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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06669247




Registration number
NCT06669247
Ethics application status
Date submitted
30/10/2024
Date registered
1/11/2024

Titles & IDs
Public title
A Study to Assess the Safety and Anti-Tumor Activity of REGN7945 in Combination With Linvoseltamab in Adult Participants With Relapsed/Refractory Multiple Myeloma
Scientific title
A First-in-Human (FIH) Phase 1/2 Study to Assess Safety, Tolerability, and Preliminary Anti-Tumor Activity of REGN7945, an Anti-CD38 x Anti-CD28 Costimulatory Bispecific Monoclonal Antibody, in Combination With Linvoseltamab, an Anti-BCMA x Anti-CD3 Bispecific Monoclonal Antibody, in Participants With Relapsed/Refractory Multiple Myeloma
Secondary ID [1] 0 0
2024-513126-39-00
Secondary ID [2] 0 0
R7945-ONC-22110
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsed/Refractory Multiple Myeloma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Linvoseltamab
Treatment: Drugs - REGN7945+Linvoseltamab

Experimental: REGN7945+Linvoseltamab - Phase 1 Phase 2

Experimental: Linvoseltamab - Phase 2


Treatment: Drugs: Linvoseltamab
Administered per protocol

Treatment: Drugs: REGN7945+Linvoseltamab
Administered per protocol
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of dose limiting toxicities (DLTs) from the first dose of REGN7945 in combination with linvoseltamab
Timepoint [1] 0 0
Up to 21 days
Primary outcome [2] 0 0
Incidence of treatment emergent adverse events (TEAEs) during the treatment period with REGN7945 in combination with linvoseltamab
Timepoint [2] 0 0
Up to 5 years
Primary outcome [3] 0 0
Severity of TEAEs during the treatment period with REGN7945 in combination with linvoseltamab
Timepoint [3] 0 0
Up to 5 years
Primary outcome [4] 0 0
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
Timepoint [4] 0 0
Within 12 weeks of starting cycle 1
Primary outcome [5] 0 0
VGPR or better as determined by the investigator using the IMWG response criteria in patients receiving linvoseltamab monotherapy
Timepoint [5] 0 0
Within 12 weeks of starting cycle 1
Primary outcome [6] 0 0
Partial Response (PR) or better as determined by the investigator using the IMWG response criteria in patients receiving combination therapy
Timepoint [6] 0 0
Within 12 weeks of starting cycle 1
Primary outcome [7] 0 0
PR or better as determined by the investigator using the IMWG response criteria in patients receiving linvoseltamab monotherapy
Timepoint [7] 0 0
Within 12 weeks of starting cycle 1
Secondary outcome [1] 0 0
Incidence of TEAEs
Timepoint [1] 0 0
Up to 5 years
Secondary outcome [2] 0 0
Severity of TEAEs
Timepoint [2] 0 0
Up to 5 years
Secondary outcome [3] 0 0
Concentrations of REGN7945 in the serum
Timepoint [3] 0 0
Up to 5 years
Secondary outcome [4] 0 0
Concentrations of linvoseltamab in the serum
Timepoint [4] 0 0
Up to 5 years
Secondary outcome [5] 0 0
Incidence of anti-drug antibodies (ADA) to REGN7945
Timepoint [5] 0 0
Up to 5 years
Secondary outcome [6] 0 0
Titer of ADA to REGN7945
Timepoint [6] 0 0
Up to 5 years
Secondary outcome [7] 0 0
Incidence of ADA to linvoseltamab
Timepoint [7] 0 0
Up to 5 years
Secondary outcome [8] 0 0
Titer of ADA to linvoseltamab
Timepoint [8] 0 0
Up to 5 years
Secondary outcome [9] 0 0
Change in European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30) Global Health Status / Quality of Life (GHS/QoL)
Timepoint [9] 0 0
Up to 5 years
Secondary outcome [10] 0 0
Change in EORTC QLQ-C30 Physical Functioning (PF)
Timepoint [10] 0 0
Up to 5 years
Secondary outcome [11] 0 0
Change in EORTC QLQ-C30 Role Functioning (RF)
Timepoint [11] 0 0
Up to 5 years
Secondary outcome [12] 0 0
Change in EORTC QLQ-C30 pain
Timepoint [12] 0 0
Up to 5 years
Secondary outcome [13] 0 0
Change in EORTC QLQ-C30 fatigue
Timepoint [13] 0 0
Up to 5 years
Secondary outcome [14] 0 0
Time to definitive deterioration in EORTC QLQ-C30 GHS/QoL
Timepoint [14] 0 0
Up to 5 years
Secondary outcome [15] 0 0
Time to definitive deterioration in EORTC QLQ-C30 PF
Timepoint [15] 0 0
Up to 5 years
Secondary outcome [16] 0 0
Time to definitive deterioration in EORTC QLQ-C30 RF
Timepoint [16] 0 0
Up to 5 years
Secondary outcome [17] 0 0
Time to definitive deterioration in EORTC QLQ-C30 pain
Timepoint [17] 0 0
Up to 5 years
Secondary outcome [18] 0 0
Time to definitive deterioration in EORTC QLQ-C30 fatigue
Timepoint [18] 0 0
Up to 5 years
Secondary outcome [19] 0 0
Time to first improvement in EORTC QLQ-C30 GHS/QoL
Timepoint [19] 0 0
Up to 5 years
Secondary outcome [20] 0 0
Time to first improvement in EORTC QLQ-C30 PF
Timepoint [20] 0 0
Up to 5 years
Secondary outcome [21] 0 0
Time to first improvement in EORTC QLQ-C30 RF
Timepoint [21] 0 0
Up to 5 years
Secondary outcome [22] 0 0
Time to first improvement in EORTC QLQ-C30 pain
Timepoint [22] 0 0
Up to 5 years
Secondary outcome [23] 0 0
Time to first improvement in EORTC QLQ-C30 fatigue
Timepoint [23] 0 0
Up to 5 years
Secondary outcome [24] 0 0
Change in EORTC QLQ-Multiple Myeloma Module (MY20) Disease Symptoms (DS)
Timepoint [24] 0 0
Up to 5 years
Secondary outcome [25] 0 0
Change in EORTC QLQ-MY20 Treatment Side Effects (TSE)
Timepoint [25] 0 0
Up to 5 years
Secondary outcome [26] 0 0
Change in EORTC QLQ-MY20 Body Image (BI)
Timepoint [26] 0 0
UP to 5 years
Secondary outcome [27] 0 0
Change in EORTC QLQ-MY20 Future Perspective (FP)
Timepoint [27] 0 0
Up to 5 years
Secondary outcome [28] 0 0
Time to definitive deterioration in EORTC QLQ-MY20 DS
Timepoint [28] 0 0
Up to 5 years
Secondary outcome [29] 0 0
Time to definitive deterioration in EORTC QLQ-MY20 TSE
Timepoint [29] 0 0
Up to 5 years
Secondary outcome [30] 0 0
Time to definitive deterioration in EORTC QLQ-MY20 BI
Timepoint [30] 0 0
Up to 5 years
Secondary outcome [31] 0 0
Time to definitive deterioration in EORTC QLQ-MY20 FP
Timepoint [31] 0 0
Up to 5 years
Secondary outcome [32] 0 0
Time to first improvement in EORTC QLQ-MY20 DS
Timepoint [32] 0 0
Up to 5 years
Secondary outcome [33] 0 0
Time to first improvement in EORTC QLQ-MY20 TSE
Timepoint [33] 0 0
Up to 5 years
Secondary outcome [34] 0 0
Time to first improvement in EORTC QLQ-MY20 BI
Timepoint [34] 0 0
Up to 5 years
Secondary outcome [35] 0 0
Time to first improvement in EORTC QLQ-MY20 FP
Timepoint [35] 0 0
Up to 5 years
Secondary outcome [36] 0 0
Change in EuroQoL-5 Dimensions, 5-level Questionnaire (EQ-5D-5L) Visual Analogue Score (VAS) (EQ-5D-5L VAS)
Timepoint [36] 0 0
Up to 5 years
Secondary outcome [37] 0 0
Time to definitive deterioration in EQ-5D-5L VAS
Timepoint [37] 0 0
Up to 5 years
Secondary outcome [38] 0 0
Time to first improvement in EQ-5D-5L VAS
Timepoint [38] 0 0
Up to 5 days
Secondary outcome [39] 0 0
Patient-reported overall impact of treatment toxicity measured by Functional Assessment of Cancer Therapy (FACIT)-Item GP5
Timepoint [39] 0 0
Up to 5 years
Secondary outcome [40] 0 0
Objective Response Rate (ORR) as measured by IMWG criteria as determined by the investigator
Timepoint [40] 0 0
Up to 5 years
Secondary outcome [41] 0 0
Complete response (CR) rate as measured by IMWG criteria as determined by the investigator
Timepoint [41] 0 0
Up to 5 years
Secondary outcome [42] 0 0
Duration of response (DOR) by IMWG criteria as determined by the investigator
Timepoint [42] 0 0
Up to 5 years
Secondary outcome [43] 0 0
Progression Free Survival (PFS) as measured by IMWG criteria as determined by the investigator
Timepoint [43] 0 0
Up to 5 years
Secondary outcome [44] 0 0
Achievement of Minimal Residual Disease (MRD) negative status (at 10^5) in participants in CR or better
Timepoint [44] 0 0
Up to 5 years
Secondary outcome [45] 0 0
Overall survival (OS)
Timepoint [45] 0 0
Up to 5 years

Eligibility
Key inclusion criteria
Key

1. Eastern Cooperative Oncology Group (ECOG) performance status =1 as described in the protocol
2. 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
3. Participants must have the measurable disease for response assessment as described in the protocol
4. Adequate hematologic, hepatic, and renal function as described in the protocol

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. 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)
2. Treatment with any systemic anti-cancer therapy within 5 half-lives or within 28 days before first administration of study drug, whichever is shorter
3. History of allogeneic stem cell transplantation within 6 months, or autologous stem cell transplantation within 12 weeks of the start of study treatment
4. 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
5. 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
6. Live or live attenuated vaccination within 28 days before first study drug administration with a vector that has replicative potential
7. Has received a COVID-19 vaccination within 1 week of planned start of study medication as described in the protocol
8. 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
9. Significant cardiovascular disease as described in the protocol
10. Uncontrolled infection with HIV, Hep B or Hep C infection, or other uncontrolled infection, such as CMV, as described in the protocol
11. Known hypersensitivity to both allopurinol and rasburicase

Note: Other protocol-defined Inclusion/ Exclusion Criteria apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/12/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/09/2035
Actual
Sample size
Target
186
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Regeneron Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trial Management
Address 0 0
Regeneron Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Clinical Trials Administrator
Address 0 0
Country 0 0
Phone 0 0
844-734-6643
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR), Analytic code
When will data be available (start and end dates)?
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
Available to whom?
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
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06669247