HDP-101: HDP-101 is available as lyophilized white powder for preparation of infusion.
Study summary
This study is a 2-part study with a dose-escalation part and a dose-expansion part. The aim of the dose-escalation part is to determine the maximum tolerated dose (MTD) and/or establish the recommended Phase 2 dose (RP2D) in the Chinese population, in order to select the treatment dose for the dose-expansion part. The dose-escalation part will be followed by the dose-expansion part once the MTD(s) and/or RP2D of HDP-101 monotherapy in the Chinese population have been determined. The dose-expansion part of the study is intended to collect preliminary evidence of antitumor activity and to confirm the safety of the HDP-101 as monotherapy in Chinese patients with r/r MM.
Eligibility
Sex
ALL
Min age
—
Max age
18 Years
Healthy volunteers
No
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 (Dose-escalation part only: patients with non-secretory or oligo-secretory myeloma (NSMM) not meeting the measurability criteria are eligible).
* Adequate organ system function as defined in protocol.
Exclusion Criteria:
* 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 therapy.
* Patients with positive hepatitis B virus (HBV) infection or positive hepatitis C virus (HCV) infection.
* Current active liver or biliary disease.
* Pregnancy or breast feeding.
* Pneumonia or symptomatic pneumonitis.
Primary outcome measure(s)
Number of patients who experience a dose-limiting toxicity (DLT) during the first cycle of treatment. — Up to Day 21 (from first dose)
Trial sites (5)
Facility
City
Region
Status
Beijing Chao-Yang Hospital, Capital Medical University
Beijing
Beijing Municipality
Recruiting
The First Affiliated Hospital of Soochow University
Suzhou
Jiangsu
Recruiting
Qilu Hospital of Shandong University
Jinan
Shandong
Recruiting
Institute of Hematology & Blood Diseases Hospital,Chinese Academy of Medical Sciences
Tianjin
Tianjin Municipality
Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou
Zhejiang
Not Yet Recruiting
More Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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