Linvoseltamab
DrugAdministered per protocol
Other names: REGN5458
NCT Number: NCT06669247
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)
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 1 / Phase 2
Royal Prince Alfred Hospital, Sydney, New South Wales, Australia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol-defined Inclusion/ Exclusion Criteria apply
Administered per protocol
Other names: REGN5458
Administered per protocol
Time frame: Up to 21 days
Phase 1
Time frame: Up to 5 years
Phase 1
Time frame: Up to 5 years
Phase 1
Time frame: Within 12 weeks of starting cycle 1
Phase 2
Time frame: Within 12 weeks of starting cycle 1
Phase 2
Time frame: Within 12 weeks of starting cycle 1
Phase 2
Time frame: Within 12 weeks of starting cycle 1
Phase 2
Time frame: Up to 5 years
Phase 1 and Phase 2
Time frame: Up to 5 years
Phase 1 and Phase 2
Time frame: Up to 5 years
Phase 1 and Phase 2
Time frame: Up to 5 years
Phase 1 and Phase 2
Time frame: Up to 5 years
Phase 1 and Phase 2
Time frame: Up to 5 years
Phase 1 and Phase 2
Time frame: Up to 5 years
Phase 1 and Phase 2
Time frame: Up to 5 years
Phase 1 and Phase 2
Time frame: Up to 5 years
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.
Time frame: Up to 5 years
Phase 1 and Phase 2
Time frame: Up to 5 years
Phase 1 and Phase 2
Time frame: Up to 5 years
Phase 1 and Phase 2
Time frame: Up to 5 years
Phase 1 and Phase 2
Time frame: Up to 5 years
Phase 1 and Phase 2
Time frame: Up to 5 years
Phase 1 and Phase 2
Time frame: Up to 5 years
Phase 1 and Phase 2
Time frame: Up to 5 years
Phase 1 and Phase 2
Time frame: Up to 5 years
Phase 1 and Phase 2
Time frame: Up to 5 years
Phase 1 and Phase 2
Time frame: Up to 5 years
Phase 1 and Phase 2
Time frame: Up to 5 years
Phase 1 and Phase 2
Time frame: Up to 5 years
Phase 1 and Phase 2
Time frame: Up to 5 years
Phase 1 and Phase 2
Time frame: Up to 5 years
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.
Time frame: Up to 5 years
Phase 1 and Phase 2
Time frame: UP to 5 years
Phase 1 and Phase 2
Time frame: Up to 5 years
Phase 1 and Phase 2
Time frame: Up to 5 years
Phase 1 and Phase 2
Time frame: Up to 5 years
Phase 1 and Phase 2
Time frame: Up to 5 years
Phase 1 and Phase 2
Time frame: Up to 5 years
Phase 1 and Phase 2
Time frame: Up to 5 years
Phase 1 and Phase 2
Time frame: Up to 5 years
Phase 1 and Phase 2
Time frame: Up to 5 years
Phase 1 and Phase 2
Time frame: Up to 5 years
Phase 1 and Phase 2
Time frame: Up to 5 years
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).
Time frame: Up to 5 years
Phase 1 and Phase 2
Time frame: Up to 5 days
Phase 1 and Phase 2
Time frame: Up to 5 years
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).
Time frame: Up to 5 years
Phase 1
Time frame: Up to 5 years
Phase 1
Time frame: Up to 5 years
Phase 1
Time frame: Up to 5 years
Phase 1
Time frame: Up to 5 years
Phase 1
Time frame: Up to 5 years
Phase 1
Contact information is provided by the study sponsor or research team.
Regeneron Pharmaceuticals
Industry
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
Acronym: COSTIMM
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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