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

Running, not enrolling · Phase 1/Phase 2

Conditions studied: Advanced Cancer, Gastric Cancer, Gastroesophageal-junction Cancer, Pancreatic Cancer

In brief

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.

Key facts

Study ID

NCT04396821

Run by

Suzhou Transcenta Therapeutics Co., Ltd.

People needed

150

Starts

2020-05-28

Expected to finish

2026-11-30

Last updated by the study team

2025-12-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female ≥ 18 years.
• Patients with histologically or cytologically confirmed, locally advanced or metastatic solid tumors.
• Part A only:
• Patients must be: a) progressed after standard therapies, b) intolerant of standard therapies, or c) with a tumor type without standard therapy.
• Part B only:
• Cohort A: Patients with previously untreated, unresectable, locally advanced or metastatic GC/GEJ adenocarcinoma; prior adjuvant or neoadjuvant therapy are allowed only if disease progressed or recurred at least 6 months after completion of these treatments. Patients may have received one infusion of mFOLFOX6 plus nivolumab during the screening period.
• Cohort B: Patients with GC/GEJ adenocarcinoma who have radiologically progressed following one or two prior systemic therapies; adjuvant or neoadjuvant therapy could be regarded as one line of therapy only if disease progressed or recurred during these treatments or within 6 months or less after completion of these treatments.
• Cohort C: Patients with previously untreated, unresectable, locally advanced or metastatic histologically confirmed pancreatic adenocarcinoma; prior adjuvant or neoadjuvant therapy are allowed only if disease progressed or recurred at least 6 months after completion of these treatments. Patients may have received up to 2 infusions of Gemcitabine + albumin-bound paclitaxel (with one week between each infusion) during the screening period.
• Eastern Cooperative Oncology Group Performance Status (ECOG PS): 0-1 .
• Patients with adequate cardiac, liver, renal function, etc.

You may not qualify if…

• Symptomatic central nervous system metastases.
• Prior treatment with any CLDN18.2 target agents
• Allergy or sensitivity to TST001 or known allergies to comparable drugs
• Documented history of multiple other allergies requiring interventions
• Severe cardiovascular disease, including CVA, TIA, myocardial infarction, or unstable angina, NYHA class III or IV heart failure or uncontrolled arrhythmia within 6 months of study entry, severe QTc prolongation, concomitant risks for QTc prolongation.
• Concurrent malignancy within 5 years prior to entry except adequately treated certain types of cancer
• Active and clinically significant infections, known uncontrolled infections with hepatitis B, hepatitis C, known human immunodeficiency virus with acquired immunodeficiency syndrome related illness
• Any condition that the investigator or primary physician believes may not be appropriate for participating in the study.
• Other protocol-defined Inclusion/Exclusion Criteria could apply.

Where it is running

• 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

Full record on ClinicalTrials.gov

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