Multiple MyelomaPhase 1/2NCT04879043
Study to Assess Safety of HDP-101 in Patients With Relapsed Refractory Multiple Myeloma
A Phase 1/2 study testing HDP-101 in people with Multiple Myeloma and Plasma Cell Disorder, run by Heidelberg Pharma AG at 24 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Plasma Cell Disorder
- What is being tested?
- HDP-101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 24 sitesin 5 countries
- Study dates
- 7 Feb 2022to Sep 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged ≥18 years.
- Life expectancy >12 weeks.
- Eastern Cooperative Oncology Group Performance Status (PS) of 0 to 2.
- A confirmed diagnosis of active MM according to the diagnostic criteria established by the International Myeloma Working Group (IMWG).
- Must have undergone SCT or is considered transplant ineligible.
- Must have undergone prior treatments with antimyeloma therapy which must have included an immunomodulatory drug, proteasome inhibitor, and anti-CD38 treatment, alone or in combination. In addition, the patient should either refractory or intolerant to any established standard of care therapy providing a meaningful clinical benefit for the patient assessed by the Investigator.
- Measurable disease as per IMWG criteria.
- Adequate organ system function as defined in protocol.
Who cannot join
- For patient entering the Phase 2a part only: Prior treatment with any approved or experimental BCMA-targeting modalities are not allowed.
- Known central nervous system involvement.
- Plasma cell leukemia.
- History of congestive heart failure.
- Autologous or allogenic SCT within 12 weeks before the first infusion or is planning for autologous SCT.
- Symptomatic graft versus host disease post allogenic hemopoietic cell transplant within 12 months prior to the first study treatment infusion.
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- Radiotherapy within 21 days prior to the first study treatment infusion.
- History of any other malignancy known to be active.
- Known human immunodeficiency virus infection.
- Patients with active infection requiring systemic anti-infective.
- Patients with positive test results for hepatitis B surface antigen or Hepatitis B core antigen.
- Patients with positive test results for hepatitis C virus (HCV) infection.
- Current active liver or biliary disease.
Trial locations and contacts
24 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
24 sites in 5 countries
Germany8 sites
- Withdrawn
Charité - Campus Benjamin Franklin Med. Klinik m.S. Hämatologie, Onkologie
Berlin, 12203
- Withdrawn
Klinikum Chemnitz gGmbH, Klinik f. Innere Medizin III
Chemnitz, 09116
- Withdrawn
Universitätsklinikum Köln
Cologne, 50937
- Withdrawn
Asklepios Klinik Altona, Haematologie und internistische Onkologie
Hamburg, 22763
- Active, not recruiting
Universitätsklinikum Heidelberg
Heidelberg, 69120
- Withdrawn
Universitätsklinikum Schleswig-Holstein
Kiel, 24105
- Active, not recruiting
UKSH Campus Lübeck Klinik für Hämatologie und Onkologie
Lübeck, 23538
- Withdrawn
Universitätsklinikum Mainz
Mainz, 55131
Poland6 sites, 4 recruiting
- Recruiting
Pratia Onkologia Katowice
Katowice, 40-568
- Recruiting
Pratia Onkologia Kraków
Krakow, 40-519
- Withdrawn
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
Lodz, 93-513
- Withdrawn
Szpital Wojewodzki w Opolu
Opole, 45-061
- Recruiting
AIDPORT Sp. zo.o.
Skórzewo, 60-185
- Recruiting
MICS Centrum Medyczne Torun
Torun, 87-100
United States5 sites, 5 recruiting
- Recruiting
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
- Not yet recruiting
Norton Healthcare, Inc.
Louisville, Kentucky, 40202
- Recruiting
Mount Sinai, The Tisch Cancer Instutute
New York, New York, 10029
- Recruiting
Nebraska Cancer Institute
Omaha, Nebraska, 68130
Hungary3 sites, 2 recruiting
- Recruiting
Semmelweis University, Belgyogyaszati es Onkologiai Klinika
Budapest, 1083
- Withdrawn
National Institute of Oncology, Department of Oncological Internal Medicine
Budapest, 1122
- Not yet recruiting
Pécsi Tudományegyetem Klinikai Központ
Pécs, 7624
Romania2 sites, 2 recruiting
- Recruiting
Arensia Clinics SRL
Bucharest
- Recruiting
Oncology Institute Prof. Dr. Ion Chiricuta I.O.C.N.
Cluj-Napoca
About this study
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
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.
Read the 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
- Being tested
- HDP-101
- Medical subject headings
- Multiple Myeloma, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HDP-101Drug
HDP-101 is available as lyophilized white powder for preparation of infusion.
| Study group | Role | What they receive |
|---|---|---|
| HDP-101 | Experimental | 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. Receives: Drug: HDP-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who experience dose-limiting toxicity (DLT) during the first cycle of treatment - Part 1 as defined in Clinical Study Protocol
Measured: Up to Day 21 (from first dose)
Objective response rate (ORR)
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.
Measured: Through study completion, an average of 1 year
Secondary outcomes (2)
Assess the safety and tolerability of HDP-101
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.
Measured: Through study completion, an average of 1 year
To assess the anticancer activity of HDP-101 in terms of time-to-event (TTE)
Clinical efficacy of HDP-101 measured by Progression Free Survival (PFS) and Overall Survival (OS).
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2021
- Study start7 Feb 2022
- Primary completionMar 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Eligible patients will be enrolled and treated with intravenous HDP-101 every 3 weeks. In Phase 1 dose-escalation part from Cohort 6 additional treatment arms are introduced for dose-optimization purposes with dosing every 3 weeks, split dosing weekly or split dosing in the first cycle on Day1 and Day8. 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)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heidelberg Pharma AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04879043
- Sponsor's protocol ID
- HDP-101-01
- Status last verified
- Sep 2026
- First submitted
- 23 Apr 2021
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Strassz A, Raab MS, Orlowski RZ, Kulke M, Schiedner G, Pahl A. A First in Human Study Planned to Evaluate HDP-101, an Anti-BCMA Amanitin Antibody-Drug Conjugate with a New Payload and a New Mode of Action, in Multiple Myeloma. Blood 2020; 136 (Supplement 1): 34. doi: https://doi.org/10.1182/blood-2020-142285
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04879043
- Acronym / sponsor ID
- HDP-101-01
- Conditions
- Multiple Myeloma, Plasma Cell Disorder
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Heidelberg Pharma AGIndustry (pharma, biotech, devices)
- Study start
- 7 Feb 2022 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 10 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Eligible patients will be enrolled and treated with intravenous HDP-101 every 3 weeks. In Phase 1 dose-escalation part from Cohort 6 additional treatment arms are introduced for dose-optimization purposes with dosing every 3 weeks, split dosing weekly or split dosing in the first cycle on Day1 and Day8. 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.
| Arm | Type | Receives |
|---|---|---|
| HDP-101 | Experimental | Drug: HDP-101Participants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female aged ≥18 years.
- Life expectancy >12 weeks.
- Eastern Cooperative Oncology Group Performance Status (PS) of 0 to 2.
- A confirmed diagnosis of active MM according to the diagnostic criteria established by the International Myeloma Working Group (IMWG).
- Must have undergone SCT or is considered transplant ineligible.
Key exclusion criteria (13 listed)
- For patient entering the Phase 2a part only: Prior treatment with any approved or experimental BCMA-targeting modalities are not allowed.
- Known central nervous system involvement.
- Plasma cell leukemia.
- History of congestive heart failure.
- Autologous or allogenic SCT within 12 weeks before the first infusion or is planning for autologous SCT.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HDP-101HDP-101 is available as lyophilized white powder for preparation of infusion. | Drug | HDP-101 |
Primary outcome
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.
2 secondary outcomes
Assess the safety and tolerability of HDP-101
Time frame: Through study completion, an average of 1 year
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- BackgroundStrassz A, Raab MS, Orlowski RZ, Kulke M, Schiedner G, Pahl A. A First in Human Study Planned to Evaluate HDP-101, an Anti-BCMA Amanitin Antibody-Drug Conjugate with a New Payload and a New Mode of Action, in Multiple Myeloma. Blood 2020; 136 (Supplement 1): 34. doi: https://doi.org/10.1182/blood-2020-142285
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
24 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing HDP-101 in people with Multiple Myeloma and Plasma Cell Disorder, run by Heidelberg Pharma AG at 24 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Germany, Poland, United States, Hungary, Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lei Wang, MD (+ 49 6203 1009 0, clinical@hdpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04879043, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.