- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04679038
A Trial of SHR-1701 in Combination With Famitinib in Patients With Advanced Solid Tumors
SHR-1701 Plus Famitinib Malate in Advanced Solid Tumors: An Open-label, Multi-center, Phase I/II Trial
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Linna Wang, MD
- Phone Number: +86 13581990612
- Email: linna.wang@hengrui.com
Study Contact Backup
- Name: Lu Wang, PhD
- Phone Number: +86 13472607033
- Email: lu.wang@hengrui.com
Study Locations
-
-
Anhui
-
Hefei, Anhui, China, 230001
- Active, not recruiting
- Anhui Provincial Hospital
-
Hefei, Anhui, China, 230601
- Recruiting
- The 2nd affiliated hospital of Anhui Medical University
-
Principal Investigator:
- Zhendong Chen, Doctor
-
-
Beijing
-
Beijing, Beijing, China, 100142
- Recruiting
- Beijing Cancer Hospital
-
Principal Investigator:
- Xu Zhu, Doctor
-
-
Heilongjiang
-
Harbin, Heilongjiang, China, 150000
- Recruiting
- Harbin Medical University Cancer Hospital
-
-
Henan
-
Zhengzhou, Henan, China, 450052
- Recruiting
- The First Affiliated Hospital of Zhengzhou University
-
Principal Investigator:
- Yanru Qin, Doctor
-
Zhengzhou, Henan, China, 450003
- Active, not recruiting
- Henan Cancer Hospital
-
-
Hunan
-
Changsha, Hunan, China, 410013
- Recruiting
- Hunan Cancer hospital
-
Principal Investigator:
- Shanzhi Gu, Doctor
-
-
Jiangsu
-
Nanjing, Jiangsu, China, 210002
- Not yet recruiting
- General Hospital of Eastern Theater Command
-
Principal Investigator:
- Shukui Qin, Doctor
-
-
Jiangxi
-
Gannan, Jiangxi, China, 341000
- Recruiting
- First Affiliated Hospital of Gannan Medical University
-
Principal Investigator:
- Jianming Ye, Doctor
-
-
Shandong
-
Jinan, Shandong, China, 250000
- Recruiting
- Jinan Central Hospital
-
Principal Investigator:
- Meili Sun, Doctor
-
Qingdao, Shandong, China, 266042
- Recruiting
- Qingdao Central Hospital
-
Principal Investigator:
- Xuezhen Ma, Doctor
-
-
Shanghai
-
Shanghai, Shanghai, China, 200032
- Recruiting
- Zhongshan Hospital Affiliated to Fudan University
-
Principal Investigator:
- Tianshu Liu, Doctor
-
Shanghai, Shanghai, China, 022553
- Active, not recruiting
- Huashan Hospital,Fudan University
-
-
Shanxi
-
Taiyuan, Shanxi, China, 030000
- Recruiting
- Shanxi Provincial Cancer Hospital
-
Principal Investigator:
- Mudan Yang, Doctor
-
-
Tianjin
-
Tianjin, Tianjin, China, 300201
- Recruiting
- The 2nd Hospital of Tianjin Medical University
-
Principal Investigator:
- Haitao Wang, Doctor
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310003
- Active, not recruiting
- The 1st Affiliated Hospital of Zhejiang Medical University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Phase I of combinational therapy part: Histologically proven metastatic or locally advanced solid tumors, for which no effective standard treatment exists or standard therapy has failed.
Phase II of combinational therapy part and monotherapy part: Histologically confirmed metastatic or locally advanced selected solid tumor types with 0-2 prior lines of systemic therapy.
For cohorts 1 or 4, patients with biliary tract carcinoma failed to one prior systemic treatment. Patients with previous adjuvant/neo-adjuvant therapy completed within 6 months can be enrolled.
For cohort 2, patients with clear-cell renal cell carcinoma (or predominantly clear-cell subtype with primary tumor resected) after failure of no more than first-line standard therapy; For cohorts 3 or 5, patients with hepatocellular carcinoma must have progressed on prior first- or second-line standard therapy; Child-Pugh Class A; BCLC stage B or C, and not suitable for surgical or local therapy.
- Subjects are 18 years old or older when signing the informed consent and gender is not limited.
- Life expectancy of at least 12 weeks.
- Eastern Cooperative Group (ECOG) performance status of 0 to 1.
- At least one measurable lesion according to RECIST version 1.1.
- Tumor tissue must be available for biomarker analysis prior to the first dose of treatment, If not available, subjects can consult the investigator for enrollment agreement.
- Adequate hematological, hepatic and renal function as defined in the protocol.
- Subjects with HBV infection: HBV DNA<500 IU/mL or < 2500 copy/mL, must receive anti-HBV therapy.
- Subjects with HCV-RNA(+) must receive antiviral therapy.
- Able and willing to provide signed informed consent form, and able to comply with all procedures.
Other protocol defined inclusion criteria could apply.
Exclusion Criteria:
- For cohorts 1 or 4: known ampullary cancer or mixed cancer (HCC-ICC).
- For cohorts 3 or 5: known hepatocholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and lamellar cell carcinoma; history of hepatic encephalopathy.
- For subjects in combinational therapy part: prior treatment with any anti-PD-1/PD-L1, or anti-CTLA-4 agents (specifically targeting T-cell co-stimulation or checkpoint pathways), or TGF-β inhibitors.
- For cohort 4: prior treatment with VEGFR directed therapies including famitinib.
- Factors to affect oral administration.
- Major surgery procedure within 28 days prior to the first dose of trial treatment (excluding prior diagnostic biopsy or PICC); anticancer treatment within 28 days before the first dose of trial treatment; subjects in combinational therapy part who have received systemic steroid therapy or any other form of immunosuppressive therapy within 14 days prior to the first dose of trial treatment should also be excluded.
- Moderate-to-severe ascites with clinical symptoms.
- Active or history of central nervous system metastases.
- Known genetic or acquired hemorrhage or thrombotic tendency.
- History of gastrointestinal hemorrhage within 6 months prior to the start of study treatment or clear tendency of gastrointestinal haemorrhage.
Other protocol defined exclusion criteria could apply.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: combinational therapy part
SHR-1701 + famitinib
|
Famitinib, po, qd
Intravenous (IV) on Day 1 of each cycle
|
Experimental: monotherapy part
famitinib
|
Famitinib, po, qd
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
RP2D
Time Frame: First cycle (21 days)
|
Recommended phase-2 dosage
|
First cycle (21 days)
|
Objective response rate (ORR)
Time Frame: up to approximately 3 years (anticipated)
|
Defined as complete or partial response per RECIST 1.1
|
up to approximately 3 years (anticipated)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinically Significant Toxicity
Time Frame: First cycle (21 days)
|
Number of subjects in Phase I of combinational therapy part who experienced clinically significant toxicity
|
First cycle (21 days)
|
AEs+SAEs
Time Frame: up to approximately 3 years (anticipated)
|
The incidence and severity of Adverse Events and Serious Adverse Events
|
up to approximately 3 years (anticipated)
|
DCR
Time Frame: up to approximately 3 years (anticipated)
|
Disease Control Rate per RECIST 1.1
|
up to approximately 3 years (anticipated)
|
DoR
Time Frame: up to approximately 3 years (anticipated)
|
Duration of Response per RECIST 1.1
|
up to approximately 3 years (anticipated)
|
PFS
Time Frame: up to approximately 3 years (anticipated)
|
Progression-Free-Survival
|
up to approximately 3 years (anticipated)
|
OS
Time Frame: up to approximately 3 years (anticipated)
|
OS is the time interval from the start of treatment to death from any cause or lost of follow-up
|
up to approximately 3 years (anticipated)
|
6-month OS rate
Time Frame: From the start of treatment to 6 months
|
6-month-overall survival rate
|
From the start of treatment to 6 months
|
12-month-OS rate
Time Frame: From the start of treatment to 12 months
|
12-month- overall survival rate
|
From the start of treatment to 12 months
|
Cmax of SHR-1701
Time Frame: up to approximately 3 years (anticipated)
|
Maximum Plasma Concentration of SHR-1701
|
up to approximately 3 years (anticipated)
|
C6h of Famitinib
Time Frame: up to approximately 6 months (anticipated)
|
Plasma Concentration of 6 hours after famitinb administration
|
up to approximately 6 months (anticipated)
|
Cmax,ss
Time Frame: up to approximately 3 years (anticipated)
|
up to approximately 3 years (anticipated)
|
|
AUC0-24h,ss
Time Frame: up to approximately 3 years (anticipated)]
|
up to approximately 3 years (anticipated)]
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SHR-1701-II-203
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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