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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumor
• Intervention / Treatment: Drug: SHR-1802＋camrelizumab + famitinib

• Study Type: Interventional
• Enrollment (Anticipated): 124
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Quanren Wang, Ph.D.; Phone Number: 86-021-23511999; Email: quanren.wang@hengrui.com
• Study Contact Backup: Name: Liang Hu, P.M; Phone Number: 18036618148; Email: liang.hu@hengrui.com

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300202
      • Recruiting
      • Tianjin Medical University Cancer Institute＆Hospital
      • Principal Investigator: Jihui Hao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: SHR-1802 for injection combined with Camrelizumab for Injection and Famitinib Malate Capsules	Drug: SHR-1802＋camrelizumab + famitinib; SHR-1802 for injection，q3w； Camrelizumab for injection, q3w; Famitinib malate capsules, qd.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
DOR	Duration of Response, determined according to RECIST v1.1 criteria	up to 2 years
DCR	Disease Control Rate, determined according to RECIST v1.1 criteria	up to 2 years
PFS assessed by investigator	Progression Free Survival, determined according to RECIST v1.1 criteria	up to 2 years
TTR	Time to Response，determined according to RECIST v1.1 criteria	up to 2 years
OS (overall survival)	From date of treatment start to any cause death or last follow-up	up to 2 years
12-month OS rate		from the date of the first dose up to 2 years
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
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
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）
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
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
ADA	Anti-drug antibody of Camrelizumab for Injection and SHR-1802 for injection	up to 30 days after last dose
Nab	Neutralizing Antibody of Camrelizumab for Injection and SHR-1802 for injection.	up to 30 days after last dose

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 22, 2022
• Primary Completion (ANTICIPATED): December 1, 2023
• Study Completion (ANTICIPATED): December 1, 2024

Study Registration Dates

• First Submitted: January 18, 2022
• First Submitted That Met QC Criteria: January 25, 2022
• First Posted (ACTUAL): January 26, 2022

Study Record Updates

• Last Update Posted (ACTUAL): May 27, 2022
• Last Update Submitted That Met QC Criteria: May 25, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: SHR-1802-II-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No