Clinical Trials Using Anti-BCMA Antibody-drug Conjugate GSK2857916
Clinical trials are research studies that involve people. The clinical trials on this list are studying Anti-BCMA Antibody-drug Conjugate GSK2857916. All trials on the list are supported by NCI.
NCI’s basic information about clinical trials explains the types and phases of trials and how they are carried out. Clinical trials look at new ways to prevent, detect, or treat disease. You may want to think about taking part in a clinical trial. Talk to your doctor for help in deciding if one is right for you.
Study Evaluating Safety, Tolerability and Clinical Activity of GSK2857916 in Combination With Pembrolizumab in Subjects With Relapsed / Refractory Multiple Myeloma (RRMM)
This is a phase I / II, single arm, open label, two-part study that will assess safety, tolerability and clinical activity of GSK2857916 given in combination with a programmed cell death-1 (PD-1) inhibitor pembrolizumab in subjects with RRMM. This study will enroll adult subjects with RRMM, who have undergone stem cell transplant or who are considered transplant ineligible. Part 1 is a dose escalation phase to evaluate the safety and tolerability of escalating doses of GSK2857916 in combination with 200 milligrams (mg) pembrolizumab to establish the recommended phase 2 dose (RP2D). The following dose levels of GSK2857916 are planned to be studied: 2.5 milligrams per kilograms (mg / kg) (dose level [DL] 1) and 3.4 mg / kg (DL2). Part 2 is a dose expansion cohort. Once the RP2D has been identified, an expansion cohort will open for enrolment to confirm the safety profile and to evaluate the clinical activity of the combination. Up to 40 evaluable subjects will be enrolled in this two-part study (up to 12 in Part 1, and 28 in Part 2).
Location: 5 locations
To Evaluate Safety, Tolerability, and Clinical Activity of the Antibody-drug Conjugate, GSK2857916 Administered in Combination With Lenalidomide Plus Dexamethasone (Arm A), or in Combination With Bortezomib Plus Dexamethasone (Arm B) in Subjects With Relapsed / Refractory Multiple Myeloma (RRMM)
This is a 2-part study, where Part 1 will be dose-escalation phase and Part 2 will be dose expansion phase. Part 1 will first evaluate the safety and tolerability profile of 2 doses of GSK2857916, when administered in combination with approved regimens of either lenalidomide plus dexamethasone (Arm A) or bortezomib plus dexamethasone (Arm B) and will identify a recommended Phase 2 dose (RP2D) for each combination treatment (Part 1). Part 2 of the study will evaluate the clinical activity at the RP2D for GSK2857916 in combination with lenalidomide plus dexamethasone (Arm A) or bortezomib plus dexamethasone (Arm B) in additional subjects with RRMM. A total of 90 evaluable subjects will be enrolled in the study of which up to 24 will be included in Part 1 and up to 66 will be included in Part 2. Subjects receiving treatment A, may continue combination treatment until the occurrence of PD, intolerable (AEs), consent withdrawal, or death. The subjects receiving treatment B, may continue combination treatment for a total of up to 8 cycles. After 8 cycles of combination therapy, the subjects will continue treatment with GSK2857916, as monotherapy until PD, intolerable AEs, consent withdrawal, or death.
Location: 3 locations