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A Clinical Study to Evaluate the Effects of RO7875913 in Healthy Participants and of RO7875913 With Cevostamab in Participants With Relapsed/Refractory Multiple Myeloma

25. september 2026 opdateret af: Genentech, Inc.

En fase I-dosisstigningsundersøgelse til vurdering af sikkerhed, farmakokinetik og farmakodynamik for RO7875913 hos raske 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).

Studieoversigt

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

240

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Canterbury
      • Christchurch, Canterbury, New Zealand, 8011
        • New Zealand Clinical Research - Christchurch

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Sekventiel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.

Eksperimentel: 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

Hvad måler undersøgelsen?

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Efterforskere

  • Studieleder: Clinical Trials, Genentech, Inc.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

11. marts 2026

Primær færdiggørelse (Anslået)

17. juni 2030

Studieafslutning (Anslået)

17. juni 2030

Datoer for studieregistrering

Først indsendt

6. januar 2026

Først indsendt, der opfyldte QC-kriterier

6. januar 2026

Først opslået (Faktiske)

15. januar 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. september 2026

Sidst verificeret

1. september 2026

Mere information

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