{"preliminary_commentary":{"by_channel":{"youtube":1,"x_thread":1,"bluesky_thread":1},"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,"name":"KEYNOTE-F58 (MK-3475-F58)","nct_id":"NCT05482893","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=keynote-f58-mk-3475-f58-nct05482893. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. 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_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"An accelerated titration design will be employed for early dose levels, followed by the standard 3+3 design at higher dose levels.","label":"Dose Escalation","type":"EXPERIMENTAL"},{"description":"One or more indications (GC/GEJC, BTC, CRC or PDAC) and/or lines of treatment may be selected for dose expansion at two dose levels (RDE1 and RDE2).","label":"Dose Expansion","type":"EXPERIMENTAL"},{"description":"Part C, substudy C1: patients with 2L m/a GC/GEJ-C will receive Spevatamig (PT886) in combination with Paclitaxel.\n\nPart C, substudy C2: patients with 1L m/a PDAC will receive Spevatamig (PT886) in combination with Gemcitabine plus nab-Paclitaxel (Abraxane).\n\nPart C, substudy C3: patients with 1L m/a PDAC will receive Spevatamig (PT886) in combination with Gemcitabine plus FOLFIRINOX/mFFX or NALIRIFOX.\n\nPart C, substudy C4: patients with 2L BTC will receive PT886 in combination with SOC chemotherapy mFOLFOX6.\n\nPart C, substudy C5: patients with 3L CRC patients will receive PT886 in combination with SOC chemotherapy TAS-102.\n\nPart C, substudy C6: patients with 3L CRC patients will receive PT886 in combination with bevacizumab.\n\nPart C, substudy C7: patients with 3L CRC patients will receive PT886 in combination with SOC chemotherapy TAS-102 and bevacizumab.","label":"Combination Expansion with Chemotherapy or Targeted Therapy","type":"EXPERIMENTAL"},{"description":"Part D, substudy D2: patients with 1L BTC will receive Spevatamig (PT886) in combination with KEYTRUDA® (pembrolizumab) and standard of care chemotherapy GemCis.\n\nPart D, substudy D3: patients with 2L or 3L m/a GC/GEJ-C will receive Spevatamig (PT886) in combination with KEYTRUDA® (pembrolizumab).\n\nPart D, substudy D4: patients with 1L HER2 negative m/a GC/GEJ-C will receive Spevatamig (PT886) in combination with SOC chemotherapy and KEYTRUDA® (pembrolizumab).","label":"Combination Expansion with KEYTRUDA® (pembrolizumab)","type":"EXPERIMENTAL"}],"collaborators":["Merck Sharp & Dohme LLC"],"completion_date":{"date":"2028-04","type":"ESTIMATED"},"conditions":["Gastric or Gastroesophageal Junction Adenocarcinoma","Pancreatic Ductal Adenocarcinoma","Biliary Tract Cancer (BTC)","Colorectal Cancer"],"enrollment":{"count":350,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"Spevatamig (PT886)","otherNames":[],"type":"DRUG"},{"name":"Paclitaxel","otherNames":[],"type":"DRUG"},{"name":"Gemcitabine","otherNames":[],"type":"DRUG"},{"name":"Abraxane","otherNames":[],"type":"DRUG"},{"name":"KEYTRUDA® (pembrolizumab)","otherNames":[],"type":"DRUG"},{"name":"FOLFOX","otherNames":[],"type":"DRUG"},{"name":"CAPOX","otherNames":[],"type":"DRUG"},{"name":"FOLFIRINOX","otherNames":[],"type":"DRUG"},{"name":"TAS 102","otherNames":[],"type":"DRUG"},{"name":"Bevacizumab","otherNames":[],"type":"DRUG"},{"name":"Gemcitabine Combined With Cisplatin","otherNames":[],"type":"DRUG"},{"name":"NALIRIFOX","otherNames":[],"type":"DRUG"}],"last_update":"2026-09-28","lead_sponsor":"Phanes Therapeutics","official_title":"A Phase 1/2, Open-Label, Dose Escalation and Expansion Study With PT886 Followed by a Multi-cohorT Study in Patients With Advanced Gastrointestinal Cancers, Including GastrIc, Gastroesophageal JuNction, Pancreatic Ductal or Biliary Tract AdEnocarcinomas of PT886, in Combination With ChemotherApy, Targeted Therapy, and/or an Immune ChecKpoint Inhibitor. The TWINPEAK Study","overall_status":"RECRUITING","phases":["PHASE1","PHASE2"],"primary_completion_date":{"date":"2027-12","type":"ESTIMATED"},"primary_outcomes":[{"measure":"To evaluate the safety and tolerability of Spevatamig (PT886) as monotherapy and in each individual combination substudy.","timeFrame":"Through study completion, an average of 2 years"},{"measure":"To evaluate anti-tumor activity of PT886 as assessed by ORR, in Spevatamig (PT886) monotherapy and in each combination substudy.","timeFrame":"Through study completion."},{"measure":"To determine the recommended dose for expansion of Spevatamig (PT886) monotherapy.","timeFrame":"Through study completion."}],"references":[],"start_date":{"date":"2023-03-15","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Spevatamig (PT886) as Monotherapy or in Combination With Chemo and/or Targeted Therapy and/or ICI, for the Treatment of Patients With Advanced Gastrointestinal Cancers, Including Gastric, Gastroesophageal Junction, Pancreatic Ductal or Biliary Tract Carcinomas (the TWINPEAK Study)","url":"https://clinicaltrials.gov/study/NCT05482893"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/keynote-f58-mk-3475-f58-nct05482893"}