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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04557150
Recruitment Status : Recruiting
First Posted : September 21, 2020
Last Update Posted : June 28, 2022
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE September 17, 2020
First Posted Date  ICMJE September 21, 2020
Last Update Posted Date June 28, 2022
Actual Study Start Date  ICMJE November 11, 2020
Estimated Primary Completion Date July 13, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 17, 2020)
  • Percentage of Participants with Adverse Events (AEs) [ Time Frame: Up to 69 weeks ]
  • Percentage of Participants with Dose Limiting Toxicities (DLTs) [ Time Frame: Up to 69 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 17, 2020)
  • Objective Response Rate (ORR) [ Time Frame: Up to 69 weeks ]
  • Duration of Response (DOR) [ Time Frame: Up to 69 weeks ]
  • Progression-Free Survival (PFS) [ Time Frame: Up to 69 weeks ]
  • Overall Survival (OS) [ Time Frame: Up to 69 weeks ]
  • Percentage of Participants with Anti-Drug Antibodies (ADAs) to RO7425781 [ Time Frame: Up to 69 weeks ]
  • Maximum concentration (Cmax) of RO7425781 [ Time Frame: Up to 69 weeks ]
  • Time of Maximum concentration (Tmax) of RO7425781 [ Time Frame: Up to 69 weeks ]
  • Minimum concentration (Cmin) of RO7425781 [ Time Frame: Up to 69 weeks ]
  • SC Bioavailability (F) of RO7425781 [ Time Frame: Up to 69 weeks ]
  • Apparent Clearance (CL/F) of RO7425781 [ Time Frame: Up to 69 weeks ]
  • Volume of distribution at steady state (Vss) of RO7425781 (IV only) [ Time Frame: Up to 69 weeks ]
  • Area under the curve (AUC) at various time intervals of RO7425781 [ Time Frame: Up to 69 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Myeloma
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Part I: Dose Escalation
    Participants will receive RO7425781 as intravenous (IV) infusion and/or subcutaneous (SC) injection in a step-up dosing fashion.
    Intervention: Drug: RO7425781
  • 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.
    Intervention: Drug: RO7425781
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 17, 2020)
240
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 13, 2022
Estimated Primary Completion Date July 13, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Reference Study ID Number: BP42233 https://forpatients.roche.com/ 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com
Listed Location Countries  ICMJE Australia,   Belgium,   Denmark,   France,   Italy,   Korea, Republic of,   Spain,   United Kingdom
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT04557150
Other Study ID Numbers  ICMJE BP42233
2020-002012-46 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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).
Current Responsible Party Hoffmann-La Roche
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Hoffmann-La Roche
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date June 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP