A Study of HRS2543 in Patients With Advanced Tumors

Hengrui Medicine

Status and phase: Terminated; Phase 1

Conditions: Advanced Tumors

Treatments: Drug: HRS2543

Study type: Interventional

Funder types: Industry

Identifiers

NCT05068856

HRS2543-I-101

Details and patient eligibility

About

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

Enrollment: 10 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

HRS2543

Experimental group

Treatment:

Drug: HRS2543