An Open-Label, Multicenter, Phase Ib Trial Evaluating the Safety, Pharmacokinetics, and Activity of the Combination of Cevostamab and Elranatamab in Patients With Relapsed or Refractory Multiple Myeloma
Status: Recruiting
Location: See all (9) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
The purpose of the study is to evaluate safety and tolerability of the combination of cevostamab plus elranatamab and also determine the recommended Phase II regimen (RP2R) for the study treatment. The study consists of a safety lead-in stage, and an expansion stage.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
• Diagnosis of R/R MM per IMWG criteria
• For female participants of childbearing potential: agreement to remain abstinent or use contraception
• For male participants: agreement to remain abstinent or use a condom
Locations
Other Locations
Australia
Royal Prince Alfred Hospital
RECRUITING
Camperdown
The Alfred Hospital
RECRUITING
Prahan
Calvary Mater Newcastle
RECRUITING
Waratah
Israel
Rambam Health Care Campus
RECRUITING
Haifa
Sheba Medical Center - PPDS
RECRUITING
Ramat Gan
Tel Aviv Sourasky Medical Center PPDS
RECRUITING
Tel Aviv
Republic of Korea
The Catholic University of Korea - Seoul St. Mary's Hospital (Kangnam St. Mary's Hospital)
RECRUITING
Seocho
Samsung Medical Center - PPDS
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Contact Information
Primary
GO43979 https://forpatients.roche.com/
global-roche-genentech-trials@gene.com
888-662-6728 (U.S. Only)
Time Frame
Start Date: 2023-08-10
Estimated Completion Date: 2027-07-31
Participants
Target number of participants: 120
Treatments
Experimental: Safety Lead-In Cohort
Participants will receive cevostamab, intravenously (IV), in combination with elranatamab, subcutaneously (SC), with step-up dosing of each drug in pre-phase following which they will receive elranatamab, at the assigned dose as a SC injection until disease progression or unacceptable toxicity. Participants will also receive cevostamab at the assigned dose as IV infusion until disease progression or unacceptable toxicity or up to 1 year on treatment, whichever occurs first.
Experimental: Dose Expansion Cohort (Combined Therapy)
Participants will receive cevostamab, IV, in combination with elranatamab, SC, with step-up dosing in pre-phase following which they will receive elranatamab, at the assigned dose as a SC injection until disease progression or unacceptable toxicity. Participants will also receive cevostamab at the assigned dose as IV infusion until disease progression or unacceptable toxicity or up to 1 year on treatment, whichever occurs first.
Experimental: Dose Expansion Cohort (Monotherapy)
Participants will receive elranatamab SC, with step-up dosing in pre-phase following which they will receive elranatamab, at the assigned dose as a SC injection until disease progression or unacceptable toxicity.
Related Therapeutic Areas
Sponsors
Leads: Genentech, Inc.