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

Advanced Solid Tumor Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05208177
• Other study ID #: SHR-1802-II-201
• Status: Recruiting
• Phase: Phase 2
• Start date: April 22, 2022
• Est. completion date: December 1, 2024

Study information

• Verified date: January 2022
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: Quanren Wang, Ph.D.
• Phone: 86-021-23511999
• Email: quanren.wang[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 124
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

Intervention

Drug:
• SHR-1802+camrelizumab + famitinib
SHR-1802 for injection,q3w; Camrelizumab for injection, q3w; Famitinib malate capsules, qd.

Locations

Country	Name	City	State
China	Tianjin Medical University Cancer Institute&Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose limiting toxicity (DLT)		4 weeks
Primary	Recommended phase II dose (RP2D)		up to 1 years
Primary	ORR	Objective Response Rate, determined according to RECIST v1.1 criteria	up to 2 years
Secondary	DOR	Duration of Response, determined according to RECIST v1.1 criteria	up to 2 years
Secondary	DCR	Disease Control Rate, determined according to RECIST v1.1 criteria	up to 2 years
Secondary	PFS assessed by investigator	Progression Free Survival, determined according to RECIST v1.1 criteria	up to 2 years
Secondary	TTR	Time to Response,determined according to RECIST v1.1 criteria	up to 2 years
Secondary	OS (overall survival)	From date of treatment start to any cause death or last follow-up	up to 2 years
Secondary	12-month OS rate		from the date of the first dose up to 2 years
Secondary	AEs+SAEs	Adverse Events and Serious Adverse Events assessed by CTCAE v5.0	from the first drug administration to within 90 days for the last drug dose
Secondary	Concentration of drug in serum	Serum concentration of Camrelizumab for Injection and SHR-1802 for injection.	0.5 hour before the first dose up to 30 days after last dose
Secondary	Concentration of drug in plasma	Plasma concentration of Famitinib malate capsule and its metabolite.	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)
Secondary	Count of T lymphocyte subsets	Count of CD4+ T lymphocyte subsets in peripheral blood;Count of CD8+ T lymphocyte subsets in peripheral blood.	30 minutes before the first dose of SHR-1802, the 4th and 8th days after the first injection
Secondary	Percentage of T lymphocyte subsets	Percentage of CD4+ T lymphocyte subsets in peripheral blood;Percentage of CD8+ T lymphocyte subsets in peripheral blood.	30 minutes before the first dose of SHR-1802, the 4th and 8th days after the first injection
Secondary	ADA	Anti-drug antibody of Camrelizumab for Injection and SHR-1802 for injection	up to 30 days after last dose
Secondary	Nab	Neutralizing Antibody of Camrelizumab for Injection and SHR-1802 for injection.	up to 30 days after last dose