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

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.

Study Overview

• Status: Recruiting
• Conditions: Recurrent and Refractory Non-Hodgkin's Lymphoma and Multiple Myeloma
• Intervention / Treatment: Drug: HRS-3738

• Study Type: Interventional
• Enrollment (Anticipated): 198
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Wenjun Mao; Phone Number: +021-61053363; Email: wenjun.mao@hengrui.com

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450000
      • Not yet recruiting
      • Henan Cancer Hospital
  • Liaoning
    • Shengyang, Liaoning, China, 110004
      • Not yet recruiting
      • Sheng Jing Hospital of China Medical University
      • Principal Investigator: Wei Yang
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • Recruiting
      • Zhejiang University School of Medicine The First Affiliated Hospital
      • Principal Investigator: Jie Jing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum tolerated dose (MTD)	Incidence and category of dose limiting toxicities (DLTs) during the first 28-day cycle of HRS-3738 treatment.	From Day 1 to Day 28
RP2D	RP2D will be determined on the basis of evaluation on safety, PK, efficacy data in dose escalation and dose expansion stages.	From Day 1 to Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety endpoints: adverse events(AEs), serious adverse events（SAEs）	Assess safety and tolerability of HRS-3738 by way of adverse events (CTCAE v5.0).	From Day 1 to 30 days after last dose.
Efficacy endpoints: Overall response rate (ORR)	Evaluated using Lugano 2014 criteria and IMWG criteria.	From Day 1 to 30 days after last dose.
Efficacy endpoints: Best of response (BOR)	Evaluated using Lugano 2014 criteria and IMWG criteria	From Day 1 to 30 days after last dose
Efficacy endpoints: time to response (TTR)	Evaluated using Lugano 2014 criteria and IMWG criteria.	From Day 1 to 30 days after last dose.
Efficacy endpoints: Duration of response (DoR)	Evaluated using Lugano 2014 criteria and IMWG criteria	From Day 1 to 30 days after last dose
Efficacy endpoints: Progression-free survival (PFS)	Evaluated using Lugano 2014 criteria and IMWG criteria	From Day 1 to 30 days after last dose
Efficacy endpoints: overall survival (OS).	Evaluated using Lugano 2014 criteria and IMWG criteria.	From Day 1 to 30 days after last dose.
Cmax	Maximal plasma concentration	From Day 1 to 30 days after last dose
Tmax	Time to Cmax	From Day 1 to 30 days after last dose
AUC	Area under the plasma concentration-time curve	From Day 1 to 30 days after last dose
t1/2	Terminal-phase elimination half-life	From Day 1 to 30 days after last dose
Vz/F	Apparent volume of distribution during terminal phase after non-intravenous administration	From Day 1 to 30 days after last dose
CL/F	Apparent total clearance of the drug from plasma after oral administration.	From Day 1 to 30 days after last dose

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2022
• Primary Completion (Anticipated): October 30, 2024
• Study Completion (Anticipated): December 30, 2024

Study Registration Dates

• First Submitted: April 25, 2022
• First Submitted That Met QC Criteria: May 5, 2022
• First Posted (Actual): May 6, 2022

Study Record Updates

• Last Update Posted (Actual): July 29, 2022
• Last Update Submitted That Met QC Criteria: July 27, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Disease Attributes; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Lymphoma; Multiple Myeloma; Neoplasms, Plasma Cell; Recurrence; Lymphoma, Non-Hodgkin
• Other Study ID Numbers: HRS-3738-I-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No