Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Clinical Activity of GSK2857916
Complete title: A Phase I Open-label, Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Clinical Activity of the Antibody Drug Conjugate GSK2857916 in Subjects with Relapsed/Refractory Multiple Myeloma and Other Advanced Hematologic Malignancies Expressing BCMA
This study will assess the safety, pharmacokinetic (PK), pharmacodynamic (PD) and the therapeutic potential of GSK2857916 in subjects with multiple myeloma (MM) and other hematologic malignancies that express B cell maturation antigen (BCMA). The hypothesis is that GSK2857916 can be safely administered to subjects with BCMA positive malignancies at doses where target engagement can be demonstrated. This study will determine if adequate target engagement of BCMA receptors translates into clinical benefit for subjects with MM and other BCMA positive hematologic malignancies. The study will consists of two parts: a Part 1 dose escalation phase and a Part 2 expansion phase for safety, and clinical activity testing. The study will enroll a total of approximately 80 subjects with relapsed/refractory MM or other BCMA-expressing hematologic malignancies.
** For Eligibility information, please click on the "Look up trial at NIH" link above. **
Other eligibility criteria may apply.
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Hematologic Malignancies; Lymphoproliferative Disorders; Multiple Myeloma (MM); Immunoproliferative Disorders; Immunotherapy
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