drugset / Trial / NCT06385925
A Study of TSN1611 Treating Patients With Advanced Solid Tumors Harboring KRAS G12D Mutation
Non-randomizedSequentialOpen-labelTreatment
Summary
The study is a first-in-human (FIH), open-label, multi-center phase 1/2 study of TSN1611 in subjects with KRAS G12D mutant advanced solid tumors. This study will consist of a phase 1 dose escalation part and phase 2 dose expansion part. This study will evaluate the efficacy of TSN1611 at RP2D(s) through ORR using RECIST version 1.1, and determine and confirm the MTD/RP2D for TSN1611 in combination with cetuximab, in combination with cetuximab and mFOLFOX6, in combination with gemcitabine and albumin-bound paclitaxel in subjects with selected solid tumors.
Timeline
- Start
- 2024-04-29
- Primary completion
- 2026-10-30
- Completion
- 2027-04-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Background | Paclitaxel | Small molecule | — | Oral |
| Background | Cetuximab | Monoclonal antibody | 500 mg/m2 | Intravenous |
| Background | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |
| Background | Leucovorin | Small molecule | — | — |
| Background | Oxaliplatin | Small molecule | — | — |
| Background | Paclitaxel | Small molecule | 125 mg/m2 | Intravenous |
| Background | fluorouracil | Small molecule | — | — |