HDP-101 for relapsed or refractory multiple myeloma in Chinese patients

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 trial will try HDP-101 to see if it is safe and can help control relapsed or refractory multiple myeloma in Chinese adults.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: N/A to 18 Years
• Sex: All
• Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. (Industry-sponsored)
• Locations: 5 sites (Beijing, Beijing Municipality and 4 other locations)
• Trial ID: NCT07529782 on ClinicalTrials.gov

What this trial studies

This is a two-part Phase 1 study of HDP-101 given as monotherapy in Chinese adults with relapsed or refractory multiple myeloma. The first part uses dose escalation to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) in the Chinese population. Once the MTD/RP2D is determined, a dose-expansion cohort will enroll additional patients to collect preliminary evidence of antitumor activity and further characterize safety. Eligible patients are adults who have received prior immunomodulatory, proteasome inhibitor, and anti-CD38 therapies and have measurable or certain non-secretory disease.

Who should consider this trial

Good fit: Adults (≥18 years) with relapsed or refractory multiple myeloma who have received prior IMiD, proteasome inhibitor, and anti-CD38 therapy, have ECOG 0–2, life expectancy >12 weeks, and adequate organ function are the ideal candidates.

Not a fit: Patients who are newly diagnosed, who have not received the required prior therapies, who have poor organ function or active uncontrolled infections, or who cannot attend visits at the Chinese study sites are unlikely to benefit from participating.

Why it matters

Potential benefit: If successful, HDP-101 could provide a new treatment option for heavily pretreated Chinese patients with relapsed or refractory multiple myeloma.

How similar studies have performed: Other BCMA-targeted and novel myeloma therapies have shown clinical activity in relapsed/refractory disease, but HDP-101's exact construct is relatively novel and clinical evidence is still limited.

Eligibility 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 (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.

Where this trial is running

Beijing, Beijing Municipality and 4 other locations

• Beijing Chao-Yang Hospital, Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)
• The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (Recruiting)
• Qilu Hospital of Shandong University — Jinan, Shandong, China (Recruiting)
• Institute of Hematology & Blood Diseases Hospital,Chinese Academy of Medical Sciences — Tianjin, Tianjin Municipality, China (Recruiting)
• The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Jianfei Zhao

Conditions Multiple Myeloma and Other Plasma Cell Neoplasms; multiple myeloma; myeloma