Healthy Volunteers, Relapsed Multiple Myeloma, Refractory Multiple Myeloma
Conditions
Brief summary
Part A: The purpose of Part A of this study is to evaluate the safety, pharmacokinetics, and pharmacodynamics of RO7875913 in healthy participants. Part B: The purpose of Part B of this study is to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of RO7875913 administered in combination with the T cell-engaging bispecific antibody (TCB) cevostamab in participants with relapsed or refractory (R/R) multiple myeloma (MM).
Interventions
DRUGRO7875913
Participants will receive RO7875913 as per the schedule described in the protocol.
DRUGPlacebo
Participants will receive placebo as per the schedule described in the protocol.
DRUGCevostamab
Participants will receive cevostamab as per the schedule described in the protocol
Sponsors
Genentech, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Part B is open label
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
General: * Agreement to adhere to the contraception requirements Part A: * Body weight \> 40 kilogram (kg) with a body mass index of 18-30 kg per meter square (kg/m\^2) Part B: * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Life expectancy of at least 12 weeks * Agreement to provide bone marrow biopsy and aspirate samples
Exclusion criteria
General: * Treatment with any vaccine within 4 weeks prior to initiation of study drug, or vaccination scheduled to occur during the study * History or current cardiovascular or pulmonary disease that may limit the ability to respond to systemic infusion/injection reactions * Positive test result for hepatitis B surface antigen, hepatitis C virus (HCV), or human immunodeficiency virus (HIV) antibody screen * History of any malignancy * Major surgical procedure within 28 days prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study * History or clinical manifestations of significant metabolic, hepatic, renal, pulmonary, cardiovascular, hematologic, gastrointestinal, urologic, neurologic, or psychiatric disorders * Known allergy or hypersensitivity to any component of the RO7875913 formulation Part A: * Treatment with investigational biologic therapy (or blinded comparator) within 90 days or 5 drug elimination half-lives, whichever is longer, prior to initiation of study drug * Treatment with investigational non-biologic therapy (or blinded comparator) within 28 days or 5 drug elimination half-lives, whichever is longer, prior to initiation of study drug * Clinically apparent or familial history of autoimmune disease Part B: * Treatment with any systemic chemotherapeutic agent, or treatment with any other anti-cancer agent (investigational or otherwise) within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to first dose of study treatment * Treatment with any immunosuppressive medication within 2 weeks prior to first dose of study treatment * Absolute plasma cell count exceeding 500/mL or 5% of the peripheral blood white cells
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A: Percentage of Participants with Adverse Events (AEs) | Up to approximately 3 months |
| Part B: Percentage of Participants with Adverse Events (AEs) | Up to approximately 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Part A: Serum concentration of RO7875913 | Up to Day 76 |
| Part A: Percentage of Participants with Anti-Drug Antibodies (ADAs) to RO7875913 at Baseline and with ADAs to RO7875913 During the Treatment Period | Baseline, Up to Day 76 |
| Part A: Recommended Phase II Dose (RP2D) of RO7875913 | Up to approximately 3 months |
| Part A: Observed Value of Pharmacodynamic Markers | Baseline, up to approximately 3 months |
| Part B: Serum Concentration of RO7875913 | Up to approximately 2 years |
| Part B: Serum Concentration of Cevostamab | Up to approximately 2 years |
| Part B: Objective Response Rate | Up to approximately 2 years |
| Part B: Rate of Complete Response (CR)/ stringent Complete Response (sCR) | Up to approximately 2 years |
| Part B: Rate of Very Good Partial Response (VGPR) or Better | Up to approximately 2 years |
| Part B: Duration of Response | Up to approximately 2 years |
| Part B: Time to First Response | Up to approximately 2 years |
| Part B: Time to Best Response | Up to approximately 2 years |
| Part B: Percentage of Participants with Anti-Drug Antibodies (ADAs) to RO7875913 at Baseline and with ADAs to RO7875913 During the Treatment Period | Up to approximately 2 years |
| Part B: Percentage of Participants with Anti-Drug Antibodies (ADAs) to Cevostamab at Baseline and with ADAs to RO7875913 During the Treatment Period | Up to approximately 2 years |
| Part B: RP2D of the RO7875913 and Cevostamab Combination Regimen | Up to approximately 2 years |
Countries
New Zealand
Contacts
STUDY_DIRECTORClinical Trials
Genentech, Inc.
Outcome results
None listed