A Study Evaluating the Safety, Pharmacokinetics, and Activity of the Combination of Cevostamab and Elranatamab in Participants With Relapsed or Refractory Multiple Myeloma (R/R MM)

Study Purpose

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 dose (RP2D) for the study treatment. The study consists of a safety lead-in stage, and an expansion stage.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- Prior treatment with cevostamab or another agent targeting fragment crystallizable receptor-like 5 (FcRH5) - Prior treatment with elranatamab.

- Prior allogeneic stem cell transplantation (SCT) - Absolute plasma cell count exceeding 500 per milliliter (mL) or 5% of the peripheral blood white cells.

- Diagnosis of Waldenström macroglobulinemia or polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, skin changes (POEMS) syndrome.

- Participants with known history of amyloidosis.

- History of autoimmune disease.

- History of confirmed progressive multifocal leukoencephalopathy.

- Peripheral motor polyneuropathy of prespecified grade.

- Known or suspected chronic cytomegalovirus (CMV) and/or Epstein-Barr virus (EBV) infection.

- Known history of hemophagocytic lymphohistiocytosis (HLH) or macrophage activation syndrome (MAS) - Acute or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.

- Human immunodeficiency virus (HIV) seropositivity.

- History of central nervous system (CNS) myeloma disease.

- Significant cardiovascular disease

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05927571
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Genentech, Inc.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Clinical Trials
Principal Investigator Affiliation	Hoffmann-La Roche
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Australia, Israel, Korea, Republic of
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Relapsed or Refractory Multiple Myeloma

Arms & Interventions

Arms

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

Participants will receive cevostamab, IV, in combination with elranatamab, 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.

Interventions

Drug: - Cevostamab

Cevostamab solution for infusion will be administered as IV as specified in each treatment arm.

Drug: - Elranatamab

Elranatamab solution for injection will be administered SC as specified in each treatment arm.

Drug: - Tocilizumab

Tocilizumab will be used as rescue medication for participants who experience a cytokine release syndrome (CRS) event.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.