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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. 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. 2. Recurred or did not alleviate after the previous treatment. 3. Have at least one measurable lesion. 4. With a life expectancy of ≥3 months. 5. Male or female ≥ 18 years old. 6. ECOG performance status of 0-1. 7. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.

Exclusion Criteria:

1. Amyloidosis, plasma cell leukemia. 2. Corrected serum calcium>3.4mmol/L(13.5mg/dl). 3. Presence of metastasis to central nervous system. 4. Treatment of other investigational products. 5. Major surgical therapy within 28 days prior to the date of signature of informed consent form, or expected major surgery during the study. 6. Known history of hypersensitivity to any components of HRS-3738. 7. Other factors that may affect the study results or lead to forced termination of the study early as judged by investigators.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05363800
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Jiangsu HengRui Medicine Co., Ltd.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Not yet recruiting
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Recurrent and Refractory Non-Hodgkin's Lymphoma and Multiple Myeloma
Arms & Interventions

Arms

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.

Interventions

Drug: - HRS-3738

HRS-3738 will be administrated per dose level in which the patients are assigned.

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Wenjun Mao

wenjun.mao@hengrui.com

+021-61053363

For additional contact information, you can also visit the trial on clinicaltrials.gov.