Clinical trial NCT05208177: A Study of SHR-1802 in Patients With Advanced Solid Tumor
Official title: A Phase Ⅰb/Ⅱ Dose-exploration and Efficacy-expansion Study of SHR-1802 Combined With Camrelizumab for Injection and Famitinib Malate Capsules for the Treatment of Advanced Solid Tumor
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Advanced Solid Tumor
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-01-26
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Dose limiting toxicity (DLT)
timeFrame: 4 weeks
measure: Recommended phase II dose (RP2D)
timeFrame: up to 1 years
measure: ORR
timeFrame: up to 2 years
Secondary outcomes:
measure: DOR
timeFrame: up to 2 years
measure: DCR
timeFrame: up to 2 years
measure: PFS assessed by investigator
timeFrame: up to 2 years
measure: TTR
timeFrame: up to 2 years
measure: OS (overall survival)
timeFrame: up to 2 years
measure: 12-month OS rate
timeFrame: from the date of the first dose up to 2 years
measure: AEs+SAEs
timeFrame: from the first drug administration to within 90 days for the last drug dose
measure: Concentration of drug in serum
timeFrame: 0.5 hour before the first dose up to 30 days after last dose
measure: Concentration of drug in plasma
timeFrame: n the second cycle，predose 1 hour and 6 hours post-dose；In cycle 3, cycle 4, cycle 6, cycle 8, and cycle 10，predose 1 hour（each cycle is 21 days）
measure: Count of T lymphocyte subsets
timeFrame: 30 minutes before the first dose of SHR-1802, the 4th and 8th days after the first injection
measure: Percentage of T lymphocyte subsets
timeFrame: 30 minutes before the first dose of SHR-1802, the 4th and 8th days after the first injection
measure: ADA
timeFrame: up to 30 days after last dose
measure: Nab
timeFrame: up to 30 days after last dose
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute&Hospital
state: Tianjin
Study officials:
References: