Study to Assess Safety of HDP-101 in Patients With Relapsed Refractory Multiple Myeloma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04879043|
Recruitment Status : Not yet recruiting
First Posted : May 10, 2021
Last Update Posted : May 10, 2021
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma Plasma Cell Disorder||Drug: HDP-101||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||78 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||
Eligible patients will be enrolled and treated with intravenous HDP-101 every 3 weeks.
A Bayesian logistic regression model will be used to guide dose-escalation during Phase 1 and select the best dose for the Phase 2a of the study.
|Masking:||None (Open Label)|
|Official Title:||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|
|Estimated Study Start Date :||May 2021|
|Estimated Primary Completion Date :||August 2024|
|Estimated Study Completion Date :||May 2025|
Participants will receive HDP-101 intravenously at one dose every 3 weeks (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.
HDP-101 is available as lyophilized white powder for preparation of infusion.
- 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) ]
- Objective response rate (ORR) [ Time Frame: Through study completion, an average of 1 year ]Proportion of enrolled subjects who achieve a partial response (PR) or better, i.e. stringent complete response (sCR), complete response (CR), very good partial response (VGPR) and PR, according to the IMWG criteria.
- Assess the safety and tolerability of HDP-101 [ Time Frame: Through study completion, an average of 1 year ]Number of patients with serious and non-serious adverse events grouped by system organ class and preferred terms based on Common Terminology Criteria for Adverse Events (CTCAE v 5.0) classification.
- To assess the anticancer activity of HDP-101 in terms of time-to-event (TTE) [ Time Frame: Through study completion, an average of 1 year ]Clinical efficacy of HDP-101 measured by Progression Free Survival (PFS) and Overall Survival (OS).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04879043
|Contact: András Strassz, MD||+ 49 6203 1009 email@example.com|
|United States, Georgia|
|Winship Cancer Institute of Emory University|
|Atlanta, Georgia, United States, 30322|
|United States, New York|
|Mount Sinai, The Tisch Cancer Instutute|
|New York, New York, United States, 10029|
|United States, Texas|
|MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Heidelberg, Germany, 69120|