A Study of HRS2543 in Patients With Advanced Tumors

A Phase I, Multi-Center, Open Label, Dose Escalation/Expansion Study of HRS2543 in Patients With Advanced Tumors

To assess the safety and tolerability of HRS2543 in patients with advanced tumors and to determine the recommended phase II dose (RP2D) of HRS2543

Study Overview

• Status: Recruiting
• Conditions: Advanced Tumors
• Intervention / Treatment: Drug: HRS2543

• Study Type: Interventional
• Enrollment (Anticipated): 105
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Jie Xie, M.M.; Phone Number: +021-61053363; Email: jie.xie@hengrui.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Recruiting
      • Shanghai Jiao Tong University School of Medicine, Ruijin Hospital
      • Principal Investigator: Jun Zhang, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 18-70 years of age, both male and female
2. non standard treatment, invalid the standard treatment or refuse to receive standard treatment in patients with advanced tumors diagnosed by pathology
3. the Eastern Cooperative Oncology Group （ECOG） General status (performance status, PS) of 0-1
4. the expected lifetime ≥ 3 months
5. Has at least one measurable lesion as defined by RECIST v1.1
6. Written informed consent is provided by signing the informed consent form

Exclusion Criteria:

1. Any previous anti-tumor treatment
2. The toxicity caused by any previous anti-tumor treatment has not recovered to ≤ grade 1
3. Any other anti-tumor treatment is planned during the study treatment
4. After imaging diagnosis, there were brain tumor lesions
5. According to the judgment of the researcher, there are factors that can not swallow, chronic diarrhea and intestinal obstruction or other factors that can significantly affect the absorption, distribution, metabolism or excretion of drugs
6. Active heart disease was present within 6 months before the first administration of the study
7. Other malignancies occurred within 5 years before the first administration of the study
8. Active HBV or HCV infection
9. The subject had a history of immune deficiency
10. According to the judgment of the researcher, there are concomitant diseases that seriously endanger the safety of the subjects, confuse the analysis of the test results, or affect the subjects to complete the study

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: HRS2543	Drug: HRS2543; Dose-escalation part For the dose-escalation study, five dose cohorts (25 mg , 75 mg , 150 mg , 300 mg , and 450 mg ) of HRS2543 are initially set. Dose-expansion part After the completion of dose-escalation study, the dose-expansion study will be carried out at the recommended dose level by the SMC.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose-Limiting Toxicity (DLT)	A DLT is considered at AE related to study drug unless there is a clear, well-documented, alternative explanation for the toxicity. Severity of AEs are graded according to the NCI CTCAE 5.0 for the study, the occurrence of the following drug related AEs during the single dose and the first cycle (28 days) will be considered a DLT by the investigator and SMC.	Day 1 to 28 (Cycle 1)
Maximum Tolerated Dose (MTD)	Toxicity will be evaluated according to the NCI CTCAE Version 5.0.	Day 1 to 28 (Cycle 1)
Recommended PhaseII Dose (RP2D)	Toxicity will be evaluated according to the NCI CTCAE Version 5.0.	Day 1 to 28 (Cycle 1)

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of patients with changes in laboratory measurements	up to 24 months
Number of patients with changes in single and triplicate 12-lead Electrocardiogram (ECG).	up to 24 months
Number of patients with changes in ECOG PS score.	up to 24 months
Number of patients with changes in Physical Examination.	up to 24 months
Number of patients with changes in Vital Signs	up to 24 months
Incidence of adverse events (AEs).	up to 24 months
Cmax of HRS2543 after single dose of HRS2543	Day 1 of Cycle 1(each cycle 28 days)
Tmax of HRS2543 after single dose of HRS2543	Day 1 of Cycle 1(each cycle 28 days)
AUC0-t of HRS2543 after single dose of HRS2543	Day 1 of Cycle 1(each cycle 28 days)
AUC0-∞ of HRS2543 after single dose of HRS2543	Day 1 of Cycle 1(each cycle 28 days)
t1/2 of HRS2543 after single dose of HRS2543	Day 1 of Cycle 1(each cycle 28 days)
Vz/F of HRS2543 after single dose of HRS2543	Day 1 of Cycle 1(each cycle 28 days)
CL/F of HRS2543 after single dose of HRS2543	Day 1 of Cycle 1(each cycle 28 days)
Cmax,ss of HRS2543 after multiple dose administration of HRS2543	Up to 4 cycles (each cycle 28 days)
Tmax,ss of HRS2543 after multiple dose administration of HRS2543	Up to 4 cycles (each cycle 28 days)
Cmin,ss of HRS2543 after multiple dose administration of HRS2543	Up to 4 cycles (each cycle 28 days)
AUCss of HRS2543 after multiple dose administration of HRS2543	Up to 4 cycles (each cycle 28 days)
Rac of HRS2543 after multiple dose administration of HRS2543	Up to 4 cycles (each cycle 28 days)
ORR: the Objective Response Rate	up to 24 months
DoR: the Duration of Response	up to 24 months
DCR: the Disease Control Rate	up to 24 months
PFS: the Progression Free Survival	up to 24 months

Collaborators and Investigators

• Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 28, 2021
• Primary Completion (Anticipated): August 31, 2023
• Study Completion (Anticipated): August 31, 2023

Study Registration Dates

• First Submitted: September 15, 2021
• First Submitted That Met QC Criteria: September 25, 2021
• First Posted (Actual): October 6, 2021

Study Record Updates

• Last Update Posted (Actual): February 7, 2022
• Last Update Submitted That Met QC Criteria: January 21, 2022
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: HRS2543-I-101

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