OncoMatch/Clinical Trials/NCT06385925
A Study of TSN1611 Treating Patients With Advanced Solid Tumors Harboring KRAS G12D Mutation
Is NCT06385925 recruiting? Yes, currently enrolling (May 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
Cancer type
Tumor Agnostic
Biomarker criteria
Required: KRAS g12d mutation
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
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 →
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