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

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ClinicalTrials.gov Identifier: NCT04557150
Recruitment Status : Recruiting
First Posted : September 21, 2020
Last Update Posted : October 4, 2021
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: RO7425781 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : November 11, 2020
Estimated Primary Completion Date : July 13, 2022
Estimated Study Completion Date : July 13, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: Part I: Dose Escalation
Participants will receive RO7425781 as intravenous (IV) infusion and/or subcutaneous (SC) injection in a step-up dosing fashion.
Drug: RO7425781
RO7425781 will be administered via IV/SC administration. The MTD/RP2D determined during Part I: Dose Escalation will be administered during Part II: Dose Expansion. RO7425781 will be administered as per the dosing schedule defined in Part I.

Experimental: Part II: Dose Expansion
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.
Drug: RO7425781
RO7425781 will be administered via IV/SC administration. The MTD/RP2D determined during Part I: Dose Escalation will be administered during Part II: Dose Expansion. RO7425781 will be administered as per the dosing schedule defined in Part I.




Primary Outcome Measures :
  1. Percentage of Participants with Adverse Events (AEs) [ Time Frame: Up to 69 weeks ]
  2. Percentage of Participants with Dose Limiting Toxicities (DLTs) [ Time Frame: Up to 69 weeks ]

Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: Up to 69 weeks ]
  2. Duration of Response (DOR) [ Time Frame: Up to 69 weeks ]
  3. Progression-Free Survival (PFS) [ Time Frame: Up to 69 weeks ]
  4. Overall Survival (OS) [ Time Frame: Up to 69 weeks ]
  5. Percentage of Participants with Anti-Drug Antibodies (ADAs) to RO7425781 [ Time Frame: Up to 69 weeks ]
  6. Maximum concentration (Cmax) of RO7425781 [ Time Frame: Up to 69 weeks ]
  7. Time of Maximum concentration (Tmax) of RO7425781 [ Time Frame: Up to 69 weeks ]
  8. Minimum concentration (Cmin) of RO7425781 [ Time Frame: Up to 69 weeks ]
  9. SC Bioavailability (F) of RO7425781 [ Time Frame: Up to 69 weeks ]
  10. Apparent Clearance (CL/F) of RO7425781 [ Time Frame: Up to 69 weeks ]
  11. Volume of distribution at steady state (Vss) of RO7425781 (IV only) [ Time Frame: Up to 69 weeks ]
  12. Area under the curve (AUC) at various time intervals of RO7425781 [ Time Frame: Up to 69 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04557150


Contacts
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Contact: Reference Study ID Number: BP42233 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

Locations
Show Show 18 study locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT04557150    
Other Study ID Numbers: BP42233
2020-002012-46 ( EudraCT Number )
First Posted: September 21, 2020    Key Record Dates
Last Update Posted: October 4, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases