{"preliminary_commentary":{"by_channel":{"x_thread":3},"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":"NCT04471727","nct_id":"NCT04471727","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct04471727. 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":"Participants will receive gocatamig once weekly (Q1W) via intravenous (IV) infusion during each 21-day cycle. Dose escalation may continue until one or more RDEs are identified, participant discontinuation or the Sponsor decides to stop enrollment.","label":"Gocatamig monotherapy dose escalation with 1 week dosing interval","type":"EXPERIMENTAL"},{"description":"Participants will receive gocatamig via IV infusion once every 2 weeks (Q2W) of a 28-day cycle. Dose escalation may continue until one or more RDEs are identified, participant discontinuation, or the Sponsor decides to stop enrollment.","label":"Gocatamig monotherapy dose escalation with 2 week dosing interval","type":"EXPERIMENTAL"},{"description":"Participants will receive gocatamig via IV infusion once every 3 weeks (Q3W) of a 21-day cycle. Dose escalation may continue until one or more RDEs are identified, participant discontinuation, or the Sponsor decides to stop enrollment.","label":"Gocatamig monotherapy dose escalation with 3 week dosing interval","type":"EXPERIMENTAL"},{"description":"Small cell lung cancer (SCLC) participants will receive gocatamig via IV infusion Q2W during each 28-day cycle and Atezolizumab via IV infusion every 4 weeks (Q4W) on Day 1 of each 28-day cycle. Dose escalation may continue until one or more RDEs are identified, participant discontinuation, or the Sponsor decides to stop enrollment.","label":"Gocatamig dose escalation with atezolizumab","type":"EXPERIMENTAL"},{"description":"SCLC participants will receive gocatamig via IV infusion Q2W during each 42-day cycle and I-DXd via IV infusion Q3W on Day 1 and Day 22 of each 42-day cycle. Dose escalation may continue until one or more RDEs are identified, participant discontinuation, or the Sponsor decides to stop enrollment.","label":"Gocatamig dose escalation in combination with I-DXd","type":"EXPERIMENTAL"}],"collaborators":["Daiichi Sankyo"],"completion_date":{"date":"2028-01-28","type":"ESTIMATED"},"conditions":["Small-Cell Lung Cancer","Neuroendocrine Carcinoma"],"enrollment":{"count":232,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"Gocatamig","otherNames":["HPN328","MK-6070"],"type":"BIOLOGICAL"},{"name":"Atezolizumab","otherNames":[],"type":"BIOLOGICAL"},{"name":"Ifinatamab Deruxtecan (I-DXd)","otherNames":["DS-7300a","MK-2400"],"type":"BIOLOGICAL"}],"last_update":"2026-02-24","lead_sponsor":"Harpoon Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)","official_title":"A Phase 1/2 Open-label, Multicenter, Dose Escalation and Dose Expansion Study of the Safety, Tolerability, and Pharmacokinetics of HPN328 Monotherapy and HPN328 With Atezolizumab or Ifinatamab Deruxtecan (I-DXd) in Patients With Advanced Cancers Associated With Expression of Delta-like Canonical Notch Ligand 3 (DLL3).","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE1","PHASE2"],"primary_completion_date":{"date":"2028-01-28","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Percentage of participants who experience an adverse event","timeFrame":"Up to ~4 years"},{"measure":"Percentage of participants who discontinue due to an adverse event","timeFrame":"Up to ~4 years"},{"measure":"Number of participants with dose limiting toxicity (DLT) following treatment with HPN328 as monotherapy or in combination with atezolizumab or I-DXd","timeFrame":"Up to ~4 years"},{"measure":"Maximum concentration (Cmax) of Gocatamig","timeFrame":"At designated time points up to ~4 years"},{"measure":"Cmax of Atezolizumab","timeFrame":"At designated time points up to ~4 years"},{"measure":"Cmax of I-DXd","timeFrame":"At designated time points up to ~4 years"},{"measure":"Time to maximum concentration (Tmax) of Gocatamig","timeFrame":"At designated time points up to ~4 years"},{"measure":"Tmax of atezolizumab","timeFrame":"At designated time points up to ~4 years"},{"measure":"Tmax of I-DXd","timeFrame":"At designated time points up to ~4 years"},{"measure":"Area under the concentration-time curve over the dosing interval t (AUCt) of Gocatamig","timeFrame":"At designated time points up to ~4 years"},{"measure":"AUCt of atezolizumab","timeFrame":"At designated time points up to ~4 years"},{"measure":"AUCt of I-DXd","timeFrame":"At designated time points up to ~4 years"},{"measure":"Area under the concentration-time curve extrapolated to infinity (AUCinf) of Gocatamig","timeFrame":"At designated time points up to ~4 years"},{"measure":"AUCinf of atezolizumab","timeFrame":"At designated time points up to ~4 years"},{"measure":"AUCinf of I-DXd","timeFrame":"At designated time points up to ~4 years"},{"measure":"Terminal half-life (t1/2) of Gocatamig","timeFrame":"At designated time points up to ~4 years"},{"measure":"t1/2 of atezolizumab","timeFrame":"At designated time points up to ~4 years"},{"measure":"t1/2 of I-DXd","timeFrame":"At designated time points up to ~4 years"},{"measure":"Single dose clearance (CL) of Gocatamig","timeFrame":"At designated time points up to ~4 years"},{"measure":"CL of atezolizumab","timeFrame":"At designated time points up to ~4 years"},{"measure":"CL of I-DXd","timeFrame":"At designated time points up to ~4 years"},{"measure":"Steady state maximum concentration (Cmax,ss) of Gocatamig","timeFrame":"At designated time points up to ~4 years"},{"measure":"Cmax,ss of atezolizumab","timeFrame":"At designated time points up to ~4 years"},{"measure":"Cmax,ss of I-DXd","timeFrame":"At designated time points up to ~4 years"},{"measure":"Steady state Ctrough (Ctrough,ss) of Gocatamig","timeFrame":"At designated time points up to ~4 years"},{"measure":"Ctrough,ss of atezolizumab","timeFrame":"At designated time points up to ~4 years"},{"measure":"Ctrough,ss of I-DXd","timeFrame":"At designated time points up to ~4 years"},{"measure":"Steady state time to maximum concentration (Tmax,ss) of Gocatamig","timeFrame":"At designated time points up to ~4 years"},{"measure":"Tmax,ss of atezolizumab","timeFrame":"At designated time points up to ~4 years"},{"measure":"Tmax,ss of I-DXd","timeFrame":"At designated time points up to ~4 years"},{"measure":"Area under the steady state concentration-time curve over dosing interval t (AUCt,ss) of Gocatamig","timeFrame":"At designated time points up to ~4 years"},{"measure":"AUCt,ss of atezolizumab","timeFrame":"At designated time points up to ~4 years"},{"measure":"AUCt,ss of I-DXd","timeFrame":"At designated time points up to ~4 years"},{"measure":"Steady state t1/2 (t1/2,ss) of Gocatamig","timeFrame":"At designated time points up to ~4 years"},{"measure":"t1/2,ss of Gocatamig with atezolizumab","timeFrame":"At designated time points up to ~4 years"},{"measure":"t1/2,ss of IDXd","timeFrame":"At designated time points up to ~4 years"},{"measure":"Steady state CL (CL,ss) of Gocatamig","timeFrame":"At designated time points up to ~4 years"},{"measure":"CL,ss of Gocatamig with atezolizumab","timeFrame":"At designated time points up to ~4 years"},{"measure":"CL,ss of I-DXd","timeFrame":"At designated time points up to ~4 years"},{"measure":"Steady state volume of distribution (V,ss) of Gocatamig","timeFrame":"At designated time points up to ~4 years"},{"measure":"V,ss of atezolizumab","timeFrame":"At designated time points up to ~4 years"},{"measure":"V,ss of I-DXd","timeFrame":"At designated time points up to ~4 years"},{"measure":"Steady state accumulation ratio (AC) of Gocatamig","timeFrame":"At designated time points up to ~4 years"},{"measure":"AC of atezolizumab","timeFrame":"At designated time points up to ~4 years"},{"measure":"AC of I-DXd","timeFrame":"At designated time points up to ~4 years"}],"references":[],"start_date":{"date":"2020-12-14","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study in Participants With Advanced Cancers Associated With Expression of DLL3 (MK-6070-001/HPN328-4001)","url":"https://clinicaltrials.gov/study/NCT04471727"},"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/nct04471727"}