A Study of SHR-1802 in Patients With Advanced Solid Tumor

Hengrui Medicine

Status and phase: Terminated; Phase 2

Conditions: Advanced Solid Tumor

Treatments: Drug: SHR-1802＋camrelizumab + famitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT05208177

SHR-1802-II-201

Details and patient eligibility

About

To assess the safety and tolerability of SHR-1802 combined with camrelizumab and famitinib in subjects with advanced solid tumor and to determine the dose-limiting toxicity (DLT)，recommended phase II dose (RP2D) and assess objective response rate (ORR) assessed by the investigator based on RECIST v1.1 criteria.

Enrollment: 25 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study;
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
3. Has a life expectancy≥ 3 months;
4. At least one measurable lesion according to RECIST v1.1;
5. Pathologically confirmed advanced solid tumor;
6. Adequate bone marrow reserve and organ function.

Exclusion criteria

1. Have received prior therapy with camrelizumab, and famitinib;
2. Received anti-tumor therapies such as chemotherapy, radiotherapy, biological therapy, targeted therapy, or immunotherapy within 4 weeks before the first dose of the treatment;
3. Underwent a major surgery other than diagnosis or biopsy within 4 weeks before the first dose of the treatment;
4. Have uncontrolled clinically symptomatic pleural effusion, pericardial effusion, or ascites;
5. Have known history of arterial/venous thrombosis within 6 months prior to the first dose of the treatment, such as cerebrovascular accidents, deep vein thrombosis and pulmonary embolism;
6. Grade II-IV cardiac insufficiency as per the New York Heart Association (NYHA) criteria; arrhythmia requiring long-term drug control; unstable angina or acute myocardial infarction within 6 months before the first dose of the treatment;
7. Have other potential factors that may affect the study results or result in the premature discontinuation as determined by the investigator, such as alcoholism, drug abuse, substance abuse, other serious diseases (including mental illness) requiring concomitant treatment, serious laboratory abnormalities, or family or social factors that could affect the safety of medication.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

SHR-1802 for injection combined with Camrelizumab for Injection and Famitinib Malate Capsules

Experimental group

Treatment:

Drug: SHR-1802＋camrelizumab + famitinib