NCT04495296

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

A Phase I/IIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TST001 - Claudin18.2 Monoclonal Antibody in the Treatment of Locally Advanced or Metastatic Solid Tumors

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 320 (estimated)
• Sponsor: Suzhou Transcenta Therapeutics Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

There are two parts in the study. Part I is mono-therapy dose escalation and dose expansion study, and Part II is dose escalation and dose expansion study of combination therapy. The dose escalation study will be conducted utilizing 3+3 design with two dosing regimens, i.e. "once every 2 weeks (Q2W)" and "once every 3 weeks (Q3W)". After MTD/RP2D determined, three cohorts may be included in the expansion plan, with about 30 (20-40) subjects with positive CLDN18.2 expression be treated in each cohort, as shown below (during the study, the treatment cohorts may be adjusted or added based on the clinical and pre-clinical study data). Approximately 320-540 treated subjects in total

Conditions

• Advanced Cancer

Interventions

Type	Name	Description
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
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

Timeline

• Start date: 2020-08-13
• Primary completion: 2026-06-25
• Completion: 2026-12-01
• First posted: 2020-07-31
• Last updated: 2025-12-19

Locations

40 sites across 1 country: China