A Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TST
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 thera
| Condition(s) | Advanced Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: The subjects who meet all inclusion criteria can be enrolled into the trial: 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 th |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Suzhou Transcenta Therapeutics Co., Ltd. |
| Locations | Bengbu, Anhui, China; Beijing, Beijing Municipality, China; Beijing, Beijing Municipality, China; Beijing, Beijing Municipality, China; Beijing, Beijing Municipality, China; Chongqing, Chongqing Municipality, China (+34 more sites) |
| Start date | 2020-08-13 |
| NCT ID | NCT04495296 |
| Official listing | https://clinicaltrials.gov/study/NCT04495296 |