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Clinical trial · no report yet · Phase 1/Phase 2
NCT03075696
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
- NCT03075696 ↗
- Active, not recruiting
- Hoffmann-La Roche
- Standard
We haven't built an HCP commentary report on NCT03075696 (glofitamab, obinutuzumab and 1 more in Non-Hodgkin's Lymphoma) yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Indexed commentary on NCT03075696 so far
Podcasts, YouTube videos and X posts we have indexed that name the trial. It is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this.
| Channel | Indexed | |
|---|---|---|
| X threads | 9 | |
| YouTube | 1 | |
| Podcasts | 1 |
The trial
ClinicalTrials.gov- 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
- Phase
- Phase 1/Phase 2
- Status
- Active, not recruiting
- Conditions
- Non-Hodgkin's Lymphoma
- Interventions
- Glofitamab; Obinutuzumab; Tocilizumab
- Arms
- Part I: Dose Escalation · Experimental
- Part II: Dose Escalation · Experimental
- Part III: Dose Expansion · Experimental
- Enrollment
- 940 (estimated)
- Primary outcomes
- Part I and II: Percentage of Participants With Dose Limiting Toxicities (DLTs)
- Part I, II and III: Percentage of Participants With Adverse Events (AEs)
- Part II: MTD or OBD of Glofitamab
- Part II: Recommended Phase II Dose (RP2D) of Glofitamab
- 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)
- Part I, II and III: Area Under the Serum Concentration Versus Time Curve (AUC) of Glofitamab
- Part I, II and III: Maximum Serum Concentration (Cmax) of Glofitamab
- Part I, II and III: Minimum Serum Concentration (Cmin) of Glofitamab
- Part I, II and III: Clearance (CL) of Glofitamab
- Part I, II and III: Volume of Distribution at Steady-state (Vss) of Glofitamab
- Part I, II and III: Half-life (t1/2) of Glofitamab
- Sponsor
- Hoffmann-La Roche
- Start
- Feb 21, 2017
- Primary completion
- Mar 30, 2029 (estimated)
- Results posted
- No
- Registry record
- NCT03075696 · updated Oct 28, 2026
Publications
linked from the registry- 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. PubMed 39365960
- 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. PubMed 36507690
- 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. PubMed 34953862
- 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. PubMed 34941996
- 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. PubMed 33739857