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A Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TST001 in Advanced or Metastatic Solid Tumors

NCT04495296 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2025-12-19

No results posted yet for this study

Summary

This is an open-label, multi-center, Phase I trial of TST001. Subjects with locally advanced or metastatic solid tumors will be enrolled. The study will consist of two parts: Part A is dose escalation and dose expansion phase for mono-therapy, and Part B is dose escalation and dose expansion phase for combination therapy in gastric, gastroesophageal junction(G/GEJ) and biliary tract cancer, etc.

Conditions

Interventions

DRUG

Gemcitabine

Gemcitabine will be administered by specified doses on specified day

DRUG

Cisplatin

Cisplatin will be administered by specified doses on specified days Oxaliplatin will be administered by specified doses on specified day Drug: Capecitabine Capecitabine will be administered by specified doses on specified day

DRUG

Nivolumab

Nivolumab will be administered by specified doses on specified day

DRUG

TST001

TST001 will be administered by specified doses on specified day

DRUG

Oxaliplatin

Oxaliplatin will be administered by specified doses on specified day

DRUG

Capecitabine

Capecitabine will be administered by specified doses on specified day

DRUG

Paclitaxel

Paclitaxel will be administered by specified doses on specified day

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-13
Primary Completion
2026-06-25
Completion
2026-12-01

Countries

  • China

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04495296 on ClinicalTrials.gov