A Phase 1B/2, Open Label Umbrella Study of Elranatamab (PF-06863135), A B-Cell Maturation Antigen (BCMA) CD3 Bispecific Antibody, in Combination with Other Anti-Cancer Treatments In Participants With Multiple Myeloma
Categories (click each to see list of all clinical trials associated with that category): Myeloma/Plasma Cell Dyscrasia (ONC)
Current Status: Open
Phase: II
Principal Investigator: Holstein, Sarah
Eligibility: https://clinicaltrials.gov/study/NCT05090566?term=NCT05090566&rank=1
Summary
Primary objective: To assess safety and tolerability of PF-06863135 in combination with other anti-cancer therapies in participants with RRMM in order to select a RP2D(s) for the combination.
Secondary Objectives: Phase 1 -To evaluate the overall safety profile. -To evaluate anti-myeloma activity of PF-06863135 in combination with other anti-cancer therapies. -To evaluate the PK of PF-06863135 given alone and in combination with other anti-cancer therapies. Additionally, PK of the combination partner will be evaluated when administered with PF-06863135. -To evaluate immunogenicity of PF-06863135 and combination partner(s) as applicable. Phase 2 -To determine additional efficacy outcomes of PF-06863135 in combination with other anti-cancer therapies. -To further characterize the overall safety profile and tolerability of PF-06863135 in combination with other anti-cancer therapies. -To evaluate PK of PF-06863135 at the RP2D in combination with other anti-cancer therapies. Additionally, to collect PK data of combination partner data when administered with PF-06863135. -To evaluate immunogenicity of PF-06863135 and combination partner(s) as applicable.
Exploratory Objectives: Phase 1-To explore the relationship between PF-06863135 and combination partners and the biology of the participant's MM. -To explore correlations between PF-06863135 exposure and efficacy, safety, and biomarker endpoints, if data allow. Phase 2 -To assess the impact of PF-06863135 on patient-reported symptoms and health-related quality of life. -To explore the relationship between PF-06863135 and combination partners and the biology of the participant's MM. -To explore correlations between PF-06863135 exposure and efficacy, safety and biomarker endpoints, if data allow.