Status: Recruiting
A Study of TSN1611 Treating Patients With Advanced Solid Tumors Harboring KRAS G12D Mutation
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.
Participants needed: 440
Trial details
Phase: Phase 1, Phase 2Age: 18-75Biological sex: AllType: InterventionalSponsor: Tyligand Pharmaceuticals (Suzhou) LimitedUpdated: Apr 24, 2026Locations: 19
Eligibility criteria
The subject fully understands the requirements of the study and voluntarily sign... [+3]
Leptomeningeal disease or Active central nervous system (CNS) metastases. [+8]