Tests HDP-101 safety in Chinese patients with relapsed multiple myeloma
Tests the drug HDP-101 in Chinese adults whose multiple myeloma has returned or not responded.
Plain-language title generated from the registry record
Registry title: Study to Assess Safety and Efficacy of HDP-101 in Chinese Patients With Relapsed or Refractory Multiple Myeloma
Key facts
- Where
- Beijing, Hangzhou, Jinan, Suzhou, and Tianjin, ChinaSee the 5 sites
- Phase
- Phase 1
Where in China
- Beijing Chao-Yang Hospital, Capital Medical UniversityBeijing, ChinaTaking people
- The First Affiliated Hospital Zhejiang University School of MedicineHangzhou, ChinaNot yet recruiting
- Qilu Hospital of Shandong UniversityJinan, ChinaTaking people
- The First Affiliated Hospital of Soochow UniversitySuzhou, ChinaTaking people
- Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical SciencesTianjin, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
- Trial code
- NCT07529782
- Record updated
- 14 April 2026
- Original description
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.Read full original descriptionShow less
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HDP-101 in Chinese Patients With Plasma Cell Disorders Including Multiple Myeloma
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.
Inclusion: 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: 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 congestive heart failure; 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; Pneumonia or symptomatic pneumonitis; Known central nervous system involvement; Plasma cell leukemia; Pregnancy or breast feeding.