A Study of HRS2543 in Patients With Advanced Tumors

Advanced Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05068856
• Other study ID #: HRS2543-I-101
• Status: Recruiting
• Phase: Phase 1
• Start date: December 28, 2021
• Est. completion date: August 31, 2023

Study information

• Verified date: August 2021
• Source: Shanghai Hengrui Pharmaceutical Co., Ltd.
• Contact: Jie Xie, M.M.
• Phone: +021-61053363
• Email: jie.xie[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Advanced Tumors

Intervention

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.

Locations

Country	Name	City	State
China	Shanghai Jiao Tong University School of Medicine, Ruijin Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Hengrui Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Maximum Tolerated Dose (MTD)	Toxicity will be evaluated according to the NCI CTCAE Version 5.0.	Day 1 to 28 (Cycle 1)
Primary	Recommended PhaseII Dose (RP2D)	Toxicity will be evaluated according to the NCI CTCAE Version 5.0.	Day 1 to 28 (Cycle 1)
Secondary	Number of patients with changes in laboratory measurements		up to 24 months
Secondary	Number of patients with changes in single and triplicate 12-lead Electrocardiogram (ECG).		up to 24 months
Secondary	Number of patients with changes in ECOG PS score.		up to 24 months
Secondary	Number of patients with changes in Physical Examination.		up to 24 months
Secondary	Number of patients with changes in Vital Signs		up to 24 months
Secondary	Incidence of adverse events (AEs).		up to 24 months
Secondary	Cmax of HRS2543 after single dose of HRS2543		Day 1 of Cycle 1(each cycle 28 days)
Secondary	Tmax of HRS2543 after single dose of HRS2543		Day 1 of Cycle 1(each cycle 28 days)
Secondary	AUC0-t of HRS2543 after single dose of HRS2543		Day 1 of Cycle 1(each cycle 28 days)
Secondary	AUC0-8 of HRS2543 after single dose of HRS2543		Day 1 of Cycle 1(each cycle 28 days)
Secondary	t1/2 of HRS2543 after single dose of HRS2543		Day 1 of Cycle 1(each cycle 28 days)
Secondary	Vz/F of HRS2543 after single dose of HRS2543		Day 1 of Cycle 1(each cycle 28 days)
Secondary	CL/F of HRS2543 after single dose of HRS2543		Day 1 of Cycle 1(each cycle 28 days)
Secondary	Cmax,ss of HRS2543 after multiple dose administration of HRS2543		Up to 4 cycles (each cycle 28 days)
Secondary	Tmax,ss of HRS2543 after multiple dose administration of HRS2543		Up to 4 cycles (each cycle 28 days)
Secondary	Cmin,ss of HRS2543 after multiple dose administration of HRS2543		Up to 4 cycles (each cycle 28 days)
Secondary	AUCss of HRS2543 after multiple dose administration of HRS2543		Up to 4 cycles (each cycle 28 days)
Secondary	Rac of HRS2543 after multiple dose administration of HRS2543		Up to 4 cycles (each cycle 28 days)
Secondary	ORR: the Objective Response Rate		up to 24 months
Secondary	DoR: the Duration of Response		up to 24 months
Secondary	DCR: the Disease Control Rate		up to 24 months
Secondary	PFS: the Progression Free Survival		up to 24 months