A Study to Assess the Safety and Anti-Tumor Activity of REGN7945 in Combination With Linvoseltamab in Adult Participants With Relapsed/Refractory Multiple Myeloma

NCT06669247 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: R7945-ONC-221102024-513126-39-00
• Study Type: interventional
• Target: 186
• Locations: 2 countries
• Sites: 7

Brief Summary

This study is researching an experimental drug called REGN7945 in combination with another experimental drug called linvoseltamab, (also known as REGN5458) (each individually called a "study drug" or "study drugs" when combined). This study is the first time REGN7945 will be tested in humans. Linvoseltamab has previously been studied by itself (without other cancer drugs) in participants who had advanced multiple myeloma that returned and needed to be treated again after several other therapies had failed. The aim of the study is to see how safe, tolerable, and effective REGN7945 is when given in combination with linvoseltamab, compared with linvoseltamab alone. The study is looking at several other research questions, including:

• What side effects may happen from taking the study drug(s)
• How many people treated with REGN7945 and linvoseltamab compared to linvoseltamab alone have improvement of their multiple myeloma and by how much
• How long people benefit from receiving REGN7945 in combination with linvoseltamab compared with linvoseltamab alone
• How much study drug(s) is in the blood at different times
• Whether the body makes antibodies against the study drugs(s) (which could make the study drug(s) less effective or could lead to side effects)
• If there is any change in pain and cancer-related symptoms, how well people are able to function, and their quality of life when taking the study drug(s)

Conditions

Relapsed/Refractory Multiple Myeloma

Keywords

R/RMM

Outcome Measures

Primary Outcomes (7)

• Incidence of dose limiting toxicities (DLTs) from the first dose of REGN7945 in combination with linvoseltamab

  Phase 1

  Up to 21 days

• Incidence of treatment emergent adverse events (TEAEs) during the treatment period with REGN7945 in combination with linvoseltamab

  Phase 1

  Up to 5 years

• Severity of TEAEs during the treatment period with REGN7945 in combination with linvoseltamab

  Phase 1

  Up to 5 years

• Very Good Partial Response (VGPR) or better as determined by the investigator using the International Myeloma Working Group (IMWG) response criteria in patients receiving combination therapy

  Phase 2

  Within 12 weeks of starting cycle 1

• VGPR or better as determined by the investigator using the IMWG response criteria in patients receiving linvoseltamab monotherapy

  Phase 2

  Within 12 weeks of starting cycle 1

• Partial Response (PR) or better as determined by the investigator using the IMWG response criteria in patients receiving combination therapy

  Phase 2

  Within 12 weeks of starting cycle 1

• PR or better as determined by the investigator using the IMWG response criteria in patients receiving linvoseltamab monotherapy

  Phase 2

  Within 12 weeks of starting cycle 1

Secondary Outcomes (45)

• Incidence of TEAEs

  Up to 5 years

• Severity of TEAEs

  Up to 5 years

• Concentrations of REGN7945 in the serum

  Up to 5 years

• Concentrations of linvoseltamab in the serum

  Up to 5 years

• Incidence of anti-drug antibodies (ADA) to REGN7945

  Up to 5 years

Study Arms (2)

REGN7945+Linvoseltamab

EXPERIMENTAL

Phase 1 Phase 2

Drug: REGN7945+Linvoseltamab

Linvoseltamab

EXPERIMENTAL

Phase 2

Drug: Linvoseltamab; Drug: REGN7945+Linvoseltamab

Interventions

Linvoseltamab DRUG

Administered per protocol

Also known as: REGN5458

Linvoseltamab

REGN7945+Linvoseltamab DRUG

Administered per protocol

Linvoseltamab; REGN7945+Linvoseltamab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eastern Cooperative Oncology Group (ECOG) performance status ≤1 as described in the protocol
• Received at least 3 lines of therapy including exposure to at least 1 anti-CD38 antibody, 1 immunomodulatory imide drug (IMiD), and 1 proteasome inhibitor (PI) and have demonstrated disease progression on or after the last therapy, as defined in the protocol. Prior treatment with other BCMA directed immunotherapies, including BCMA CAR-T cells and BCMA antibody-drug conjugates (Phase 1 and 2), and with BCMA x CD3 bispecific antibodies (Phase 1 only), is allowed
• Participants must have the measurable disease for response assessment as described in the protocol
• Adequate hematologic, hepatic, and renal function as described in the protocol

You may not qualify if:

• Diagnosis of plasma cell leukemia, primary systemic light-chain amyloidosis (including myeloma associated amyloidosis), Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
• Treatment with any systemic anti-cancer therapy within 5 half-lives or within 28 days before first administration of study drug, whichever is shorter
• History of allogeneic stem cell transplantation within 6 months, or autologous stem cell transplantation within 12 weeks of the start of study treatment
• Treatment with systemic corticosteroid treatment with more than 10 mg per day of prednisone or steroid equivalent within 72 hours of start of study drug
• Participants who have known central nervous system (CNS) involvement with MM or known or suspected progressive multifocal leukoencephalopathy (PML), history of a neurocognitive condition or CNS disorder, or history of seizure within 12 months prior to study enrollment
• Live or live attenuated vaccination within 28 days before first study drug administration with a vector that has replicative potential
• Has received a COVID-19 vaccination within 1 week of planned start of study medication as described in the protocol
• Myelodysplastic syndrome or another malignancy in the past 3 years, except for nonmelanoma skin cancer, in situ carcinoma, thyroid cancer, or low-risk early stage prostate adenocarcinoma, as described in the protocol
• Significant cardiovascular disease as described in the protocol
• Uncontrolled infection with HIV, Hep B or Hep C infection, or other uncontrolled infection, such as CMV, as described in the protocol
• Known hypersensitivity to both allopurinol and rasburicase

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (7)

Illawarra Cancer Care Centre

Wollongong, New South Wales, 2500, Australia

RECRUITING

Pindara Private Hospital

Benowa, Queensland, 4217, Australia

RECRUITING

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

RECRUITING

Alfred Hospital

Melbourne, Victoria, 3004, Australia

RECRUITING

St Vincents Hospital Melbourne

Melbourne, Victoria, 3065, Australia

RECRUITING

University College London Hospitals

London, NW1 2PG, United Kingdom

RECRUITING

The Christie NHS Foundation Trust

Manchester, M20 4BQ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Clinical Trials Administrator

CONTACT

844-734-6643; clinicaltrials@regeneron.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase 1: non-randomized dose escalation Phase 2: randomized dose expansion

Study Record Dates

• First Submitted: October 30, 2024
• First Posted: November 1, 2024
• Study Start: December 11, 2024
• Primary Completion (Estimated): November 11, 2033
• Study Completion (Estimated): November 1, 2035
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: When Regeneron has: * received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development * made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) * the legal authority to share the data, and * ensured the ability to protect participant privacy
• Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

Locations

AU (5); GB (2)