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
1 other identifier
interventional
320
1 country
40
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2020
Longer than P75 for phase_1
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 23, 2020
CompletedFirst Posted
Study publicly available on registry
July 31, 2020
CompletedStudy Start
First participant enrolled
August 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 25, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
December 19, 2025
December 1, 2025
5.9 years
July 23, 2020
December 12, 2025
Conditions
Outcome Measures
Primary Outcomes (7)
Participant Safety as characterized by frequency and severity of adverse events(according to NCI CTCAE 5.0).
An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
up to 30 days following last dose.
Maximum Tolerated Dose (MTD）
The maximum tolerated dose (MTD) is commonly estimated to be the maximum dose that can be determined through DLT of two among 6 subjects administered with TST001 Q2W in 28 days cycles.
up to 28 days following first dose
Maximum Tolerated Dose (MTD）
The maximum tolerated dose (MTD) is commonly estimated to be the maximum dose that can be determined through DLT of two among 6 subjects administered with TST001 once every 3 weeks in 21 days cycles.
up to 21days following first dose
Recommended Phase 2 Dose (RP2D)
The RP2D will be determined during the dose expansion stage of the study. RP2D will be determined using available safety and efficacy data.
up to 30 days following last dose
The incidence and case number of DLT (Dose Limiting Toxicity) in subjects administered with TST001 Q2W in 28 days cycles during observation period
DLT is short for Dose Limiting Toxicity. dose-limiting describes side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment.
up to 28 days following first dose
The incidence and case number of DLT (Dose Limiting Toxicity) in subjects administered with TST001 once every 3 weeks in 21 days cycles during observation period
DLT is short for Dose Limiting Toxicity. dose-limiting describes side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment.
up to 21days following first dose
Safety and Tolerability of TST001 in combination with other therapies, e.g. CAPOX, paclitaxel, GP, nivolumab as characterized by frequency and severity of adverse events
Characterization of TST001 + CAPOX safety profile including frequency and severity of adverse events that are related to treatment.
Up to 30 or 90 days following last dose
Secondary Outcomes (9)
Area under plasma concentration vs time curve (AUC) for TST001
up to 30 days following last dose
Peak plasma concentration (Cmax) for TST001
up to 30 days following last dose
Time to maximum observed plasma concentration (Tmax)
up to 30 days following last dose
Terminal elimination half life (t1/2)
up to 30 days following last dose
Immunogenicity
up to 30 days following last dose
- +4 more secondary outcomes
Study Arms (10)
dose escalation Q2W
EXPERIMENTALDosed every 2 weeks IV with TST001, multiple dose levels will be tested.
dose escalation Q3W
EXPERIMENTALDosed every 3 weeks IV with TST001, multiple dose levels will be tested.
Cohort A
EXPERIMENTALParticipants with gastric or gastroesophageal junction cancers and CLDN18.2 expression
Cohort B
EXPERIMENTALParticipants with ductal adenocarcinoma of pancreas and CLDN18.2 expression and CLDN18.2 expression
Cohort E
EXPERIMENTALParticipants with advanced or metastatic solid tumors other than G/GEJ adenocarcinoma and CLDN18.2 expression
Cohort C
EXPERIMENTALParticipants with HER2 negative or unknown locally advanced or metastatic G/GEJ adenocarcinoma
Cohort D
EXPERIMENTALParticipants with locally advanced or metastatic G/GEJ adenocarcinoma
Cohort F
EXPERIMENTALParticipants with locally advanced or metastatic biliary tract cancer
Cohort G
EXPERIMENTALParticipants with HER2 negative or unknown locally advanced or metastatic G/GEJ adenocarcinoma
Cohort H (TST001 plus nivolumab)
EXPERIMENTALParticipants with locally advanced or metastatic G/GEJ adenocarcinoma
Interventions
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
Nivolumab will be administered by specified doses on specified day
TST001 will be administered by specified doses on specified day
Capecitabine will be administered by specified doses on specified day
Eligibility Criteria
You may qualify if:
- Sign the Informed Consent Form (ICF) voluntarily, understand the study and be willing and able to comply with all study procedures;
- Male or female ≥ 18 years at signing the ICF;
- 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:
- Mono-therapy dose escalation study: The subjects who have no option of or are intolerable to SOC.
- 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
- 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.
- Cohort H: The subjects with G/GEJ adenocarcinoma who have received at least prior second-line systemic chemotherapy;
- Dose expansion study of combination medication (dose expansion part):
- The subjects with positive CDLN18.2 expression in tumor tissue confirmed by the central laboratory will be enrolled as follows:
- 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.
- +16 more criteria
You may not qualify if:
- The subjects who meet any one of the following criteria will be excluded from participation in this study:
- 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.
- 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);
- 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;
- 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;
- The subjects who previously received targeted CLDN18.2 therapy (including CLDN18.2 monoclonal antibody, ADC, double antibody, CART);
- 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);
- 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;
- 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);
- The subjects in whom symptoms of brain or leptomeningeal metastases are present;
- The subjects with central nerve system (CNS) metastasis who meets the following conditions can be enrolled:
- The subjects with brain metastasis who have not received to any treatment and are asymptomatic, or who are radiologically stable for at least 8 weeks following treatment and do not require hormone or anti epilepsy treatment at least within 8 weeks;
- The subjects with body cavity effusion (hydrothorax, ascites and pericardial effusion) requiring local treatment or repeated drainage which is not well controlled at the discretion of the investigators;
- The subjects with concurrent malignant tumors within 3 years other than adequately treated cervical carcinoma in situ, localized squamous cell cancer of the skin, basal cell carcinoma, prostate cancer with no treatment required (with or without resection), ductal carcinoma in situ of the breast, or ≤ T1 urothelial carcinoma (for the dose expansion phase only);
- Any adverse reactions caused by previous treatment have not resolved to ≤ Grade 1 as per CTCAE v5.0 (exclusive of alopecia and anaemia) before the initial dosing of the investigational drug. If the adverse reaction has no clinical influence, the Sponsor and investigators will decide whether the subject can be enrolled in the study after discussion.
- +24 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Suzhou Transcenta Therapeutics Co., Ltd.lead
- Bristol-Myers Squibbcollaborator
Study Sites (40)
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100036, 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
The People's Hospital of Guangxi Zhuang Autonomous Region
Guangxi, Guangxi, China
Hainan Provincial People's Hospital
Haikou, Hainan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Heibei, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Hubei Cancer Hospital
Wuhan, Hubei, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
Xiangya Hospital, Central South University
Changsha, Hunan, China
Suzhou Municipal Hospital
Suzhou, Jiangsu, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Xuzhou Central Hospital
Xuzhou, Jiangsu, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Jilin Cancer Hospital
Changchun, Jilin, China
The First Hospital of Jilin University
Changchun, Jilin, China
The First Affiliated Hospital of Jinzhou Medical University
Jinzhou, Liaoning, China
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
Jinan Central Hospital
Jinan, Shandong, China
Linyi Cancer Hospital
Linyi, Shandong, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Fudan University Shanghai Cance Center
Shanghai, Shanghai Municipality, China
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, China
Sichuan Cancer Hospital
Chengdu, Sichuan, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 23, 2020
First Posted
July 31, 2020
Study Start
August 13, 2020
Primary Completion (Estimated)
June 25, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
December 19, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share