{"commentary":{"count":16,"free_build_floor":8,"listing_floor":3,"by_channel":{"x_thread":11,"youtube":5},"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":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT05067283\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's public preview; the full report is still bought."},"name":"KANDLELIT-001","nct_id":"NCT05067283","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=kandlelit-001-nct05067283. 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":1250,"size":"standard","size_rule":"Standard: 13–40 commentary sources"},"registry":{"acronym":"KANDLELIT-001","arms":[{"description":"Participants will receive daily oral escalating doses of up to 800 mg of calderasib until progressive disease or discontinuation. Dosing regimen may be adjusted based on safety.","label":"Arm 1","type":"EXPERIMENTAL"},{"description":"Participants will receive calderasib daily oral escalating dose of up to 800 mg plus pembrolizumab given as a 200 mg intravenous infusion once every 21-day cycle up to a total of 35 cycles (up to \\~24 months). Treatment with calderasib will continue until progressive disease or discontinuation. Dosing regimen may be adjusted based on safety.","label":"Arm 2","type":"EXPERIMENTAL"},{"description":"Participants will receive alternate formulation of calderasib until progressive disease or discontinuation. Dosing regimen may be adjusted based on safety.","label":"Arm 3","type":"EXPERIMENTAL"},{"description":"Participants will receive calderasib daily oral dose plus an intravenous infusion of pembrolizumab (200 mg) once every 21-day cycle for up to 35 cycles (up to \\~24 months). Participants will also receive carboplatin (per label) and pemetrexed (per label) once every 21-day cycle for the first 4 cycles.","label":"Arm 4","type":"EXPERIMENTAL"},{"description":"Participants will receive calderasib daily oral dose plus an intravenous infusion of cetuximab (per label) every 2 weeks of each 28-day cycle.","label":"Arm 5","type":"EXPERIMENTAL"},{"description":"Participants will receive calderasib daily oral dose. Additionally, participants receive an intravenous infusion of cetuximab (per label) every 2 weeks of each 28-day cycle, oxaliplatin (per label) for first 6 cycles, and leucovorin (per label) and 5-fluorouracil (per label) once every 14-days.","label":"Arm 6","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2030-02-25","type":"ESTIMATED"},"conditions":["Advanced Solid Tumors"],"enrollment":{"count":830,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"Calderasib","type":"DRUG"},{"name":"Pembrolizumab","type":"BIOLOGICAL"},{"name":"carboplatin","type":"DRUG"},{"name":"pemetrexed","type":"DRUG"},{"name":"cetuximab","type":"BIOLOGICAL"},{"name":"oxaliplatin","type":"DRUG"},{"name":"leucovorin","type":"DRUG"},{"name":"5-fluorouracil","type":"DRUG"}],"last_update":"2026-10-07","lead_sponsor":"Merck Sharp & Dohme LLC","official_title":"A Phase 1, Open-label, Multicenter Study to Assess Safety, Tolerability, PK, and Efficacy of MK-1084 as Monotherapy and as Part of Various Combination Therapies in Participants With KRAS G12C Mutant Advanced Solid Tumors","overall_status":"RECRUITING","phases":["PHASE1"],"primary_completion_date":{"date":"2030-02-25","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Number of Participants Who Experience a Dose-Limiting Toxicity (DLT)","timeFrame":"Up to ~21 days"},{"measure":"Number of Participants Who Experience an Adverse Event (AE)","timeFrame":"Up to ~56 months"},{"measure":"Number of Participants Who Discontinue Study Treatment Due to an AE","timeFrame":"Up to ~56 months"}],"references":[{"citation":"Ma X, Sloman DL, Duggal R, Anderson KD, Ballard JE, Bharathan I, Brynczka C, Gathiaka S, Henderson TJ, Lyons TW, Miller R, Munsell EV, Orth P, Otte RD, Palani A, Rankic DA, Robinson MR, Sather AC, Solban N, Song XS, Wen X, Xu Z, Yang Y, Yang R, Day PJ, Stoeck A, Bennett DJ, Han Y. Discovery of MK-1084: An Orally Bioavailable and Low-Dose KRASG12C Inhibitor. J Med Chem. 2024 Jul 11;67(13):11024-11052. doi: 10.1021/acs.jmedchem.4c00572. Epub 2024 Jun 26.","pmid":"38924388","type":"DERIVED"}],"start_date":{"date":"2021-12-17","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study of Calderasib (MK-1084) in KRAS Mutant Advanced Solid Tumors (MK-1084-001)","url":"https://clinicaltrials.gov/study/NCT05067283"},"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/kandlelit-001-nct05067283"}