Clinical Trials /

A Study Evaluating the Safety and Pharmacokinetics of Escalating Doses of RO7425781 in Participants With Relapsed or Refractory Multiple Myeloma (r/r MM)

NCT04557150

Description:

This is a first-in-human, open-label, uncontrolled, multi-center, monotherapy, dose-escalation and dose expansion study. RO7425781 will be administered to participants with r/r MM for whom no standard-of-care treatment exists or who are intolerant to those established therapies. The study consists of two parts: dose-escalation of RO7425781 (Part 1) and a randomized dose expansion of RO7425781 (Part 2).

Related Conditions:
  • Multiple Myeloma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study Evaluating the Safety and Pharmacokinetics of Escalating Doses of RO7425781 in Participants With Relapsed or Refractory Multiple Myeloma (r/r MM)
  • Official Title: An Open-Label, Multicenter, Phase I Study Evaluating the Safety and Pharmacokinetics of Escalating Doses of RO7425781 in Participants With Relapsed or Refractory Multiple Myeloma

Clinical Trial IDs

  • ORG STUDY ID: BP42233
  • SECONDARY ID: 2020-002012-46
  • NCT ID: NCT04557150

Conditions

  • Multiple Myeloma

Interventions

DrugSynonymsArms
RO7425781Part I: Dose Escalation

Purpose

This is a first-in-human, open-label, uncontrolled, multi-center, monotherapy, dose-escalation and dose expansion study. RO7425781 will be administered to participants with r/r MM for whom no standard-of-care treatment exists or who are intolerant to those established therapies. The study consists of two parts: dose-escalation of RO7425781 (Part 1) and a randomized dose expansion of RO7425781 (Part 2).

Trial Arms

NameTypeDescriptionInterventions
Part I: Dose EscalationExperimentalParticipants will receive RO7425781 as intravenous (IV) and/or subcutaneous (SC) infusion in a step-up dosing fashion.
  • RO7425781
Part II: Dose ExpansionExperimentalDose Expansion cohorts with IV and/or SC administration will be initiated at the Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) determined from Part I: Dose Escalation.
  • RO7425781

Eligibility Criteria

        Inclusion Criteria:

          -  Previously diagnosed with Multiple Myeloma (MM) based on standard criteria.

          -  Dose Escalation Phase: Participants with r/r MM who have previously received therapy
             with an Immunomodulatory drug (IMiD) and Proteasome Inhibitor (PI) and are intolerant
             to or have no other option for standard-of-care treatment according to the
             Investigator.

          -  Dose Expansion Phase: Participants with r/r MM who have received at least three prior
             treatments and are refractory to an IMiD, a PI, and a CD38-targeted therapy.

          -  Life expectancy of at least 12 weeks.

          -  Agreement to provide protocol-specific biopsy material.

          -  AEs from prior anti-cancer therapy resolved to Grade =<1.

          -  Measurable disease.

          -  For female participants of childbearing potential: agreement to remain abstinent
             (refrain from heterosexual intercourse), use contraceptive measures and refrain from
             donating eggs.

          -  For male participants: agreement to remain abstinent (refrain from heterosexual
             intercourse), use contraceptive measures and refrain from donating sperm.

        Exclusion Criteria:

          -  Inability to comply with protocol-mandated hospitalization and activities
             restrictions.

          -  Pregnant or breastfeeding, or intending to become pregnant during the study or within
             3 months after the last dose of study drug.

          -  Prior use of any monoclonal antibody, radioimmunoconjugate, or antibody-drug conjugate
             within 4 weeks before first RO7425781 infusion.

          -  Prior treatment with systemic immunotherapeutic agents.

          -  Treatment-related, immune-mediated AEs associated with prior immunotherapeutic agents.

          -  Treatment with radiotherapy, 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 RO7425781 infusion.

          -  Autologous or allogeneic stem cell transplantation (SCT) within 100 days prior to
             first RO7425781 infusion and/or signs of chronic graft versus host disease or ongoing
             immunosuppressive medication.

          -  Prior solid organ transplantation.

          -  Any medical condition or abnormality in clinical laboratory tests that, in the
             Investigator's or Medical Monitor's judgment, precludes the participant's safe
             participation in and completion of the study, or which could affect compliance with
             the protocol or interpretation of results.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Percentage of Participants with Adverse Events (AEs)
Time Frame:Up to 69 weeks
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Objective Response Rate (ORR)
Time Frame:Up to 69 weeks
Safety Issue:
Description:
Measure:Duration of Response (DOR)
Time Frame:Up to 69 weeks
Safety Issue:
Description:
Measure:Progression-Free Survival (PFS)
Time Frame:Up to 69 weeks
Safety Issue:
Description:
Measure:Overall Survival (OS)
Time Frame:Up to 69 weeks
Safety Issue:
Description:
Measure:Percentage of Participants with Anti-Drug Antibodies (ADAs) to RO7425781
Time Frame:Up to 69 weeks
Safety Issue:
Description:
Measure:Maximum concentration (Cmax) of RO7425781
Time Frame:Up to 69 weeks
Safety Issue:
Description:
Measure:Time of Maximum concentration (Tmax) of RO7425781
Time Frame:Up to 69 weeks
Safety Issue:
Description:
Measure:Minimum concentration (Cmin) of RO7425781
Time Frame:Up to 69 weeks
Safety Issue:
Description:
Measure:SC Bioavailability (F) of RO7425781
Time Frame:Up to 69 weeks
Safety Issue:
Description:
Measure:Apparent Clearance (CL/F) of RO7425781
Time Frame:Up to 69 weeks
Safety Issue:
Description:
Measure:Volume of distribution at steady state (Vss) of RO7425781 (IV only)
Time Frame:Up to 69 weeks
Safety Issue:
Description:
Measure:Area under the curve (AUC) at various time intervals of RO7425781
Time Frame:Up to 69 weeks
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Hoffmann-La Roche

Last Updated

October 12, 2020