{"preliminary_commentary":{"by_channel":{"x_thread":2,"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,"drugs_tested":null,"indication":null,"name":"PRESERVE-006","nct_id":"NCT05682443","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=preserve-006-nct05682443. 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":"PRESERVE-006","arms":[{"description":"Arm 1 receives ONC-392 3 mg/kg, IV infusion, Q4W for up to 13 doses, plus lutetium Lu 177 vipivotide tetraxetan IV infusion, Q6W for up to 6 doses.","label":"Arm 1: ONC-392 low dose plus lutetium Lu 177 vipivotide tetraxetan","type":"EXPERIMENTAL"},{"description":"Arm 2 receives ONC-392 6 mg/kg, IV infusion, Q6W for up to 9 doses, plus lutetium Lu 177 vipivotide tetraxetan IV infusion, Q6W for up to 6 doses.","label":"Arm 2: ONC-392 high dose plus lutetium Lu 177 vipivotide tetraxetan","type":"EXPERIMENTAL"},{"description":"Arm 3 receives lutetium Lu 177 vipivotide tetraxetan, IV infusion, Q6W for up to 6 doses.","label":"Arm 3: lutetium Lu 177 vipivotide tetraxetan","type":"ACTIVE_COMPARATOR"}],"collaborators":["Prostate Cancer Clinical Trials Consortium"],"completion_date":{"date":"2027-11-30","type":"ESTIMATED"},"conditions":["Metastatic Castration-resistant Prostate Cancer"],"enrollment":{"count":148,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"ONC-392 low","otherNames":["A humanized anti-CTLA4 IgG1 monoclonal antibody","Gotistobart"],"type":"DRUG"},{"name":"ONC-392 high","otherNames":["A humanized anti-CTLA4 IgG1 monoclonal antibody","Gotistobart"],"type":"DRUG"},{"name":"lutetium Lu 177 vipivotide tetraxetan","otherNames":["Pluvicto"],"type":"DRUG"}],"last_update":"2026-05-22","lead_sponsor":"OncoC4, Inc.","official_title":"Randomized Study of ONC-392 Plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC) Who Progressed on Androgen Receptor (AR) Pathway Inhibition","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE1","PHASE2"],"primary_completion_date":{"date":"2026-11-30","type":"ESTIMATED"},"primary_outcomes":[{"measure":"DLT (Dose escalation Phase 1)","timeFrame":"40 months"},{"measure":"PSA50 (Dose Expansion Phase 2)","timeFrame":"40 months"},{"measure":"rPFS (Dose Expansion Phase 2)","timeFrame":"40 months"},{"measure":"TEAEs and irAEs (Dose Expansion Phase 2)","timeFrame":"40 months"}],"references":[],"start_date":{"date":"2023-12-11","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"ONC-392 Plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients With mCRPC","url":"https://clinicaltrials.gov/study/NCT05682443"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.1","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/preserve-006-nct05682443"}