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

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Heidelberg Pharma AG
Study ID
NCT04879043
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • HDP-101 — DRUG
    HDP-101 is available as lyophilized white powder for preparation of infusion.

Study Details

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.

Key Dates

Start date
Feb 7, 2022
Status verified
Jul 2024
Primary completion
Aug 31, 2025
Completion
May 31, 2026

Study Design

Enrollment
78 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: HDP-101
    Participants will receive HDP-101 intravenously in a 21 day cycle until disease progression, intolerable toxicity, Investigator's discretion or patient withdrawal. During the phase 1 tolerability of different dose levels will be evaluated. During the phase 2a dose expansion part the recommended phase 2 dose (RP2D) of HDP-101 will be administered.

Primary Outcome Measure

Number of patients who experience dose-limiting toxicity (DLT) during the first cycle of treatment - Part 1 as defined in Clinical Study Protocol [ Time Frame: Up to Day 21 (from first dose) ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Winship Cancer Institute of Emory UniversityAtlantaGeorgia30322-
Mount Sinai, The Tisch Cancer InstututeNew YorkNew York10029-
MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Atlanta, GA

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Winship Cancer Institute of Emory University· Atlanta, GAMount Sinai, The Tisch Cancer Instutute· New York, NYMD Anderson Cancer Center· Houston, TX

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