A Study of TSN1611 Treating Patients With Advanced Solid Tumors Harboring KRAS G12D Mutation
NCT06385925
This study is recruiting at 3 US sites in 2 states, according to its ClinicalTrials.gov record last updated .
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.
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Malignant Neoplasm
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Phase 1/2
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Sponsor
- Tyligand Pharmaceuticals (Suzhou) Limited
- Last updated on ClinicalTrials.gov
- April 24, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
Texas · 2
- MD Anderson Cancer Center · Houston, TX
- NEXT Oncology · San Antonio, TX
Virginia · 1
- NEXT Virginia · Fairfax, VA
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.