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

NCT ID: NCT05363800

Last Updated: 2022-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

198 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-17

Study Completion Date

2024-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single arm study of HRS-3738
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

HRS-3738

Intervention Type DRUG

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

Interventions

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HRS-3738

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Henan cancer Hospital

Zhengzhou, Henan, China

Site Status NOT_YET_RECRUITING

Sheng Jing Hospital of China Medical University

Shengyang, Liaoning, China

Site Status NOT_YET_RECRUITING

Zhejiang University School of Medicine The First Affiliated Hospital

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wenjun Mao

Role: CONTACT

+021-61053363

Other Identifiers

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HRS-3738-I-102

Identifier Type: -

Identifier Source: org_study_id

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