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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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.

Exclusion Criteria:

  • - 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.
  • - 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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04879043
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Heidelberg Pharma AG
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Germany, Hungary, Poland, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Myeloma, Plasma Cell Disorder
Study Website: View Trial Website
Additional Details

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.

Arms & Interventions

Arms

Experimental: HDP-101

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.

Interventions

Drug: - HDP-101

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Atlanta, Georgia

Status

Recruiting

Address

Winship Cancer Institute of Emory University

Atlanta, Georgia, 30322

Mount Sinai, The Tisch Cancer Instutute, New York, New York

Status

Recruiting

Address

Mount Sinai, The Tisch Cancer Instutute

New York, New York, 10029

MD Anderson Cancer Center, Houston, Texas

Status

Recruiting

Address

MD Anderson Cancer Center

Houston, Texas, 77030

International Sites

Berlin, Germany

Status

Not yet recruiting

Address

Charité - Campus Benjamin Franklin Med. Klinik m.S. Hämatologie, Onkologie

Berlin, , 12203

Chemnitz, Germany

Status

Not yet recruiting

Address

Klinikum Chemnitz gGmbH, Klinik f. Innere Medizin III

Chemnitz, , 09116

Hamburg, Germany

Status

Not yet recruiting

Address

Asklepios Klinik Altona, Haematologie und internistische Onkologie

Hamburg, , 22763

Universitätsklinikum Heidelberg, Heidelberg, Germany

Status

Recruiting

Address

Universitätsklinikum Heidelberg

Heidelberg, , 69120

Universitätsklinikum Schleswig-Holstein, Kiel, Germany

Status

Recruiting

Address

Universitätsklinikum Schleswig-Holstein

Kiel, , 24105

Universitätsklinikum Köln, Köln, Germany

Status

Not yet recruiting

Address

Universitätsklinikum Köln

Köln, , 50937

Lübeck, Germany

Status

Not yet recruiting

Address

UKSH Campus Lübeck Klinik für Hämatologie und Onkologie

Lübeck, , 23538

Universitätsklinikum Mainz, Mainz, Germany

Status

Recruiting

Address

Universitätsklinikum Mainz

Mainz, , 55131

Budapest, Hungary

Status

Not yet recruiting

Address

Semmelweis University, Belgyogyaszati es Onkologiai Klinika

Budapest, , 1083

Budapest, Hungary

Status

Recruiting

Address

National Institute of Oncology, Department of Oncological Internal Medicine

Budapest, , 1122

Pratia Onkologia Katowice, Katowice, Poland

Status

Recruiting

Address

Pratia Onkologia Katowice

Katowice, , 40-519

Szpital Wojewodzki w Opolu, Opole, Poland

Status

Not yet recruiting

Address

Szpital Wojewodzki w Opolu

Opole, , 45-061

Łódź, Poland

Status

Not yet recruiting

Address

Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi

Łódź, , 93-513