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

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

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 design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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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