{"commentary":{"count":4,"free_build_floor":8,"listing_floor":3,"by_channel":{"x_thread":4},"note":"Indexed podcasts, YouTube videos and X posts that name this trial. A report screens them, searches for more and cites what clinicians said when it is built."},"free_build":{"available":false},"name":"NCT06385925","nct_id":"NCT06385925","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct06385925. The price is fixed at order. We build the report after the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":750,"size":"focused","size_rule":"Focused: 1–12 commentary sources"},"registry":{"acronym":null,"arms":[{"description":"The phase 1 part will evaluate the prespecified sequential dose levels of TSN1611 in subjects with KRAS G12D mutant advanced solid tumors to determine the recommended dose of TSN1611 for further investigation.","label":"Phase 1: Dose-finding/evaluation of TSN1611 monotherapy","type":"EXPERIMENTAL"},{"description":"Phase 2 part will evaluate the efficacy and safety of TSN1611 as monotherapy at the recommended dose level in separate groups of patients with pancreatic cancer, colorectal cancer, non-small cell lung cancer, or other solid tumors, harboring KRAS G12D mutations.","label":"Phase 2: Dose expansion of TSN1611 monotherapy","type":"EXPERIMENTAL"},{"description":"Cohort A: TSN1611 combined with cetuximab treating subjects with advanced solid tumors harboring KRAS G12D mutation:","label":"Dose of Phase 1b/2 part of TSN1611 combination therapy-Cohort A","type":"EXPERIMENTAL"},{"description":"Cohort B: TSN1611 combined with GnP regimen (i.e., gemcitabine and nab-paclitaxel) treating subjects with advanced PDAC with KRAS G12D mutation who received no prior systemic treatment in the advanced setting.","label":"Dose of Phase 1b/2 part of TSN1611 combination therapy-Cohort B","type":"EXPERIMENTAL"},{"description":"Cohort C: TSN1611 combined with cetuximab and mFOLFOX6 regimen (i.e., fluorouracil, leucovorin, oxaliplatin) treating subjects with advanced CRC with KRAS G12D mutation who received no prior systemic treatment in the advanced setting.","label":"Dose of Phase 1b/2 part of TSN1611 combination therapy-Cohort C","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2027-04-30","type":"ESTIMATED"},"conditions":["Malignant Neoplasm"],"enrollment":{"count":440,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"TSN1611","type":"DRUG"},{"name":"TSN1611","type":"DRUG"},{"name":"TSN1611","type":"DRUG"},{"name":"TSN1611","type":"DRUG"}],"last_update":"2026-04-24","lead_sponsor":"Tyligand Pharmaceuticals (Suzhou) Limited","official_title":"Phase 1/2 Study of TSN1611 in Subjects With Advanced Solid Tumors Harboring KRAS G12D Mutation","overall_status":"RECRUITING","phases":["PHASE1","PHASE2"],"primary_completion_date":{"date":"2026-10-30","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Dose limiting toxicities (DLTs) in phase 1 part","timeFrame":"21 days"},{"measure":"Objective response rate (ORR) in phase 2 part","timeFrame":"Up to 3 years"}],"references":[],"start_date":{"date":"2024-04-29","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study of TSN1611 Treating Patients With Advanced Solid Tumors Harboring KRAS G12D Mutation","url":"https://clinicaltrials.gov/study/NCT06385925"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"2.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/nct06385925"}