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

Hengrui Medicine logo

Hengrui Medicine

Status and phase

Enrolling
Phase 1

Conditions

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

Treatments

Drug: HRS-3738

Study type

Interventional

Funder types

Industry

Identifiers

NCT05363800
HRS-3738-I-102

Details and patient eligibility

About

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.

Enrollment

198 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

198 participants in 1 patient group

HRS-3738
Experimental group
Description:
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.
Treatment:
Drug: HRS-3738

Trial contacts and locations

3

Loading...

Central trial contact

Wenjun Mao

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems