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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]

2024-513126-39-00

Secondary ID [2]

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

Condition category

Condition code

Cancer

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]

Treatment: Drugs

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

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

Timepoint [1]

Up to 21 days

Primary outcome [2]

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

Timepoint [2]

Up to 5 years

Primary outcome [3]

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

Timepoint [3]

Up to 5 years

Primary outcome [4]

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]

Within 12 weeks of starting cycle 1

Primary outcome [5]

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

Timepoint [5]

Within 12 weeks of starting cycle 1

Primary outcome [6]

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

Timepoint [6]

Within 12 weeks of starting cycle 1

Primary outcome [7]

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

Timepoint [7]

Within 12 weeks of starting cycle 1

Secondary outcome [1]

Incidence of TEAEs

Timepoint [1]

Up to 5 years

Secondary outcome [2]

Severity of TEAEs

Timepoint [2]

Up to 5 years

Secondary outcome [3]

Concentrations of REGN7945 in the serum

Timepoint [3]

Up to 5 years

Secondary outcome [4]

Concentrations of linvoseltamab in the serum

Timepoint [4]

Up to 5 years

Secondary outcome [5]

Incidence of anti-drug antibodies (ADA) to REGN7945

Timepoint [5]

Up to 5 years

Secondary outcome [6]

Titer of ADA to REGN7945

Timepoint [6]

Up to 5 years

Secondary outcome [7]

Incidence of ADA to linvoseltamab

Timepoint [7]

Up to 5 years

Secondary outcome [8]

Titer of ADA to linvoseltamab

Timepoint [8]

Up to 5 years

Secondary outcome [9]

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]

Up to 5 years

Secondary outcome [10]

Change in EORTC QLQ-C30 Physical Functioning (PF)

Timepoint [10]

Up to 5 years

Secondary outcome [11]

Change in EORTC QLQ-C30 Role Functioning (RF)

Timepoint [11]

Up to 5 years

Secondary outcome [12]

Change in EORTC QLQ-C30 pain

Timepoint [12]

Up to 5 years

Secondary outcome [13]

Change in EORTC QLQ-C30 fatigue

Timepoint [13]

Up to 5 years

Secondary outcome [14]

Time to definitive deterioration in EORTC QLQ-C30 GHS/QoL

Timepoint [14]

Up to 5 years

Secondary outcome [15]

Time to definitive deterioration in EORTC QLQ-C30 PF

Timepoint [15]

Up to 5 years

Secondary outcome [16]

Time to definitive deterioration in EORTC QLQ-C30 RF

Timepoint [16]

Up to 5 years

Secondary outcome [17]

Time to definitive deterioration in EORTC QLQ-C30 pain

Timepoint [17]

Up to 5 years

Secondary outcome [18]

Time to definitive deterioration in EORTC QLQ-C30 fatigue

Timepoint [18]

Up to 5 years

Secondary outcome [19]

Time to first improvement in EORTC QLQ-C30 GHS/QoL

Timepoint [19]

Up to 5 years

Secondary outcome [20]

Time to first improvement in EORTC QLQ-C30 PF

Timepoint [20]

Up to 5 years

Secondary outcome [21]

Time to first improvement in EORTC QLQ-C30 RF

Timepoint [21]

Up to 5 years

Secondary outcome [22]

Time to first improvement in EORTC QLQ-C30 pain

Timepoint [22]

Up to 5 years

Secondary outcome [23]

Time to first improvement in EORTC QLQ-C30 fatigue

Timepoint [23]

Up to 5 years

Secondary outcome [24]

Change in EORTC QLQ-Multiple Myeloma Module (MY20) Disease Symptoms (DS)

Timepoint [24]

Up to 5 years

Secondary outcome [25]

Change in EORTC QLQ-MY20 Treatment Side Effects (TSE)

Timepoint [25]

Up to 5 years

Secondary outcome [26]

Change in EORTC QLQ-MY20 Body Image (BI)

Timepoint [26]

UP to 5 years

Secondary outcome [27]

Change in EORTC QLQ-MY20 Future Perspective (FP)

Timepoint [27]

Up to 5 years

Secondary outcome [28]

Time to definitive deterioration in EORTC QLQ-MY20 DS

Timepoint [28]

Up to 5 years

Secondary outcome [29]

Time to definitive deterioration in EORTC QLQ-MY20 TSE

Timepoint [29]

Up to 5 years

Secondary outcome [30]

Time to definitive deterioration in EORTC QLQ-MY20 BI

Timepoint [30]

Up to 5 years

Secondary outcome [31]

Time to definitive deterioration in EORTC QLQ-MY20 FP

Timepoint [31]

Up to 5 years

Secondary outcome [32]

Time to first improvement in EORTC QLQ-MY20 DS

Timepoint [32]

Up to 5 years

Secondary outcome [33]

Time to first improvement in EORTC QLQ-MY20 TSE

Timepoint [33]

Up to 5 years

Secondary outcome [34]

Time to first improvement in EORTC QLQ-MY20 BI

Timepoint [34]

Up to 5 years

Secondary outcome [35]

Time to first improvement in EORTC QLQ-MY20 FP

Timepoint [35]

Up to 5 years

Secondary outcome [36]

Change in EuroQoL-5 Dimensions, 5-level Questionnaire (EQ-5D-5L) Visual Analogue Score (VAS) (EQ-5D-5L VAS)

Timepoint [36]

Up to 5 years

Secondary outcome [37]

Time to definitive deterioration in EQ-5D-5L VAS

Timepoint [37]

Up to 5 years

Secondary outcome [38]

Time to first improvement in EQ-5D-5L VAS

Timepoint [38]

Up to 5 days

Secondary outcome [39]

Patient-reported overall impact of treatment toxicity measured by Functional Assessment of Cancer Therapy (FACIT)-Item GP5

Timepoint [39]

Up to 5 years

Secondary outcome [40]

Objective Response Rate (ORR) as measured by IMWG criteria as determined by the investigator

Timepoint [40]

Up to 5 years

Secondary outcome [41]

Complete response (CR) rate as measured by IMWG criteria as determined by the investigator

Timepoint [41]

Up to 5 years

Secondary outcome [42]

Duration of response (DOR) by IMWG criteria as determined by the investigator

Timepoint [42]

Up to 5 years

Secondary outcome [43]

Progression Free Survival (PFS) as measured by IMWG criteria as determined by the investigator

Timepoint [43]

Up to 5 years

Secondary outcome [44]

Achievement of Minimal Residual Disease (MRD) negative status (at 10^5) in participants in CR or better

Timepoint [44]

Up to 5 years

Secondary outcome [45]

Overall survival (OS)

Timepoint [45]

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?

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)

NSW,QLD,SA,VIC

Recruitment hospital [1]

Illawarra Cancer Care Centre - Wollongong

Recruitment hospital [2]

Pindara Private Hospital - Benowa

Recruitment hospital [3]

Royal Adelaide Hospital - Adelaide

Recruitment hospital [4]

St Vincent's Hospital - Melbourne - Fitzroy

Recruitment hospital [5]

Alfred Hospital - Melbourne

Recruitment postcode(s) [1]

2500 - Wollongong

Recruitment postcode(s) [2]

4217 - Benowa

Recruitment postcode(s) [3]

5000 - Adelaide

Recruitment postcode(s) [4]

3065 - Fitzroy

Recruitment postcode(s) [5]

3004 - Melbourne

Funding & Sponsors

Primary sponsor type

Commercial sector/industry

Name

Regeneron Pharmaceuticals

Address

Country

Ethics approval

Ethics application status

Summary

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)

Trial website

https://clinicaltrials.gov/study/NCT06669247

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Clinical Trial Management

Address

Regeneron Pharmaceuticals

Country

Phone

Fax

Contact person for public queries

Name

Clinical Trials Administrator

Address

Country

Phone

844-734-6643

Fax

[email protected]

Contact person for scientific queries

Data sharing statement

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

Register a trial

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