drugset / Trial / NCT04396821
A Trial to Evaluate Safety and Tolerability of TST001 in Advanced or Metastatic Solid Tumors
Phase 1/2
Active not recruiting
150 enrolled
Transcenta Therapeutics (Hangzhou) Co., Ltd.
Bristol-Myers Squibb · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is an open label Phase I/IIa, First in Human trial of TST001, a recombinant humanized anti-Claudin 18.2 (CLDN18.2) IgG1 monoclonal antibody as monotherapy or in combination with nivolumab or standard of care. It is being tested against advanced and/or metastatic solid tumors including gastric, gastroesophageal junction, pancreatic cancers.
Timeline
- Start
- 2020-05-28
- Primary completion
- 2027-06-30
- Completion
- 2027-09-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Albumin-Bound Paclitaxel | Unknown | — | — |
| Subject | Gemcitabine | Small molecule | — | — |
| Subject | Leucovorin | Small molecule | — | — |
| Subject | Nivolumab | Monoclonal antibody | — | — |
| Subject | Osemitamab | Monoclonal antibody | 1 mg/kg | Intravenous |
| Subject | Osemitamab | Monoclonal antibody | 2 mg/kg | Intravenous |
| Subject | Osemitamab | Monoclonal antibody | 3 mg/kg | Intravenous |
| Subject | Osemitamab | Monoclonal antibody | 4 mg/kg | Intravenous |
| Subject | Osemitamab | Monoclonal antibody | 6 mg/kg | Intravenous |
| Subject | Oxaliplatin | Small molecule | — | — |
| Subject | fluorouracil | Small molecule | — | — |