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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
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515273-10-00
Acronym
HDP-101-01
Enrollment
89
Registered
2024-08-23
Start date
2021-10-19
Completion date
Unknown
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsed or refractory Multiple Myeloma (r/r MM)

Brief summary

Phase 1: Number of patients who experience a dose-limiting toxicity (DLT) during the first cycle of treatment. Phase 2a: Objective response rate (ORR).

Interventions

Sponsors

Heidelberg Pharma AG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Phase 1: Number of patients who experience a dose-limiting toxicity (DLT) during the first cycle of treatment. Phase 2a: Objective response rate (ORR).

Countries

Germany, Hungary, Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026