- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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
Eine Phase-I-Dosis-Eskalationsstudie zur Bewertung der Sicherheit, Pharmakokinetik und Pharmakodynamik von RO7875913 bei gesunden Probanden
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).
Studienübersicht
Status
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Phase
- Phase 1
Kontakte und Standorte
Studienorte
-
-
Canterbury
-
Christchurch, Canterbury, Neuseeland, 8011
- New Zealand Clinical Research - Christchurch
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Sequenzielle Zuweisung
- Maskierung: Vervierfachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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. |
|
Experimental: 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 |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Part A: Percentage of Participants with Adverse Events (AEs)
Zeitfenster: Up to approximately 3 months
|
Up to approximately 3 months
|
|
Part B: Percentage of Participants with Adverse Events (AEs)
Zeitfenster: Up to approximately 2 years
|
Up to approximately 2 years
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Part A: Serum concentration of RO7875913
Zeitfenster: 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
Zeitfenster: Baseline, Up to Day 76
|
Baseline, Up to Day 76
|
|
Part A: Recommended Phase II Dose (RP2D) of RO7875913
Zeitfenster: Up to approximately 3 months
|
Up to approximately 3 months
|
|
Part A: Observed Value of Pharmacodynamic Markers
Zeitfenster: Baseline, up to approximately 3 months
|
Baseline, up to approximately 3 months
|
|
Part B: Serum Concentration of RO7875913
Zeitfenster: Up to approximately 2 years
|
Up to approximately 2 years
|
|
Part B: Serum Concentration of Cevostamab
Zeitfenster: Up to approximately 2 years
|
Up to approximately 2 years
|
|
Part B: Objective Response Rate
Zeitfenster: Up to approximately 2 years
|
Up to approximately 2 years
|
|
Part B: Rate of Complete Response (CR)/ stringent Complete Response (sCR)
Zeitfenster: Up to approximately 2 years
|
Up to approximately 2 years
|
|
Part B: Rate of Very Good Partial Response (VGPR) or Better
Zeitfenster: Up to approximately 2 years
|
Up to approximately 2 years
|
|
Part B: Duration of Response
Zeitfenster: Up to approximately 2 years
|
Up to approximately 2 years
|
|
Part B: Time to First Response
Zeitfenster: Up to approximately 2 years
|
Up to approximately 2 years
|
|
Part B: Time to Best Response
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Up to approximately 2 years
|
Up to approximately 2 years
|
|
Part B: RP2D of the RO7875913 and Cevostamab Combination Regimen
Zeitfenster: Up to approximately 2 years
|
Up to approximately 2 years
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienleiter: Clinical Trials, Genentech, Inc.
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Gefäßerkrankungen
- Herz-Kreislauf-Erkrankungen
- Neubildungen
- Erkrankungen des Immunsystems
- Neubildungen nach histologischem Typ
- Hämatologische Erkrankungen
- Lymphoproliferative Erkrankungen
- Immunproliferative Erkrankungen
- Neubildungen, Plasmazelle
- Hämostasestörungen
- Paraproteinämien
- Bluteiweißstörungen
- Hämorrhagische Störungen
- Hämische und lymphatische Krankheiten
- Multiples Myelom
Andere Studien-ID-Nummern
- GO46451
- 2026-526130-15-00 (Ctis)
Plan für individuelle Teilnehmerdaten (IPD)
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Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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