{"preliminary_commentary":{"by_channel":{"x_thread":4},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":false},"commentary_summary":null,"drugs_tested":[["HRS-4642"]],"indication":"advanced KRAS G12D-mutant solid tumors","name":"NCT05533463","nct_id":"NCT05533463","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct05533463. The price is an estimate of verified statements from the commentary indexed so far. Final coverage is set when the report is built. You never pay more than quoted: if the report is delivered at a smaller size, you pay that size's price, and anything paid above it is refunded. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_rule":"Never more than quoted: the buyer pays the smaller of price_usd and the price the delivered edition is sold at.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"In Dose Escalation:\n\nHRS-4642 will be injected QW. Six dose levels are preset.\n\nIn Dose Expansion:\n\n1 to 2 dose cohorts will be selected for dose expansion stage.\n\nIn Indication Expansion:\n\nEnrollment into the dose expansion cohorts may be from any eligible solid tumor type.","label":"HRS-4642","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2025-12-30","type":"ESTIMATED"},"conditions":["Advanced KRAS G12D Mutant Solid Tumors"],"enrollment":{"count":102,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"HRS-4642","otherNames":[],"type":"DRUG"}],"last_update":"2025-09-08","lead_sponsor":"Jiangsu HengRui Medicine Co., Ltd.","official_title":"Phase I Study to Evaluate the Safety ,Tolerability, and Pharmacokinetics of HRS-4642 in Patients With Advanced Solid Tumors Harboring KRAS G12D Mutation","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE1"],"primary_completion_date":{"date":"2024-06-25","type":"ACTUAL"},"primary_outcomes":[{"measure":"Safety endpoints: adverse events(AEs), serious adverse events（SAEs）.","timeFrame":"24 months"},{"measure":"Dose Limited Toxicity(DLT)","timeFrame":"from day 1 to Day 21"},{"measure":"Maximum tolerated dose (MTD)","timeFrame":"From Day 1 to Day 21"},{"measure":"RP2D","timeFrame":"24 months"}],"references":[{"citation":"Zhou C, Li C, Luo L, Li X, Jia K, He N, Mao S, Wang W, Shao C, Liu X, Huang K, Yu Y, Cai X, Chen Y, Dai Z, Li W, Yu J, Li J, Shen F, Wang Z, He F, Sun X, Mao R, Shi W, Zhang J, Jiang T, Zhang Z, Li F, Ren S. Anti-tumor efficacy of HRS-4642 and its potential combination with proteasome inhibition in KRAS G12D-mutant cancer. Cancer Cell. 2024 Jul 8;42(7):1286-1300.e8. doi: 10.1016/j.ccell.2024.06.001. Epub 2024 Jun 27.","pmid":"38942026","type":"DERIVED"}],"start_date":{"date":"2022-09-21","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Phase I Study of HRS-4642 in Patients With Advanced Solid Tumors Harboring KRAS G12D Mutation","url":"https://clinicaltrials.gov/study/NCT05533463"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.2","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/nct05533463"}