Phase 1
Completed N=27
A Study Evaluating The Safety And Pharmacokinetics Of Escalating Doses Of RO7297089 In Patients With Relapsed Or Refractory Multiple Myeloma
Source: ClinicalTrials.gov NCT04434469 ↗Enrolled (actual)
27
Serious AEs
70.4%
Results posted
Jul 2024
Primary outcomePrimary: Percentage of Participants With Adverse Events (AEs), Including Dose Limiting Toxicities (DLTs) — 100; 100; 75; 100 Percentage of Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Adverse Events (AEs), Including Dose Limiting Toxicities (DLTs) |
100; 100; 75; 100; 83.3; 100 | — |
| SECONDARY Time to Maximum Concentration Observed (Tmax) of RO7297089 |
0.25; 0.17; 0.08; 0.25; 1.08; 1.08 | — |
| SECONDARY Area Under the Curve (AUC) of RO7297089 |
12.7; 78.7; 280; 1347; 1046; 1920 | — |
| SECONDARY Maximum Concentration Observed (Cmax) of RO7297089 |
7.79; 40.9; 95.9; 314; 305; 404 | — |
| SECONDARY Minimum Concentration Observed (Cmin) of RO7297089 |
0.19; 0.96; 9.19; 140; 81.3; 197 | — |
| SECONDARY Half-life (t1/2) of RO7297089 |
1.39; 1.25; 2.39; 6.73; 4.22; 6.52 | — |
| SECONDARY Objective Response Rate (ORR) |
0; 0; 0; 1; 0; 1 | — |
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
Data sourced from ClinicalTrials.gov (NCT04434469). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.