Actively Recruiting
A Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TST001 in Advanced or Metastatic Solid Tumors
Led by Suzhou Transcenta Therapeutics Co., Ltd. · Updated on 2025-12-19
320
Participants Needed
40
Research Sites
328 weeks
Total Duration
On this page
Sponsors
S
Suzhou Transcenta Therapeutics Co., Ltd.
Lead Sponsor
B
Bristol-Myers Squibb
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
A Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TST001 in Advanced or Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and willing to follow study procedures
- Male or female aged 18 years or older
- Histologically confirmed locally unresectable advanced or metastatic solid tumors
- For monotherapy dose expansion: positive CLDN18.2 expression in tumor tissue confirmed by central laboratory
- ECOG performance status of 0-1
- Life expectancy of at least 3 months
- Laboratory test results meeting specified blood counts, liver and kidney function, and coagulation criteria
- Agreement to use effective contraception during and after the study as specified
- For dose expansion phase: at least one measurable lesion per RECIST v1.1
- Additional cohort-specific criteria related to prior treatments and cancer types as detailed in the protocol
You will not qualify if you...
- Prior systemic chemotherapy for combination therapy cohorts C, G, and D unless completed neoadjuvant or adjuvant chemotherapy at least 6 months before dosing
- Radiotherapy within 4 weeks prior to initial dosing (except certain resolved bone metastases treatment)
- Other systemic anti-tumor therapies within 4 weeks or 5 half-lives prior to dosing
- Major surgery within 8 weeks prior to dosing or unhealed wounds or trauma
- Prior targeted CLDN18.2 therapy
- Serious allergic reactions or intolerance to study drugs or components
- Presence of symptomatic brain or leptomeningeal metastases
- Uncontrolled body cavity effusions requiring treatment
- Concurrent malignant tumors within 3 years except specified types
- Unresolved adverse reactions from prior treatments above Grade 1 (except alopecia and anemia)
- Recent use of growth factors or blood products for anemia or low platelets
- Significant cardiovascular or cerebrovascular disease within 6 months
- Known dihydropyrimidine dehydrogenase deficiency (for CAPOX recipients)
- Recent gastrointestinal bleeding or risk of gastric hemorrhage or perforation
- Documented active colitis or history of ulcerative colitis or Crohn's disease
- Uncontrolled diarrhea
- Greater than Grade 1 peripheral sensory neuropathy (unless limited to deep tendon reflex absence)
- Active infection needing intravenous antibiotics within 2 weeks
- HIV infection or positive test
- History of hepatitis C or uncontrolled hepatitis B infection
- Active autoimmune disorders requiring systemic immunosuppressive therapy within 2 years
- Recent systemic corticosteroid or immunosuppressive treatment above specified doses
- Conditions unsuitable for PD-1 antibody treatment (for cohorts G and H)
- Live vaccination within 4 weeks before dosing
- Pregnant or breastfeeding women
- Other conditions limiting ability to comply with study or follow-up procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 40 locations
1
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
Actively Recruiting
2
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100036
Actively Recruiting
3
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Actively Recruiting
4
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Not Yet Recruiting
5
Peking University International Hospital
Beijing, Beijing Municipality, China
Not Yet Recruiting
6
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Actively Recruiting
7
Fujian Cancer Hospital
Fuzhou, Fujian, China
Actively Recruiting
8
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Actively Recruiting
9
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Actively Recruiting
10
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Actively Recruiting
11
The People's Hospital of Guangxi Zhuang Autonomous Region
Guangxi, Guangxi, China
Not Yet Recruiting
12
Hainan Provincial People's Hospital
Haikou, Hainan, China
Actively Recruiting
13
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Heibei, China
Actively Recruiting
14
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Actively Recruiting
15
Henan Cancer Hospital
Zhengzhou, Henan, China
Actively Recruiting
16
Hubei Cancer Hospital
Wuhan, Hubei, China
Actively Recruiting
17
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
Actively Recruiting
18
Hunan Cancer Hospital
Changsha, Hunan, China
Actively Recruiting
19
Xiangya Hospital, Central South University
Changsha, Hunan, China
Actively Recruiting
20
Suzhou Municipal Hospital
Suzhou, Jiangsu, China
Actively Recruiting
21
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Actively Recruiting
22
Xuzhou Central Hospital
Xuzhou, Jiangsu, China
Actively Recruiting
23
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Actively Recruiting
24
Jilin Cancer Hospital
Changchun, Jilin, China
Actively Recruiting
25
The First Hospital of Jilin University
Changchun, Jilin, China
Actively Recruiting
26
The First Affiliated Hospital of Jinzhou Medical University
Jinzhou, Liaoning, China
Actively Recruiting
27
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, China
Actively Recruiting
28
The First Hospital of China Medical University
Shenyang, Liaoning, China
Actively Recruiting
29
Jinan Central Hospital
Jinan, Shandong, China
Actively Recruiting
30
Linyi Cancer Hospital
Linyi, Shandong, China
Actively Recruiting
31
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Actively Recruiting
32
Fudan University Shanghai Cance Center
Shanghai, Shanghai Municipality, China
Actively Recruiting
33
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, China
Actively Recruiting
34
Sichuan Cancer Hospital
Chengdu, Sichuan, China
Actively Recruiting
35
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Actively Recruiting
36
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
Actively Recruiting
37
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
Actively Recruiting
38
First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China
Actively Recruiting
39
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Actively Recruiting
40
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
Q
Qian Wu
CONTACT
H
Henry Mao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
10
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