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

NCT05208177 | Terminated Phase 2

• 1 other identifier: SHR-1802-II-201
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Dose limiting toxicity (DLT)

  4 weeks

• Recommended phase II dose (RP2D)

  up to 1 years

• ORR

  Objective Response Rate, determined according to RECIST v1.1 criteria

  up to 2 years

Secondary Outcomes (13)

• DOR

  up to 2 years

• DCR

  up to 2 years

• PFS assessed by investigator

  up to 2 years

• TTR

  up to 2 years

• OS (overall survival)

  up to 2 years

Study Arms (1)

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

EXPERIMENTAL

Drug: SHR-1802＋camrelizumab + famitinib

Interventions

SHR-1802＋camrelizumab + famitinib DRUG

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

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Have received prior therapy with camrelizumab, and famitinib;
• Received anti-tumor therapies such as chemotherapy, radiotherapy, biological therapy, targeted therapy, or immunotherapy within 4 weeks before the first dose of the treatment;
• Underwent a major surgery other than diagnosis or biopsy within 4 weeks before the first dose of the treatment;
• Have uncontrolled clinically symptomatic pleural effusion, pericardial effusion, or ascites;
• 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;
• 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;
• 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.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Tianjin Medical University Cancer Institute&Hospital

Tianjin, Tianjin Municipality, 300202, China

Location

MeSH Terms

Interventions

famitinib

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Dose-escalation: Traditional 3+3 dose-escalation design. Dose-expansion: 10 to 12 subjects (included subjects of the dose-escalation part) will be enrolled in each tolerable dose level. Efficacy-expansion: After determination of the recommended dose for Phase II (RP2D), selected cohorts with different tumor types will be expanded.

Study Record Dates

• First Submitted: January 18, 2022
• First Posted: January 26, 2022
• Study Start: April 22, 2022
• Primary Completion: August 18, 2023
• Study Completion: August 18, 2023
• Last Updated: August 22, 2025

Record last verified: 2025-08

Locations

CN (1)