NCT04879043

Study to Assess Safety of HDP-101 in Patients With Relapsed Refractory Multiple Myeloma

A Phase 1/2a, First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HDP-101 in Patients With Plasma Cell Disorders Including Multiple Myeloma

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 78 (estimated)
• Sponsor: Heidelberg Pharma AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will assess the safety, tolerability, pharmacokinetics (PK) and the therapeutic potential of HDP-101 in patients with plasma cell disorders including multiple myeloma.

Detailed description

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.

Conditions

• Multiple Myeloma
• Plasma Cell Disorder

Interventions

Type	Name	Description
DRUG	HDP-101	HDP-101 is available as lyophilized white powder for preparation of infusion.

Timeline

• Start date: 2022-02-07
• Primary completion: 2025-08-01
• Completion: 2026-05-01
• First posted: 2021-05-10
• Last updated: 2024-07-24

Locations

16 sites across 4 countries: United States, Germany, Hungary, Poland

Regulatory

• FDA-regulated drug study