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NCT Number: NCT05363800

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.

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This study is active but is not currently recruiting participants.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

HRS-3738

Drug

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

Primary outcomes

  1. Maximum tolerated dose (MTD)

    Time frame: From Day 1 to Day 28

    Incidence and category of dose limiting toxicities (DLTs) during the first 28-day cycle of HRS-3738 treatment.

  2. RP2D

    Time frame: From Day 1 to Day 28

    RP2D will be determined on the basis of evaluation on safety, PK, efficacy data in dose escalation and dose expansion stages.

Secondary outcomes

  1. Safety endpoints: adverse events(AEs), serious adverse events(SAEs)

    Time frame: From Day 1 to 30 days after last dose.

    Assess safety and tolerability of HRS-3738 by way of adverse events (CTCAE v5.0).

  2. Efficacy endpoints: Overall response rate (ORR)

    Time frame: From Day 1 to 30 days after last dose.

    Evaluated using Lugano 2014 criteria and IMWG criteria.

  3. Efficacy endpoints: Best of response (BOR)

    Time frame: From Day 1 to 30 days after last dose

    Evaluated using Lugano 2014 criteria and IMWG criteria

  4. Efficacy endpoints: time to response (TTR)

    Time frame: From Day 1 to 30 days after last dose.

    Evaluated using Lugano 2014 criteria and IMWG criteria.

  5. Efficacy endpoints: Duration of response (DoR)

    Time frame: From Day 1 to 30 days after last dose

    Evaluated using Lugano 2014 criteria and IMWG criteria

  6. Efficacy endpoints: Progression-free survival (PFS)

    Time frame: From Day 1 to 30 days after last dose

    Evaluated using Lugano 2014 criteria and IMWG criteria

  7. Efficacy endpoints: overall survival (OS).

    Time frame: From Day 1 to 30 days after last dose.

    Evaluated using Lugano 2014 criteria and IMWG criteria.

  8. Cmax

    Time frame: From Day 1 to 30 days after last dose

    Maximal plasma concentration

  9. Tmax

    Time frame: From Day 1 to 30 days after last dose

    Time to Cmax

  10. AUC

    Time frame: From Day 1 to 30 days after last dose

    Area under the plasma concentration-time curve

  11. t1/2

    Time frame: From Day 1 to 30 days after last dose

    Terminal-phase elimination half-life

  12. Vz/F

    Time frame: From Day 1 to 30 days after last dose

    Apparent volume of distribution during terminal phase after non-intravenous administration

  13. CL/F

    Time frame: From Day 1 to 30 days after last dose

    Apparent total clearance of the drug from plasma after oral administration.

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
May 6, 2022
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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