Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2024-513126-39-00 | EU Trial (CTIS) Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| REGN7945+Linvoseltamab | Experimental | Phase 1 Phase 2 |
|
| Linvoseltamab | Experimental | Phase 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Linvoseltamab | Drug | Administered per protocol |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of TEAEs | Phase 1 and Phase 2 | Up to 5 years |
| Severity of TEAEs | Phase 1 and Phase 2 | Up to 5 years |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol-defined Inclusion/ Exclusion Criteria apply
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Administrator | Contact | 844-734-6643 | clinicaltrials@regeneron.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Prince Alfred Hospital | Recruiting | Sydney | New South Wales | 2050 | Australia | |
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
When Regeneron has:
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
Not provided
Phase 1: non-randomized dose escalation Phase 2: randomized dose expansion
Not provided
Not provided
Not provided
Not provided
| REGN7945+Linvoseltamab | Drug | Administered per protocol |
|
| Within 12 weeks of starting cycle 1 |
| Concentrations of REGN7945 in the serum | Phase 1 and Phase 2 | Up to 5 years |
| Concentrations of linvoseltamab in the serum | Phase 1 and Phase 2 | Up to 5 years |
| Incidence of anti-drug antibodies (ADA) to REGN7945 | Phase 1 and Phase 2 | Up to 5 years |
| Titer of ADA to REGN7945 | Phase 1 and Phase 2 | Up to 5 years |
| Incidence of ADA to linvoseltamab | Phase 1 and Phase 2 | Up to 5 years |
| Titer of ADA to linvoseltamab | Phase 1 and Phase 2 | Up to 5 years |
| 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) | Phase 1 and Phase 2 The EORTC QLQ-C30 is a 30-item validated questionnaire developed to measure patient-reported quality of life using one global health status/quality of life (GHS/QoL) scale, 5 functioning scales (physical, role, emotional, cognitive, and social) ranging from from 1 = "very poor" to 5 = "excellent" and 9 symptom scales/items (fatigue, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties) among patients with cancer, ranging from 1 = "not at all" to 9 = "very much" higher scores indicate higher symptom burden. | Up to 5 years |
| Change in EORTC QLQ-C30 Physical Functioning (PF) | Phase 1 and Phase 2 | Up to 5 years |
| Change in EORTC QLQ-C30 Role Functioning (RF) | Phase 1 and Phase 2 | Up to 5 years |
| Change in EORTC QLQ-C30 pain | Phase 1 and Phase 2 | Up to 5 years |
| Change in EORTC QLQ-C30 fatigue | Phase 1 and Phase 2 | Up to 5 years |
| Time to definitive deterioration in EORTC QLQ-C30 GHS/QoL | Phase 1 and Phase 2 | Up to 5 years |
| Time to definitive deterioration in EORTC QLQ-C30 PF | Phase 1 and Phase 2 | Up to 5 years |
| Time to definitive deterioration in EORTC QLQ-C30 RF | Phase 1 and Phase 2 | Up to 5 years |
| Time to definitive deterioration in EORTC QLQ-C30 pain | Phase 1 and Phase 2 | Up to 5 years |
| Time to definitive deterioration in EORTC QLQ-C30 fatigue | Phase 1 and Phase 2 | Up to 5 years |
| Time to first improvement in EORTC QLQ-C30 GHS/QoL | Phase 1 and Phase 2 | Up to 5 years |
| Time to first improvement in EORTC QLQ-C30 PF | Phase 1 and Phase 2 | Up to 5 years |
| Time to first improvement in EORTC QLQ-C30 RF | Phase 1 and Phase 2 | Up to 5 years |
| Time to first improvement in EORTC QLQ-C30 pain | Phase 1 and Phase 2 | Up to 5 years |
| Time to first improvement in EORTC QLQ-C30 fatigue | Phase 1 and Phase 2 | Up to 5 years |
| Change in EORTC QLQ-Multiple Myeloma Module (MY20) Disease Symptoms (DS) | Phase 1 and Phase 2 The EORTC QLQ-MY20 is a self -administered instrument to assess QoL in persons with Multiple Myeloma (MM). This 20-item questionnaire measures the following domains: symptom scales, including disease symptoms (6 items) and symptoms related to side effects of treatment (10 items); function scale and future perspective (3 items); and body image (1 item). A high score represents a high level of symptoms or problems. | Up to 5 years |
| Change in EORTC QLQ-MY20 Treatment Side Effects (TSE) | Phase 1 and Phase 2 | Up to 5 years |
| Change in EORTC QLQ-MY20 Body Image (BI) | Phase 1 and Phase 2 | UP to 5 years |
| Change in EORTC QLQ-MY20 Future Perspective (FP) | Phase 1 and Phase 2 | Up to 5 years |
| Time to definitive deterioration in EORTC QLQ-MY20 DS | Phase 1 and Phase 2 | Up to 5 years |
| Time to definitive deterioration in EORTC QLQ-MY20 TSE | Phase 1 and Phase 2 | Up to 5 years |
| Time to definitive deterioration in EORTC QLQ-MY20 BI | Phase 1 and Phase 2 | Up to 5 years |
| Time to definitive deterioration in EORTC QLQ-MY20 FP | Phase 1 and Phase 2 | Up to 5 years |
| Time to first improvement in EORTC QLQ-MY20 DS | Phase 1 and Phase 2 | Up to 5 years |
| Time to first improvement in EORTC QLQ-MY20 TSE | Phase 1 and Phase 2 | Up to 5 years |
| Time to first improvement in EORTC QLQ-MY20 BI | Phase 1 and Phase 2 | Up to 5 years |
| Time to first improvement in EORTC QLQ-MY20 FP | Phase 1 and Phase 2 | Up to 5 years |
| Change in EuroQoL-5 Dimensions, 5-level Questionnaire (EQ-5D-5L) Visual Analogue Score (VAS) (EQ-5D-5L VAS) | Phase 1 and Phase 2 The EQ-5D-5L is a generic questionnaire that measures Health-Related Quality of Life (HRQoL) across 5 dimensions of health (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) across 5 levels (no problems, slight problems, some problems, severe problems and extreme problems) and a visual analogue scale (VAS). | Up to 5 years |
| Time to definitive deterioration in EQ-5D-5L VAS | Phase 1 and Phase 2 | Up to 5 years |
| Time to first improvement in EQ-5D-5L VAS | Phase 1 and Phase 2 | Up to 5 days |
| Patient-reported overall impact of treatment toxicity measured by Functional Assessment of Cancer Therapy (FACIT)-Item GP5 | Phase 1 and Phase 2 FACIT-Item GP5 will be used to assess the patient-reported impact of treatment toxicity that uses a single item "I am bothered by side effects of treatment" on a 5-point scale (0 = not at all, 1 = a little bit, 2 = somewhat, 3 = quite a bit, 4 = very much). | Up to 5 years |
| Objective Response Rate (ORR) as measured by IMWG criteria as determined by the investigator | Phase 1 | Up to 5 years |
| Complete response (CR) rate as measured by IMWG criteria as determined by the investigator | Phase 1 | Up to 5 years |
| Duration of response (DOR) by IMWG criteria as determined by the investigator | Phase 1 | Up to 5 years |
| Progression Free Survival (PFS) as measured by IMWG criteria as determined by the investigator | Phase 1 | Up to 5 years |
| Achievement of Minimal Residual Disease (MRD) negative status (at 10^5) in participants in CR or better | Phase 1 | Up to 5 years |
| Overall survival (OS) | Phase 1 | Up to 5 years |
| Illawarra Cancer Care Centre |
| Recruiting |
| Wollongong |
| New South Wales |
| 2500 |
| Australia |
| Pindara Private Hospital | Recruiting | Benowa | Queensland | 4217 | Australia |
| Royal Adelaide Hospital | Recruiting | Adelaide | South Australia | 5000 | Australia |
| Alfred Hospital | Recruiting | Melbourne | Victoria | 3004 | Australia |
| St Vincents Hospital Melbourne | Recruiting | Melbourne | Victoria | 3065 | Australia |
| University College London Hospitals | Recruiting | London | NW1 2PG | United Kingdom |
| The Christie NHS Foundation Trust | Recruiting | Manchester | M20 4BQ | United Kingdom |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided