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A Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TST001 in Advanced or Metastatic Solid Tumors | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

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

NCT04495296•Suzhou Transcenta Therapeutics Co., Ltd.

View on ClinicalTrials.gov

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Sign the Informed Consent Form (ICF) voluntarily, understand the study and be willing and able to comply with all study procedures;
•2. Male or female ≥ 18 years at signing the ICF;
•3. Suffer from histologically confirmed locally unresectable advanced or metastatic solid tumors and meet the criteria of corresponding cohort as follows:
•Part I - Mono-therapy dose escalation and expansion phase:
•1. Mono-therapy dose escalation study: The subjects who have no option of or are intolerable to SOC.
•2. Mono-therapy dose expansion study: The subjects with positive CDLN18.2 expression in tumor tissue (defined as CLDN18.2 membranous staining ≥1+ in ≥10% of tumor cells by immunohistochemistry (IHC) in the central laboratory) confirmed by the central laboratory at enrollment. The dose expansion study may include the following 3 cohorts:
•Cohort A: Subjects with G/GEJ adenocarcinoma who have no option of or are intolerable to SOC; Cohort B: Subjects with ductal adenocarcinoma of pancreas who have no option of or are intolerable to SOC; Cohort E: Subjects with other locally advanced or metastatic solid tumors excluding G/GEJ adenocarcinoma (limited to biliary tract neoplasms, lung adenocarcinoma or colorectal cancer) who have no option of or are intolerable to SOC; Part II - Dose escalation and expansion phase for combination medication
•1. Dose escalation study of combination medication (dose escalation part):
•Cohort C/G: Subjects with HER2 negative or unknown G/GEJ adenocarcinoma who have not received prior systemic chemotherapy. The subjects who have completed neoadjuvant or adjuvant chemotherapy within at least 6 months prior to the initial dosing of the study can be enrolled.
•Cohort D: The subjects with G/GEJ adenocarcinoma who have received at least prior first-line systemic chemotherapy; Cohort F: The subjects with biliary neoplasm who have not received prior systematic chemotherapy. The subjects who have completed neoadjuvant or adjuvant chemotherapy within at least 6 months prior to the initial dosing of the study can be enrolled.
+21 more criteria

Exclusion Criteria

•The subjects who meet any one of the following criteria will be excluded from participation in this study:
•1. The subjects with locally advanced or metastatic G/GEJ adenocarcinoma who are supposed to be enrolled into the combination therapy cohorts with CAPOX and CAPOX+nivolumab (Cohort C and G) have previously received systemic chemotherapy; and the subjects in the Cohort G have previously received PD1/PD-L1/CTLA4 antibody treatment. The subjects will be eligible provided that they have completed neoadjuvant or adjuvant chemotherapy at least 6 months prior to the initial dosing of the study; The subjects with locally advanced or metastatic G/GEJ adenocarcinoma who are supposed to be enrolled into the combination therapy cohort with paclitaxel (Cohort D) have previously received taxane drugs.
•2. The subjects who previously received radiotherapy within 4 weeks prior to the initial dosing of the investigational drug (the subjects who previously received local radiotherapy for bone metastases treatment within 4 weeks with the radiotherapy related AE resolved to ≤ Grade 1 will be eligible);
•3. The subjects who previously received other systematic anti-tumor drug therapies within 4 weeks or 5 half-lives prior to the initial dosing of the investigational drug (whichever is shorter); The medication (such as zoledronic acid) for bone metastases related events will not influence on the enrollment;
•4. The subjects who previously received major surgery (exclusive of aspiration biopsy) within 8 weeks prior to the initial dosing of the investigational drug, or who are expected to undergo major surgery, or who are in the conditions such as severe unhealed wound, trauma, and ulcer;
•5. The subjects who previously received targeted CLDN18.2 therapy (including CLDN18.2 monoclonal antibody, ADC, double antibody, CART);
•6. The subjects who have previous serious allergic reactions, or are intolerable to the known component of TST001 or other monoclonal antibodies (including humanized or chimeric antibodies);
•7. The subjects who are known to have immediate or delayed hypersensitivity to, be intolerable to or be forbidden from any component of the investigational drugs;
•8. The subjects who have previous serious allergic reaction or intolerance to taxane drugs (Cohort D only) or any component of CAPOX (Cohort C and G), PD1 antibody (Cohort G and H) or GP (Cohort F);
•9. The subjects in whom symptoms of brain or leptomeningeal metastases are present;
+29 more criteria

Locations (40)

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Peking University International Hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Fujian Cancer Hospital

Fuzhou, Fujian, China

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

The Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Key Dates

Start Date

August 13, 2020

Primary Completion Date

June 25, 2026

Completion Date

December 1, 2026

Last Updated

December 19, 2025

Enrollment

320

ESTIMATED participants

Conditions

Advanced Cancer

Interventions

TST001

DRUG

Oxaliplatin

DRUG

Capecitabine

DRUG

Paclitaxel

DRUG

Gemcitabine

DRUG

Cisplatin

DRUG

Nivolumab

DRUG

Contacts

Qian Wu

CONTACT

860512-67079200 Qian.wu@transcenta.com

Henry Mao

CONTACT

860512-67079200 henry.mao@transcenta.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 19, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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