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

Phase 1

Recruiting

• Conditions: Recurrent and Refractory Non-Hodgkin's Lymphoma and Multiple Myeloma
• Interventions: Drug: HRS-3738

• Registration Number: NCT05363800
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-04
• Study First Submitted: 2022-04-25
• Study First Submitted QC: 2022-05-05
• Study First Posted: 2022-05-06
• Study Start: 2022-06-17
• Last Update Submitted: 2022-07-27
• Last Update Posted: 2022-07-29
• Primary Completion: 2024-10-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 198

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HRS-3738	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.

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose (MTD)	From Day 1 to Day 28	Incidence and category of dose limiting toxicities (DLTs) during the first 28-day cycle of HRS-3738 treatment.
RP2D	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 Outcome Measures

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

Trial Locations

Locations (3)

Zhejiang University School of Medicine The First Affiliated Hospital; 🇨🇳 Hangzhou, Zhejiang, China

Henan cancer Hospital; 🇨🇳 Zhengzhou, Henan, China

Sheng Jing Hospital of China Medical University; 🇨🇳 Shengyang, Liaoning, China