- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
En fase I doseøkningsstudie for å evaluere sikkerheten, farmakokinetikken og farmakodynamikken til RO7875913 hos friske frivillige
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).
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
-
-
Canterbury
-
Christchurch, Canterbury, New Zealand, 8011
- New Zealand Clinical Research - Christchurch
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Sekvensiell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Part A: RO7875913
Participants will receive RO7875913. |
Participants will receive RO7875913 as per the schedule described in the protocol. |
|
Placebo komparator: Part A: Placebo
Participants will receive placebo. |
Participants will receive placebo as per the schedule described in the protocol. |
|
Eksperimentell: 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 |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Part A: Percentage of Participants with Adverse Events (AEs)
Tidsramme: Up to approximately 3 months
|
Up to approximately 3 months
|
|
Part B: Percentage of Participants with Adverse Events (AEs)
Tidsramme: Up to approximately 2 years
|
Up to approximately 2 years
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Part A: Serum concentration of RO7875913
Tidsramme: 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
Tidsramme: Baseline, Up to Day 76
|
Baseline, Up to Day 76
|
|
Part A: Recommended Phase II Dose (RP2D) of RO7875913
Tidsramme: Up to approximately 3 months
|
Up to approximately 3 months
|
|
Part A: Observed Value of Pharmacodynamic Markers
Tidsramme: Baseline, up to approximately 3 months
|
Baseline, up to approximately 3 months
|
|
Part B: Serum Concentration of RO7875913
Tidsramme: Up to approximately 2 years
|
Up to approximately 2 years
|
|
Part B: Serum Concentration of Cevostamab
Tidsramme: Up to approximately 2 years
|
Up to approximately 2 years
|
|
Part B: Objective Response Rate
Tidsramme: Up to approximately 2 years
|
Up to approximately 2 years
|
|
Part B: Rate of Complete Response (CR)/ stringent Complete Response (sCR)
Tidsramme: Up to approximately 2 years
|
Up to approximately 2 years
|
|
Part B: Rate of Very Good Partial Response (VGPR) or Better
Tidsramme: Up to approximately 2 years
|
Up to approximately 2 years
|
|
Part B: Duration of Response
Tidsramme: Up to approximately 2 years
|
Up to approximately 2 years
|
|
Part B: Time to First Response
Tidsramme: Up to approximately 2 years
|
Up to approximately 2 years
|
|
Part B: Time to Best Response
Tidsramme: 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
Tidsramme: 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
Tidsramme: Up to approximately 2 years
|
Up to approximately 2 years
|
|
Part B: RP2D of the RO7875913 and Cevostamab Combination Regimen
Tidsramme: Up to approximately 2 years
|
Up to approximately 2 years
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Clinical Trials, Genentech, Inc.
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Vaskulære sykdommer
- Kardiovaskulære sykdommer
- Neoplasmer
- Sykdommer i immunsystemet
- Neoplasmer etter histologisk type
- Hematologiske sykdommer
- Lymfoproliferative lidelser
- Immunproliferative lidelser
- Neoplasmer, plasmacelle
- Hemostatiske lidelser
- Paraproteinemier
- Blodproteinforstyrrelser
- Hemoragiske lidelser
- Hemic og lymfatiske sykdommer
- Multippelt myelom
Andre studie-ID-numre
- GO46451
- 2026-526130-15-00 (Ctis)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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