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

Official record

Identifier

NCT04396821

Recruiting locations

country

United States

Interventions studied

TST001Nivolumab Injection [Opdivo]mFOLFOX6GemcitabineAlbumin-Bound Paclitaxel

Lead sponsor

Transcenta Therapeutics (Hangzhou) Co., Ltd.

Target enrolment

150 participants

Study type

INTERVENTIONAL

Phase

Phase 1/2

Status

Active, not recruiting

First posted

May 21, 2020

Last updated on the registry

Sep 29, 2026

Age

18 Years

Sex

ALL

Study contact

No public contact is listed on the official record.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

Inclusion Criteria:

* 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.

Exclusion Criteria

* 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.

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Indexed under

Gastric Cancer