A Study Evaluating The Safety And Pharmacokinetics Of Escalating Doses Of RO7297089 In Patients With Relapsed Or Refractory Multiple Myeloma

NCT ID: NCT04434469

Last Updated: 2024-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-08
• Study Completion Date: 2022-02-23

Brief Summary

This is a first-in-human Phase I, open-label, multicenter, global, dose-escalation study designed to evaluate the safety, tolerability, and pharmacokinetics of RO7297089 and make a preliminary assessment of anti-tumor activity in patients with R/R MM for whom no established therapy for MM is appropriate and available or who are intolerant to those established therapies.

Conditions

Refractory Multiple Myeloma; Relapsed Multiple Myeloma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A Flat Dose Escalation: RO7297089

Participants in Arm A will receive the target dose of RO7297089 as a flat dose at each scheduled study drug administration visit

Group Type: EXPERIMENTAL

RO7297089

Intervention Type: DRUG

RO7297089 will be given via intravenous (IV) infusion

Arm B Split Dose Escalation: RO7297089

Participants in Arm B will receive the first target dose of RO7297089 as a split dose divided over two days (Days 1 and 2). The full target dose will be administered at subsequent study drug administration visits.

Group Type: EXPERIMENTAL

RO7297089

Intervention Type: DRUG

RO7297089 will be given via intravenous (IV) infusion

Arm C Step Dose Escalation: RO7297089

No participants enrolled. Enrollment for the GO41582 study was stopped in July 2021 due to limited activity as a single agent which did not meet the Sponsor's internal criteria for further clinical development.

Group Type: EXPERIMENTAL

RO7297089

Intervention Type: DRUG

RO7297089 will be given via intravenous (IV) infusion

Phase I Expansion Stage: RO7297089

No participants enrolled. Enrollment for the GO41582 study was stopped in July 2021 due to limited activity as a single agent which did not meet the Sponsor's internal criteria for further clinical development.

Group Type: EXPERIMENTAL

RO7297089

Intervention Type: DRUG

RO7297089 will be given via intravenous (IV) infusion

Interventions

RO7297089

RO7297089 will be given via intravenous (IV) infusion

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
• Life expectancy of at least 12 weeks
• R/R MM for which no established therapy for MM is appropriate and available or be intolerant to those established therapies
• Measurable disease

Exclusion Criteria

• Prior use of any monoclonal antibody, radioimmunoconjugate, or antibody-drug conjugate for the treatment of cancer within 4 weeks before first RO7297089 infusion
• Prior treatment with systemic immunotherapeutic agents within 12 weeks or 5 half-lives of the drug, whichever is shorter, before first RO7297089 infusion
• Prior treatment with CAR-T therapy within 90 days before first study drug administration
• Treatment with any 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 RO7297089 infusion
• Autologous stem cell transplantation within 100 days prior to first RO7297089 infusion
• Allogeneic stem cell transplantation within 180 days prior to first RO7297089 infusion or requiring immunosuppression for treatment or prophylaxis of graft versus host disease
• Primary or secondary plasma cell leukemia
• Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection requiring treatment with IV anti-microbial therapy within 14 days prior to first RO7297089 infusion
• Significant cardiovascular disease
• Current CNS involvement by MM

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Concord Repatriation General Hospital

Concord, New South Wales, Australia

LIVERPOOL HOSPITAL; HAEMATOLOGY; Ingham Institute for Medical Research

Liverpool, New South Wales, Australia

Royal Adelaide Hospital; Haematology Clinical Trials

Adelaide, South Australia, Australia

St. Vincent's Hospital Melbourne

Fitzroy, South Australia, Australia

Peter Mac Callum Cancer Center

East Melbourne, Victoria, Australia

UZ Gent

Ghent, , Belgium

UZ Leuven

Leuven, , Belgium

Rigshospitalet

København Ø, , Denmark

Vejle Sygehus; Onkologisk Afdeling

Vejle, , Denmark

Oslo Universitetssykehus HF; Ullevål sykehus

Oslo, , Norway

Countries

Australia; Belgium; Denmark; Norway

References

Plesner T, Harrison SJ, Quach H, Lee C, Bryant A, Vangsted A, Estell J, Delforge M, Offner F, Twomey P, Choeurng V, Li J, Hendricks R, Ruppert SM, Sumiyoshi T, Miller K, Cho E, Schjesvold F. Phase I Study of Safety and Pharmacokinetics of RO7297089, an Anti-BCMA/CD16a Bispecific Antibody, in Patients with Relapsed, Refractory Multiple Myeloma. Clin Hematol Int. 2023 Mar;5(1):43-51. doi: 10.1007/s44228-022-00023-5. Epub 2023 Jan 19.

Reference Type: DERIVED

PMID: 36656461 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

GO41582

Identifier Type: -

Identifier Source: org_study_id