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NCT05363800 | Recruiting | Recurrent and Refractory Non-Hodgkin's Lymphoma and Multiple Myeloma

Phase I Study of HRS-3738 in Recurrent and Refractory Non-Hodgkin's Lymphoma and Multiple Myeloma
Sponsor:

Jiangsu H鞥R UI medicine co., Ltd.

Brief Summary:

This study is an open-label, multicenter Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of HRS-3738 in patients with recurrent and refractory Non-Hodgkin's lymphoma and multiple myeloma.

Condition or disease

Recurrent and Refractory Non-Hodgkin's Lymphoma and Multiple Myeloma

Intervention/treatment

HRS-3738

Phase

Phase 1

Study Type : Interventional
Estimated Enrollment : 198 participants
Masking : None (Open Label)
Primary Purpose : Treatment
Official Title : Phase I Study of HRS-3738 in Recurrent and Refractory Non-Hodgkin's Lymphoma and Multiple Myeloma
Actual Study Start Date : June 17, 2022
Estimated Primary Completion Date : October 30, 2024
Estimated Study Completion Date : December 30, 2024
Arm Intervention/treatment

Experimental: HRS-3738

In dose Escalation: HRS-3738 will be taken in oral. Seven dose levels are preset. In dose Expansion: 2 to 3 dose cohorts will be selected for dose expansion stage. In indication Expansion: Indications will be selected to evaluate preliminary efficacy.

Drug: HRS-3738
Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • Active multiple myeloma in accordance with IMWG criteria，or histopathologically and immunohistochemically confirmed non-Hodgkin's lymphoma in accordance with the 2016 WHO Classification of lymphoid neoplasias.
  • Recurred or did not alleviate after the previous treatment.
  • Have at least one measurable lesion.
  • With a life expectancy of ≥3 months.
  • Male or female ≥ 18 years old.
  • ECOG performance status of 0-1.
  • Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.
Exclusion Criteria
  • Amyloidosis, plasma cell leukemia.
  • Corrected serum calcium>3.4mmol/L(13.5mg/dl).
  • Presence of metastasis to central nervous system.
  • Treatment of other investigational products.
  • Major surgical therapy within 28 days prior to the date of signature of informed consent form, or expected major surgery during the study.
  • Known history of hypersensitivity to any components of HRS-3738.
  • Other factors that may affect the study results or lead to forced termination of the study early as judged by investigators.
Phase I Study of HRS-3738 in Recurrent and Refractory Non-Hodgkin's Lymphoma and Multiple Myeloma

Location Details

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Phase I Study of HRS-3738 in Recurrent and Refractory Non-Hodgkin's Lymphoma and Multiple Myeloma

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

China, Henan

Henan cancer Hospital

Zhengzhou, Henan, China, 450000

Not yet recruiting

China, Liaoning

Sheng Jing Hospital of China Medical University

Shengyang, Liaoning, China, 110004

Recruiting

China, Zhejiang

Zhejiang University School of Medicine The First Affiliated Hospital

Hangzhou, Zhejiang, China, 310003