection [Opdivo]

Nivolumab is one of the PD-1 checkpoint inhibitors, and has proved clinical benefit for multiple late-stage malignancies

DRUG

mFOLFOX6

mFOLFOX6 is a combination chemotherapy regimen including the drugs leucovorin calcium (folinic acid), fluorouracil, and oxaliplatin.

DRUG

Gemcitabine

Chemotherapy medication

DRUG

Albumin-Bound Paclitaxel

Chemotherapy medication

Locations (18)

Banner MD Anderson

Gilbert, Arizona, United States

University of Arizona

Tucson, Arizona, United States

Yale University

New Haven, Connecticut, United States

Florida Cancer Specialists

Sarasota, Florida, United States

Emory University

Atlanta, Georgia, United States

University of Kansas, School of Medicine

Kansas City, Kansas, United States

Washington University

St Louis, Missouri, United States

Memorial Sloan Kettering

New York, New York, United States

Stony Brook Cancer Center

Stony Brook, New York, United States

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

Gabrail Cancer Research

Canton, Ohio, United States

Pennsylvania Cancer Specialist Research Institute

Gettysburg, Pennsylvania, United States

Allegheny Hospital

Pittsburgh, Pennsylvania, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Vanderbilt University

Nashville, Tennessee, United States

NEXT Oncology

Austin, Texas, United States

Swedish Cancer Institute

Seattle, Washington, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States