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

NCT ID: NCT05208177

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-22
• Study Completion Date: 2023-08-18

Brief Summary

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.

Conditions

Advanced Solid Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

SHR-1802＋camrelizumab + famitinib

Intervention Type: DRUG

SHR-1802 for injection，q3w； Camrelizumab for injection, q3w; Famitinib malate capsules, qd.

Interventions

SHR-1802＋camrelizumab + famitinib

SHR-1802 for injection，q3w； Camrelizumab for injection, q3w; Famitinib malate capsules, qd.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Tianjin Medical University Cancer Institute&Hospital

Tianjin, Tianjin Municipality, China

Countries

China

Other Identifiers

SHR-1802-II-201

Identifier Type: -

Identifier Source: org_study_id