A Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TST001 in Advanced or Metastatic Solid Tumors
NCT ID: NCT04495296
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
320 participants
INTERVENTIONAL
2020-08-13
2026-12-01
Brief Summary
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort C
Participants with HER2 negative or unknown locally advanced or metastatic G/GEJ adenocarcinoma
TST001
TST001 will be administered by specified doses on specified day
Oxaliplatin
Oxaliplatin will be administered by specified doses on specified day
Capecitabine
Capecitabine will be administered by specified doses on specified day
Cohort D
Participants with locally advanced or metastatic G/GEJ adenocarcinoma
TST001
TST001 will be administered by specified doses on specified day
Paclitaxel
Paclitaxel will be administered by specified doses on specified day
Cohort F
Participants with locally advanced or metastatic biliary tract cancer
TST001
TST001 will be administered by specified doses on specified day
Gemcitabine
Gemcitabine will be administered by specified doses on specified day
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
Cohort G
Participants with HER2 negative or unknown locally advanced or metastatic G/GEJ adenocarcinoma
TST001
TST001 will be administered by specified doses on specified day
Oxaliplatin
Oxaliplatin will be administered by specified doses on specified day
Capecitabine
Capecitabine will be administered by specified doses on specified day
Nivolumab
Nivolumab will be administered by specified doses on specified day
Cohort H (TST001 plus nivolumab)
Participants with locally advanced or metastatic G/GEJ adenocarcinoma
TST001
TST001 will be administered by specified doses on specified day
Nivolumab
Nivolumab will be administered by specified doses on specified day
dose escalation Q2W
Dosed every 2 weeks IV with TST001, multiple dose levels will be tested.
TST001
TST001 will be administered by specified doses on specified day
dose escalation Q3W
Dosed every 3 weeks IV with TST001, multiple dose levels will be tested.
TST001
TST001 will be administered by specified doses on specified day
Cohort A
Participants with gastric or gastroesophageal junction cancers and CLDN18.2 expression
TST001
TST001 will be administered by specified doses on specified day
Cohort B
Participants with ductal adenocarcinoma of pancreas and CLDN18.2 expression and CLDN18.2 expression
TST001
TST001 will be administered by specified doses on specified day
Cohort E
Participants with advanced or metastatic solid tumors other than G/GEJ adenocarcinoma and CLDN18.2 expression
TST001
TST001 will be administered by specified doses on specified day
Interventions
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TST001
TST001 will be administered by specified doses on specified day
Oxaliplatin
Oxaliplatin will be administered by specified doses on specified day
Capecitabine
Capecitabine will be administered by specified doses on specified day
Paclitaxel
Paclitaxel will be administered by specified doses on specified day
Gemcitabine
Gemcitabine will be administered by specified doses on specified day
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
Nivolumab
Nivolumab will be administered by specified doses on specified day
Eligibility Criteria
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Inclusion Criteria
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.
Cohort H: The subjects with G/GEJ adenocarcinoma who have received at least prior second-line systemic chemotherapy;
2. 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.
Cohort H: The subjects with G/GEJ adenocarcinoma who have received at least prior second-line systemic chemotherapy;
4. ECOG performance status of 0-1;
5. Life expectancy ≥ 3 months;
6. The results of laboratory examinations at screening must meet all the following criteria:
1. Absolute neutrophil count (ANC) ≥ 1.5×109/L;
2. Absolute white blood cell (WBC) count ≥2.5×109/L;
3. Platelets ≥ 100×109/L;
4. Haemoglobin ≥ 9 g/dL;
5. International normalized ratio (INR) ≤ 1.5 times upper limit of normal (ULN) / or activated partial thromboplastin time (APTT) ≤ 1.5 times ULN (for the test without anticoagulant);
6. INR ≤ 2.5 times ULN / or APTT ≤ 2.5 times ULN (for the test with anticoagulant);
7. Total bilirubin \<= 1.5 x ULN (except participants with Gilbert Syndrome who must have a total bilirubin level of \< 3.0 mg/dL).;
8. AST and ALT ≤ 2.5 times ULN (≤ 5 times ULN for subjects with hepatic cancer or liver metastases); ALT/AST ≤ 3xULN regardless of liver metastasis for cohort G and H only;
9. Albumin ≥ 30g/L;
10. Serum creatinine ≤ 1.5 times ULN, or creatinine clearance rate ≥ 60 ml/min (creatinine clearance rate will be calculated using Cock-croft-Gault Equation);
7. Male and female of childbearing age should agree to take effective contraception measures (refer to Appendix 3. Contraception) from signing the ICF till at least 120 days post the last dose of TST001 and other study drugs except nivolumab; female of childbearing age should agree to take effective contraception measures (refer to Appendix 3. Contraception) from signing the ICF till at least 5 months post the last dose of nivolumab; Serum β-HCG test for women of childbearing age within 72 hours prior to the initial dosing must be negative;
8. (For dose expansion phase only) At least one measurable lesion conforming to per RECIST v1.1;
Exclusion Criteria
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;
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;
10. 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;
11. 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);
12. 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.
13. The subjects who received growth factor, transfusion or other blood products in treatment of anaemia or decreased platelet within 14 days prior to the initial dose;
14. The subjects who experienced clinically significant cardiovascular and cerebrovascular diseases within 6 months before the initial dosing of the investigational drug, including:
i. Myocardial infarction, ii. Unstable angina pectoris, iii. Cerebrovascular accident or iv. Other acute uncontrollable cardiovascular diseases; Clinically significant ventricular arrhythmia history (such as ongoing ventricular tachycardia, ventricular fibrillation and torsade de pointes); New York Heart Association (NYHA) Class III or IV congestive cardiac failure; QTc ≥470ms (female) or QTc ≥450ms (male), or medical history or family history of congenital long-QT syndrome (Naring A, 2012); The subjects with heart rhythm disorders requiring the treatment with antiarrhythmic drugs (The subjects who suffer from atrial fibrillation with heart rate controllable more than 1 month before the initial dosing of the investigational drug will be eligible);
15. The subjects who are known to have dihydropyrimidine dehydrogenase (DPD) deficiency. (Note: DPD deficiency screening should be performed according to local requirement.) (The screening will be performed only in the subjects receiving CAPOX.)
16. Subjects with recent gastrointestinal bleeding as evidenced by hematemesis, hematochezia, or melena in the past 3 months without evidence of resolution documented by endoscopy or colonoscopy;
17. The subjects who have evidenced risk of gastric haemorrhage or gastric perforation will be excluded from the study at the discretion of the investigators;
18. The subjects with documented obstruction pyloric and persistent repeated vomiting defined as ≥ 3 episodes within 24 hours;
19. Documented active colitis within 4 weeks prior to study entry, including infectious colitis, radiation colitis and ischemic colitis.
20. History of ulcerative colitis or Crohn's disease;
21. Uncontrolled diarrhea is present;
22. The subjects who are known to have \> Grade 1 peripheral sensory neuropathy, unless a lack of deep tendon reflexes is the only neurological abnormality;
23. Active infection requiring systematically intravenous antibiotic therapy within 2 weeks prior to dosing;
24. HIV infection history or positive HIV viral test;
25. The subjects who are known to have the history of hepatitis C or chronic active hepatitis B;
Except for:
1. HBV virus carriers or subjects with hepatitis B infection that is stable after medications (HBV-DNA titer should be no more than 1000 copies \[cps\]/mL or 200 IU/mL); Patients who are not currently on viral suppressive therapy may be eligible and should be discussed with the Medical Monitor and if enrolled, antiviral therapy is required throughout study treatment.
2. Subjects with hepatitis C infection that is stable after medications (HCV-RNA test negative);
26. Subjects with active autoimmune disorders requiring systemic immunosuppressive therapy within the past 2 years (Subjects with type 1 diabetes mellitus (TD1M), hypothyroidism requiring hormone replacement therapy only, or skin diseases that do not require systemic treatment are eligible);
27. Any disease requiring systemic treatment with corticosteroids (\> 10 mg/day prednisone or equivalent drugs) or other immunosuppressive drugs for ≤14 days prior to the first dose of the investigational drug, except for:
Adrenal replacement steroids (≤10 mg/day prednisone or equivalent drugs) Topical, ophthalmic, intra-articular, intranasal or inhaled corticosteroids with low systemic absorption Preventive corticosteroids (e.g. prevention of contrast media allergy) for short term (≤ 7 days), or corticosteroids for the treatment of non-autoimmune disorders (e.g. delayed type hypersensitivity caused by contactant);
28. Any conditions that the investigators judge that the patient is not appropriate for PD-1 antibody treatment, including but not limited to a history of interstitial lung disease or non-infectious pneumonia, uncontrollable lung diseases, such as pulmonary fibrosis, active pneumonia, etc. (Cohort G and H);
29. Subjects vaccinated live vaccine within 4 weeks before the first dose of the investigational drug;
30. Pregnant or lactating women;
31. Subject with other conditions (such as psychological, geographic or medical conditions) that do not allow them to follow the study schedule and follow-up procedures. Or the subjects who are unsuitable to be enrolled into the study at the discretion of the investigators.
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Suzhou Transcenta Therapeutics Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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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
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
Countries
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Central Contacts
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Facility Contacts
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Fuyou Zhao
Role: primary
lin Shen
Role: primary
Bangwei Cao
Role: primary
Lin Zhao
Role: primary
Jun Liang
Role: primary
Jun Zhang
Role: primary
Zengqing Guo
Role: primary
Chunmei Shi
Role: primary
Jiayi Li
Role: primary
Yanhong Deng
Role: primary
Kehe Chen
Role: primary
Lin Wang
Role: primary
Qingxia Fan
Role: primary
Yuxian Bai
Role: primary
Ning li
Role: primary
Huiting Xu
Role: primary
Fuxiang Zhou
Role: primary
Xianli Yin
Role: primary
Shan Zeng
Role: primary
Feng Guo
Role: primary
Zhixiang Zhuang
Role: primary
Liang Han
Role: primary
Hua Wang
Role: primary
Ying Cheng
Role: primary
Wei Li
Role: primary
Zhitu Zhu
Role: primary
Jingdong Zhang
Role: primary
Xiujuan Qu
Role: primary
Meili Sun
Role: primary
Jianhua Shi
Role: primary
Xiaochun Zhang
Role: primary
guo weijian
Role: primary
Tianshu Liu
Role: primary
Jin Lu
Role: primary
Dan Cao
Role: primary
Hongli Li
Role: primary
Diansheng Zhong
Role: primary
nong xu
Role: primary
Ying Yuan
Role: primary
Haijun Zhong
Role: primary
Other Identifiers
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TST001-1002
Identifier Type: -
Identifier Source: org_study_id