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

Genentech

Status and phase: Completed; Phase 1

Conditions: Refractory Multiple Myeloma; Relapsed Multiple Myeloma

Treatments: Drug: RO7297089

Study type: Interventional

Funder types: Industry

Identifiers

NCT04434469

GO41582

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

27 participants in 4 patient groups

Arm A Flat Dose Escalation: RO7297089

Experimental group

Description:

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

Treatment:

Drug: RO7297089

Arm B Split Dose Escalation: RO7297089

Experimental group

Description:

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.

Treatment:

Drug: RO7297089

Arm C Step Dose Escalation: RO7297089

Experimental group

Description:

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.

Treatment:

Drug: RO7297089

Phase I Expansion Stage: RO7297089

Experimental group

Description:

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.

Treatment:

Drug: RO7297089