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Study identifier: NCT06385925 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

A Study of TSN1611 Treating Patients With Advanced Solid Tumors Harboring KRAS G12D Mutation

Condition: Malignant Neoplasm  ·  Sponsor: Tyligand Pharmaceuticals (Suzhou) Limited

PhasePhase 1/Phase 2
Planned participants440
Who can joinAll sexes, 18 Years to 75 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Tyligand Clinical Trial Info  ·  +86 021-50720081  ·  clinical_trial@tyligand.com

Always discuss trial participation with your own doctor first.

Locations (19)

MD Anderson Cancer CenterHouston, Texas, United StatesRecruiting
NEXT OncologySan Antonio, Texas, United StatesRecruiting
NEXT VirginiaFairfax, Virginia, United StatesRecruiting
Anhui Provincial Cancer HospitalHefei, Anhui, ChinaRecruiting
Beijing Cancer HospitalBeijing, Beijing Municipality, ChinaRecruiting
The First Affiliated Hospital of Guangzhou Medical UniversityGuangzhou, Guangdong, ChinaRecruiting
Hubei Cancer HospitalWuhan, Hubei, ChinaRecruiting
Hunan Cancer HospitalChangsha, Hunan, ChinaRecruiting
The First Affiliated Hospital of Nanchang University - Donghu DistrictNanchang, Jiang, ChinaRecruiting
Linyi Cancer HospitalLinyi, Shandong, ChinaRecruiting
Shanghai Tenth People's HospitalShanghai, Shanghai Municipality, ChinaRecruiting
West China Hospital, Sichuan UniversityChengdu, Sichuan, ChinaRecruiting

+ 7 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06385925