A Study of HRS2543 in Patients With Advanced Tumors

Phase 1

Terminated

• Conditions: Advanced Tumors
• Interventions: Drug: HRS2543

• Registration Number: NCT05068856
• Lead Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-15
• Study First Submitted QC: 2021-09-25
• Study First Posted: 2021-10-06
• Study Start: 2021-12-28
• Primary Completion: 2024-05-15
• Study Completion: 2024-05-15
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-16
• Last Update Posted: 2024-07-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HRS2543	HRS2543	-

Primary Outcome Measures

Name	Time	Method
Dose-Limiting Toxicity (DLT)	Day 1 to 28 (Cycle 1)	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.
Maximum Tolerated Dose (MTD)	Day 1 to 28 (Cycle 1)	Toxicity will be evaluated according to the NCI CTCAE Version 5.0.
Recommended PhaseII Dose (RP2D)	Day 1 to 28 (Cycle 1)	Toxicity will be evaluated according to the NCI CTCAE Version 5.0.

Secondary Outcome Measures

Name	Time	Method
PFS: the Progression Free Survival	up to 24 months
Number of patients with changes in laboratory measurements	up to 24 months
Cmax 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)
Tmax,ss of HRS2543 after multiple dose administration of HRS2543	Up to 4 cycles (each cycle 28 days)
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
Cmin,ss 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)
DoR: the Duration of Response	up to 24 months
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)
AUCss 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
DCR: the Disease Control Rate	up to 24 months
Incidence of adverse events (AEs).	up to 24 months
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)
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)

Trial Locations

Locations (1)

Shanghai Jiao Tong University School of Medicine, Ruijin Hospital; 🇨🇳 Shanghai, Shanghai, China