NCT05363800

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P75+ for phase_1

Timeline
6mo left

Started Jun 2022

Longer than P75 for phase_1

Geographic Reach
1 country

3 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
Jun 2022Dec 2026

First Submitted

Initial submission to the registry

April 25, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 6, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

June 17, 2022

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

June 5, 2026

Status Verified

June 1, 2026

Enrollment Period

4.5 years

First QC Date

April 25, 2022

Last Update Submit

June 4, 2026

Conditions

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

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (13)

  • Safety endpoints: adverse events(AEs), serious adverse events（SAEs）

    From Day 1 to 30 days after last dose.

  • Efficacy endpoints: Overall response rate (ORR)

    From Day 1 to 30 days after last dose.

  • Efficacy endpoints: Best of response (BOR)

    From Day 1 to 30 days after last dose

  • Efficacy endpoints: time to response (TTR)

    From Day 1 to 30 days after last dose.

  • Efficacy endpoints: Duration of response (DoR)

    From Day 1 to 30 days after last dose

  • +8 more secondary outcomes

Study Arms (1)

HRS-3738

EXPERIMENTAL

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

Interventions

HRS-3738DRUG

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

HRS-3738

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Henan cancer Hospital

Zhengzhou, Henan, 450000, China

Location

Sheng Jing Hospital of China Medical University

Shengyang, Liaoning, 110004, China

Location

Zhejiang University School of Medicine The First Affiliated Hospital

Hangzhou, Zhejiang, 310003, China

Location

MeSH Terms

Conditions

RecurrenceLymphoma, Non-HodgkinMultiple Myeloma

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemorrhagic Disorders

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single arm study of HRS-3738
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2022

First Posted

May 6, 2022

Study Start

June 17, 2022

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

June 5, 2026

Record last verified: 2026-06

Locations

CN(3)