HDP-101
Study to Assess Safety of HDP-101 in Patients With Relapsed Refractory Multiple Myeloma
What will happen during the trial?
The study will consists of two parts: a Part 1 dose escalation phase and a Part 2a expansion phase for safety, tolerability, PK, PD, and clinical activity testing. The study will enroll subjects with relapsed/refractory MM or other plasma cell disorders expressing BCMA. An adaptive 2-parameter Bayesian logistic regression model (BLRM) for dose-escalation with overdose control will be used in the dose-escalation phase for determination of the MTD or the RP2D. Dose-expansion phase of the study aims to collect preliminary evidence of antitumor activity and to confirm the safety of the HDP-101 as a monotherapy.
More Information
- Trial Status
- Accepting patients
- Trial Phase
- Phase 1/2
- Enrollment
- 78 patients (estimated)
- Sponsors
- Heidelberg Pharma
- Tags
- Antibody Drug Conjugate (ADC), B-Cell Maturation Antigen (BCMA)
- Trial Type
- Treatment
- Last Update
- SparkCures ID
- 1177
- NCT Identifier
- NCT04879043
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