A Trial to Study if REGN17372 in Combination with Linvoseltamab is Tolerable for Adult Participants with Relapsed/Refractory Multiple Myeloma

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Regeneron Pharmaceuticals Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Decision date (initial)

2026-04-22

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

Phase 1: Dose Escalation
• To evaluate the safety, tolerability, and to determine RP2D regimens, of REGN17372 in combination with linvoseltamab in participants with RRMM

Phase 2: Dose Expansion
• To assess the preliminary anti-tumor activity of the two RP2D regimens of REGN17372 in combination with linvoseltamab and of linvoseltamab monotherapy in participants with RRMM

Secondary objectives 8

1. Phase 1 and Phase 2: To evaluate the PK of REGN17372 when given in combination with linvoseltamab
2. Phase 1 and Phase 2: To evaluate the PK of linvoseltamab when given in combination with REGN17372
3. Phase 1 and Phase 2: To assess the immunogenicity of REGN17372 and linvoseltamab
4. Phase 1 and Phase 2: To assess the preliminary anti-tumor activity of REGN17372 in combination with linvoseltamab and of linvoseltamab monotherapy
5. Phase 1: To assess the anti-tumor activity of REGN17372 in combination with linvoseltamab
6. Phase 2: To evaluate the safety and tolerability of study treatments in participants with RRMM
7. Phase 2: To evaluate the effects of REGN17372 in combination with linvoseltamab on HRQoL and patient-reported functioning and symptoms
8. Phase 2: Patient-reported tolerability related to cutaneous and oral symptomatic toxicities

Conditions and MedDRA coding

Relapsed/Refractory Multiple Myeloma

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration

Plan to share IPD

Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Participants with RRMM who have exhausted (or are not a candidate for) all therapeutic options that are expected to provide meaningful clinical benefit and have received at least 3 lines of therapy as defined in the protocol
2. ECOG performance status score ≤1
3. Participants must have measurable disease for response assessment as described in the protocol
4. Adequate hematologic, cardiac, hepatic, and renal function, as described in the protocol

Exclusion criteria 5

1. Participants with non-secretory MM, active plasma cell leukemia, known amyloidosis, Waldenström macroglobulinemia, or known POEMS syndrome as defined in the protocol
2. Participants who have known MM brain lesions or CNS involvement
3. Participants with a history of PML, a neurocognitive condition or CNS movement disorder, or a history of seizure within 12 months prior to entering screening
4. Prior treatment with GPRC5D-directed immunotherapies (phase 1 and phase 2) and/or prior treatment with a BCMAxCD3 bispecific antibody (phase 2)
5. Note: Other protocol defined inclusion/exclusion criteria apply

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 7

1. Phase 1: Occurrence of Dose Limiting Toxicities (DLTs) from the first dose of REGN17372 in combination with linvoseltamab
2. Phase 1: Occurrence of Treatment Emergent Adverse Events (TEAEs) associated with REGN17372 in combination with linvoseltamab
3. Phase 1: Severity of TEAEs associated with REGN17372 in combination with linvoseltamab
4. Phase 2: 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 study drugs
5. Phase 2: VGPR or better as determined by the investigator using the IMWG response criteria in patients receiving Linvoseltamab monotherapy
6. Phase 2: Partial Response (PR) or better as determined by the investigator using the IMWG response criteria in patients receiving combination study drugs
7. Phase 2: PR or better as determined by the investigator using the IMWG response criteria in patients receiving Linvoseltamab monotherapy

Secondary endpoints 43

1. Phase 1 and Phase 2: Concentrations of REGN17372 in serum
2. Phase 1 and Phase 2: Concentrations of linvoseltamab in serum
3. Phase 1 and Phase 2: Occurrence of Anti-Drug Antibodies (ADA) to REGN17372
4. Phase 1 and Phase 2: Magnitude of ADA to REGN17372
5. Phase 1 and Phase 2: Incidence of ADA to linvoseltamab
6. Phase 1 and Phase 2: Magnitude of ADA to linvoseltamab
7. Phase 1 and Phase 2: Objective Response Rate (ORR) as assessed by IMWG response criteria as determined by the investigator
8. Phase 1 and Phase 2: Complete response (CR) as assessed by IMWG response criteria as determined by the investigator
9. Phase 1 and Phase 2: VGPR as assessed by IMWG response criteria, as determined by the investigator
10. Phase 1 and Phase 2: Duration of Response (DOR) as assessed by IMWG criteria as determined by the investigator
11. Phase 1 and Phase 2: Progression Free Survival (PFS) as assessed by IMWG criteria as determined by the investigator
12. Phase 1 and Phase 2: Minimal Residual Disease (MRD) negative status (at 10^-5) in participants in CR or better
13. Phase 1 and Phase 2: Overall Survival (OS)
14. Phase 1: ORR as assessed using the IMWG response criteria as determined by the investigator in patients receiving combination study drugs
15. Phase 1:VGPR assessed using IMWG criteria as determined by the investigator in patients receiving combination study drugs
16. Phase 2: Incidence of TEAEs
17. Phase 2: Severity of TEAEs
18. Phase 2: Change from baseline 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)
19. Phase 2: Change from baseline in EORTC QLQ-C30 Physical Functioning (PF)
20. Phase 2: Change from baseline in EORTC QLQ-C30 Role Functioning (RF)
21. Phase 2: Change from baseline in EORTC QLQ-C30 pain
22. Phase 2: Change from baseline in EORTC QLQ-C30 fatigue
23. Phase 2: Time to definitive deterioration in EORTC QLQ-C30 GHS/QoL
24. Phase 2: Time to definitive deterioration in EORTC QLQ-C30 PF
25. Phase 2: Time to definitive deterioration in EORTC QLQ-C30 RF
26. Phase 2: Time to definitive deterioration in EORTC QLQ-C30 pain
27. Phase 2: Time to definitive deterioration in EORTC QLQ-C30 fatigue
28. Phase 2: Time to first improvement in EORTC QLQ-C30 GHS/QoL
29. Phase 2: Time to first improvement in EORTC QLQ-C30 PF
30. Phase 2: Time to first improvement in EORTC QLQ-C30 RF
31. Phase 2: Time to first improvement in EORTC QLQ-C30 pain
32. Phase 2: Time to first improvement in EORTC QLQ-C30 fatigue
33. Phase 2: Change from baseline in EORTC QLQ-Multiple Myeloma Module (MY20) Disease Symptoms (DS)
34. Phase 2: Time to definitive deterioration in EORTC QLQ-MY20 DS
35. Phase 2: Time to first improvement in EORTC QLQ-MY20 DS
36. Phase 2: Change from baseline in EORTC QLQ-MY20 Treatment Side Effects (TSE)
37. Phase 2: Time to definitive deterioration in EORTC QLQ-MY20 TSE
38. Phase 2: Time to first improvement in EORTC QLQ-MY20 TSE
39. Phase 2: Change from baseline in EuroQoL-5 Dimensions, 5-level Questionnaire (EQ-5D-5L) Visual Analogue Score (VAS) (EQ-5D-5L VAS)
40. Phase 2: Time to definitive deterioration in EQ-5D-5L VAS
41. Phase 2: Time to first improvement in EQ-5D-5L VAS
42. Phase 2: Patient-reported overall impact of treatment toxicity measured by Functional Assessment of Cancer Therapy (FACIT) Item GP5
43. Phase 2: Patient-reported tolerability as measured by the Patient Reported Outcome-Common Terminology Criteria for Adverse Events (PRO-CTCAE)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Auxiliary 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Regeneron Pharmaceuticals Inc.

Sponsor organisation

Regeneron Pharmaceuticals Inc.

Address

777 Old Saw Mill River Road

City

Tarrytown

Postcode

10591-6717

Country

United States

Scientific contact point

Organisation

Regeneron Pharmaceuticals Inc.

Contact name

Medical Affairs

Public contact point

Organisation

Regeneron Pharmaceuticals Inc.

Contact name

Medical Affairs

Third parties 8

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 11 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications