OncoMatch/Clinical Trials/NCT06385925
A Study of TSN1611 Treating Patients With Advanced Solid Tumors Harboring KRAS G12D Mutation
Is NCT06385925 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies multiple treatments including TSN1611 and TSN1611 for malignant neoplasm.
Treatment: TSN1611 · TSN1611 · TSN1611 · TSN1611 — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Tumor Agnostic
Biomarker criteria
Required: KRAS g12d mutation
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: standard treatment
subjects must be refractory or intolerable to standard treatment, or have no standard treatment available, or the subject is ineligible or declines standard treatment
Cannot have received: KRAS G12D targeted therapy
Prior treatment with KRAS G12D targeted therapy
Cannot have received: systemic anti-cancer treatment
Exception: within 21 days or 5 half-lives (whichever is shorter) prior to the first dose of study drug
Prior systemic anti-cancer treatment within 21 days or 5 half-lives (whichever is shorter) prior to the first dose of study drug
Cannot have received: radical radiation
Exception: within 4 weeks prior to the first dose of study drug
Radical radiation within 4 weeks prior to the first dose of study drug
Cannot have received: palliative radiotherapy
Exception: within 1 week prior to the first dose of study drug
palliative radiotherapy within 1 week prior to the first dose of study drug
Cannot have received: investigational agent
Exception: within 21 days or 5 half-lives, if known (whichever is shorter) prior to the first dose of study drug
Has participated in a study of investigational agent and received the investigational agent within 21 days or 5 half-lives, if known (whichever is shorter) prior to the first dose of study drug
Lab requirements
Kidney function
Liver function
Cardiac function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- MD Anderson Cancer Center · Houston, Texas
- NEXT Oncology · San Antonio, Texas
- NEXT Virginia · Fairfax, Virginia
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06385925 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior KRAS G12D targeted therapy, systemic anti-cancer treatment, radical radiation disqualifies patients from enrollment.
Does this trial require KRAS?
Yes, KRAS g12d mutation is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify