{"preliminary_commentary":{"by_channel":{"x_thread":9,"youtube":1,"podcast":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":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT03075696\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's free public preview; the full report is still bought."},"commentary_summary":null,"name":"NP30179","nct_id":"NCT03075696","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=np30179-nct03075696. 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":1250,"size":"standard","size_rule":"Standard: 151–300 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Participants (single participant cohorts) will receive obinutuzumab pretreatment (Gpt) 1000 milligrams (mg) single dose IV infusion on Day -7 followed by glofitamab IV infusion on Day 1 and Day 8 of Cycle 1. From Cycle 2 onwards, ascending doses of glofitamab will be administered on Day 1 of every 2 week (Q2W) cycle up to Cycle 12 (24 weeks) or until unacceptable toxicity or disease progression. Glofitamab dosing will be initiated at 5 micrograms (mcg) (flat dose) followed by doses of 15 mcg, 45 mcg, 135 mcg, 405 mcg and 810 mcg.","label":"Part I: Dose Escalation","type":"EXPERIMENTAL"},{"description":"In each treatment regimen, participants will receive Gpt 1000 mg IV infusion on Day -7; or 2000 mg either administered on Day -7, or split into two 1000 mg doses on Days -1 and -7. The first glofitamab IV infusion will be given on Day 1 of Cycle 1 and a total of 12 cycles will be administered.\n\nMonotherapy, glofitamab as a single agent: ascending doses of glofitamab administered on Day 1 of Q2W or every 3 week (Q3W) cycle until either the MTD/OBD is defined.\n\nCombination Therapy: From Cycle 2 onwards, a fixed dose of 1000 mg obinutuzumab will be administered via IV infusion in combination with ascending doses of glofitamab on Day 1 of Q3W cycle until either the MTD/OBD is defined.\n\nStep-up dosing: Q3W, participants will receive an initial low dose of glofitamab on Cycle 1 Day 1, followed by a higher dose on Cycle 1 Day 8; the total dose in Cycle 1 will not exceed the previously determined MTD. Higher doses may be explored from Cycle 2 or later cycles.","label":"Part II: Dose Escalation","type":"EXPERIMENTAL"},{"description":"Part III will start once MTD/OBD is defined. Participants will receive Gpt 1000 mg single dose IV infusion on Day -7, followed by glofitamab at a fixed dose regimen or step-up dose regimen on a Q2W or Q3W dosing schedule as determined in Part II. A total of 12 cycles will be administered.\n\nCombination Therapy: From Cycle 2 onwards, a fixed dose of 1000 mg obinutuzumab will be administered via IV infusion in combination with glofitamab at the dosing regimen determined in Part II.","label":"Part III: Dose Expansion","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2029-03-30","type":"ESTIMATED"},"conditions":["Non-Hodgkin's Lymphoma"],"enrollment":{"count":940,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"Glofitamab","otherNames":["RO7082859"],"type":"DRUG"},{"name":"Obinutuzumab","otherNames":["RO5072759, GA101, Gazyva®, Gazyvaro™"],"type":"DRUG"},{"name":"Tocilizumab","otherNames":["Actemra®, Roactemra®"],"type":"DRUG"}],"last_update":"2026-10-28","lead_sponsor":"Hoffmann-La Roche","official_title":"A Multicenter, Open-label, Phase I/II Study to Evaluate the Safety, Efficacy, Tolerability and Pharmacokinetics of Escalating Doses of Glofitamab (RO7082859) as a Single Agent and in Combination With Obinutuzumab Administered After a Fixed, Single Dose Pre-treatment of Obinutuzumab (Gazyva®/Gazyvaro™) in Patients With Relapsed/Refractory B-cell Non-hodgkin's Lymphoma","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE1","PHASE2"],"primary_completion_date":{"date":"2029-03-30","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Part I and II: Percentage of Participants With Dose Limiting Toxicities (DLTs)","timeFrame":"From Baseline up to 4 weeks"},{"measure":"Part I, II and III: Percentage of Participants With Adverse Events (AEs)","timeFrame":"From Baseline up to 90 days after last dose of study drug or until study completion or participant withdrawal (up to 5 years)"},{"measure":"Part II: MTD or OBD of Glofitamab","timeFrame":"From Baseline up to 4 weeks"},{"measure":"Part II: Recommended Phase II Dose (RP2D) of Glofitamab","timeFrame":"From Baseline up to 5 years"},{"measure":"Part III: Complete Response (CR) Rate as Assessed by Independent Review Committee (IRC) According to Standard Non-hodgkin's Lymphoma (NHL) Response Criteria (Lugano Classification)","timeFrame":"From treatment start up to 5 years"},{"measure":"Part I, II and III: Area Under the Serum Concentration Versus Time Curve (AUC) of Glofitamab","timeFrame":"At pre-defined intervals from Cycle 1 Day 1 to Day 71"},{"measure":"Part I, II and III: Maximum Serum Concentration (Cmax) of Glofitamab","timeFrame":"At pre-defined intervals from Cycle 1 Day 1 to Day 198"},{"measure":"Part I, II and III: Minimum Serum Concentration (Cmin) of Glofitamab","timeFrame":"At pre-defined intervals from Cycle 1 Day 1 up to Day 198"},{"measure":"Part I, II and III: Clearance (CL) of Glofitamab","timeFrame":"At pre-defined intervals from Cycle 1 Day 1 to Day 71"},{"measure":"Part I, II and III: Volume of Distribution at Steady-state (Vss) of Glofitamab","timeFrame":"At pre-defined intervals from Cycle 1 Day 1 to Day 71"},{"measure":"Part I, II and III: Half-life (t1/2) of Glofitamab","timeFrame":"At pre-defined intervals from Cycle 1 Day 1 to Day 71"}],"references":[{"citation":"Phillips TJ, Carlo-Stella C, Morschhauser F, Bachy E, Crump M, Trneny M, Bartlett NL, Zaucha J, Wrobel T, Offner F, Humphrey K, Relf J, Filezac de L'Etang A, Carlile DJ, Byrne B, Qayum N, Lundberg L, Dickinson M. Glofitamab in Relapsed/Refractory Mantle Cell Lymphoma: Results From a Phase I/II Study. J Clin Oncol. 2025 Jan 20;43(3):318-328. doi: 10.1200/JCO.23.02470. Epub 2024 Oct 4.","pmid":"39365960","type":"DERIVED"},{"citation":"Dickinson MJ, Carlo-Stella C, Morschhauser F, Bachy E, Corradini P, Iacoboni G, Khan C, Wrobel T, Offner F, Trneny M, Wu SJ, Cartron G, Hertzberg M, Sureda A, Perez-Callejo D, Lundberg L, Relf J, Dixon M, Clark E, Humphrey K, Hutchings M. Glofitamab for Relapsed or Refractory Diffuse Large B-Cell Lymphoma. N Engl J Med. 2022 Dec 15;387(24):2220-2231. doi: 10.1056/NEJMoa2206913. Epub 2022 Dec 11.","pmid":"36507690","type":"DERIVED"},{"citation":"Frances N, Bacac M, Bray-French K, Christen F, Hinton H, Husar E, Quackenbush E, Schafer M, Schick E, Vyver AV, Richter WF. Novel in Vivo and in Vitro Pharmacokinetic/Pharmacodynamic-Based Human Starting Dose Selection for Glofitamab. J Pharm Sci. 2022 Apr;111(4):1208-1218. doi: 10.1016/j.xphs.2021.12.019. Epub 2021 Dec 22.","pmid":"34953862","type":"DERIVED"},{"citation":"Broske AE, Korfi K, Belousov A, Wilson S, Ooi CH, Bolen CR, Canamero M, Alcaide EG, James I, Piccione EC, Carlile DJ, Dimier N, Umana P, Bacac M, Weisser M, Dickinson M. Pharmacodynamics and molecular correlates of response to glofitamab in relapsed/refractory non-Hodgkin lymphoma. Blood Adv. 2022 Feb 8;6(3):1025-1037. doi: 10.1182/bloodadvances.2021005954.","pmid":"34941996","type":"DERIVED"},{"citation":"Hutchings M, Morschhauser F, Iacoboni G, Carlo-Stella C, Offner FC, Sureda A, Salles G, Martinez-Lopez J, Crump M, Thomas DN, Morcos PN, Ferlini C, Broske AE, Belousov A, Bacac M, Dimier N, Carlile DJ, Lundberg L, Perez-Callejo D, Umana P, Moore T, Weisser M, Dickinson MJ. Glofitamab, a Novel, Bivalent CD20-Targeting T-Cell-Engaging Bispecific Antibody, Induces Durable Complete Remissions in Relapsed or Refractory B-Cell Lymphoma: A Phase I Trial. J Clin Oncol. 2021 Jun 20;39(18):1959-1970. doi: 10.1200/JCO.20.03175. Epub 2021 Mar 19.","pmid":"33739857","type":"DERIVED"}],"start_date":{"date":"2017-02-21","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Dose Escalation Study of Glofitamab (RO7082859) as a Single Agent and in Combination With Obinutuzumab, Administered After a Fixed, Single Pre-treatment Dose of Obinutuzumab in Participants With Relapsed/Refractory B-cell Non-hodgkin's Lymphoma","url":"https://clinicaltrials.gov/study/NCT03075696"},"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/np30179-nct03075696"}