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- Klinische proef NCT07342114
A Clinical Study to Evaluate the Effects of RO7875913 in Healthy Participants and of RO7875913 With Cevostamab in Participants With Relapsed/Refractory Multiple Myeloma
Een fase I dosis-escalatiestudie om de veiligheid, farmacokinetiek en farmacodynamiek van RO7875913 bij gezonde vrijwilligers te evalueren
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).
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Fase 1
Contacten en locaties
Studie Locaties
-
-
Canterbury
-
Christchurch, Canterbury, Nieuw-Zeeland, 8011
- New Zealand Clinical Research - Christchurch
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Sequentiële toewijzing
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Part A: RO7875913
Participants will receive RO7875913. |
Participants will receive RO7875913 as per the schedule described in the protocol. |
|
Placebo-vergelijker: Part A: Placebo
Participants will receive placebo. |
Participants will receive placebo as per the schedule described in the protocol. |
|
Experimenteel: Part B: RO7875913 with cevostamab
Participants will recieve RO7875913 with cevostamab. |
Participants will receive RO7875913 as per the schedule described in the protocol. Participants will receive cevostamab as per the schedule described in the protocol |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Part A: Percentage of Participants with Adverse Events (AEs)
Tijdsspanne: Up to approximately 3 months
|
Up to approximately 3 months
|
|
Part B: Percentage of Participants with Adverse Events (AEs)
Tijdsspanne: Up to approximately 2 years
|
Up to approximately 2 years
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Part A: Serum concentration of RO7875913
Tijdsspanne: Up to Day 76
|
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
Tijdsspanne: Baseline, Up to Day 76
|
Baseline, Up to Day 76
|
|
Part A: Recommended Phase II Dose (RP2D) of RO7875913
Tijdsspanne: Up to approximately 3 months
|
Up to approximately 3 months
|
|
Part A: Observed Value of Pharmacodynamic Markers
Tijdsspanne: Baseline, up to approximately 3 months
|
Baseline, up to approximately 3 months
|
|
Part B: Serum Concentration of RO7875913
Tijdsspanne: Up to approximately 2 years
|
Up to approximately 2 years
|
|
Part B: Serum Concentration of Cevostamab
Tijdsspanne: Up to approximately 2 years
|
Up to approximately 2 years
|
|
Part B: Objective Response Rate
Tijdsspanne: Up to approximately 2 years
|
Up to approximately 2 years
|
|
Part B: Rate of Complete Response (CR)/ stringent Complete Response (sCR)
Tijdsspanne: Up to approximately 2 years
|
Up to approximately 2 years
|
|
Part B: Rate of Very Good Partial Response (VGPR) or Better
Tijdsspanne: Up to approximately 2 years
|
Up to approximately 2 years
|
|
Part B: Duration of Response
Tijdsspanne: Up to approximately 2 years
|
Up to approximately 2 years
|
|
Part B: Time to First Response
Tijdsspanne: Up to approximately 2 years
|
Up to approximately 2 years
|
|
Part B: Time to Best Response
Tijdsspanne: Up to approximately 2 years
|
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
Tijdsspanne: Up to approximately 2 years
|
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
Tijdsspanne: Up to approximately 2 years
|
Up to approximately 2 years
|
|
Part B: RP2D of the RO7875913 and Cevostamab Combination Regimen
Tijdsspanne: Up to approximately 2 years
|
Up to approximately 2 years
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie directeur: Clinical Trials, Genentech, Inc.
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Vaatziekten
- Hart-en vaatziekten
- Neoplasmata
- Ziekten van het immuunsysteem
- Neoplasmata per histologisch type
- Hematologische ziekten
- Lymfoproliferatieve aandoeningen
- Immunoproliferatieve aandoeningen
- Neoplasmata, plasmacel
- Hemostatische aandoeningen
- Paraproteïnemieën
- Bloed eiwit stoornissen
- Hemorragische aandoeningen
- Hemische en lymfatische ziekten
- Multipel myeloom
Andere studie-ID-nummers
- GO46451
- 2026-526130-15-00 (Ctis)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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