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).
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
Interventions
Drug | Synonyms | Arms |
---|
RO7425781 | | Part 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
Name | Type | Description | Interventions |
---|
Part I: Dose Escalation | Experimental | Participants will receive RO7425781 as intravenous (IV) infusion and/or subcutaneous (SC) injection in a step-up dosing fashion. | |
Part II: Dose Expansion | Experimental | Dose 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. | |
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 2 weeks before first RO7425781 administration.
- Prior treatment with systemic immunotherapeutic agents within 2 weeks before first
RO7425781 administration.
- 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 2 weeks except for alkylating
agents (e.g., melphalan) within 28 days, prior to first RO7425781 administration.
Limited field palliative radiotherapy for bone pain or for soft tissue lesions is
allowed.
- Autologous or allogeneic stem cell transplantation (SCT) within 100 days prior to
first RO7425781 administration 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: | Recruiting |
Lead Sponsor: | Hoffmann-La Roche |
Last Updated
August 9, 2021