A Trial of SHR-1701 in Combination With Famitinib in Patients With Advanced Solid Tumors
NCT ID: NCT04679038
Last Updated: 2022-01-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
222 participants
INTERVENTIONAL
2021-03-17
2023-10-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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combinational therapy part
SHR-1701 + famitinib
SHR-1701
Intravenous (IV) on Day 1 of each cycle
Famitinib
Famitinib, po, qd
monotherapy part
famitinib
Famitinib
Famitinib, po, qd
Interventions
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SHR-1701
Intravenous (IV) on Day 1 of each cycle
Famitinib
Famitinib, po, qd
Eligibility Criteria
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Inclusion Criteria
2. 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.
3. Subjects are 18 years old or older when signing the informed consent and gender is not limited.
4. Life expectancy of at least 12 weeks.
5. Eastern Cooperative Group (ECOG) performance status of 0 to 1.
6. At least one measurable lesion according to RECIST version 1.1.
7. 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.
8. Adequate hematological, hepatic and renal function as defined in the protocol.
9. Subjects with HBV infection: HBV DNA\<500 IU/mL or \< 2500 copy/mL, must receive anti-HBV therapy.
10. Subjects with HCV-RNA(+) must receive antiviral therapy.
11. Able and willing to provide signed informed consent form, and able to comply with all procedures.
Exclusion Criteria
2. For cohorts 3 or 5: known hepatocholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and lamellar cell carcinoma; history of hepatic encephalopathy.
3. 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.
4. For cohort 4: prior treatment with VEGFR directed therapies including famitinib.
5. Factors to affect oral administration.
6. 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.
7. Moderate-to-severe ascites with clinical symptoms.
8. Active or history of central nervous system metastases.
9. Known genetic or acquired hemorrhage or thrombotic tendency.
10. History of gastrointestinal hemorrhage within 6 months prior to the start of study treatment or clear tendency of gastrointestinal haemorrhage.
18 Years
ALL
No
Sponsors
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Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Anhui Provincial Hospital
Hefei, Anhui, China
The 2nd Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Henan Cancer Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Hunan Cancer Hospital
Changsha, Hunan, China
General Hospital of Eastern Theater Command
Nanjing, Jiangsu, China
First Affiliated Hospital of Gannan Medical University
Gannan, Jiangxi, China
Jinan Central Hospital
Jinan, Shandong, China
Qingdao Central Hospital
Qingdao, Shandong, China
Huashan Hospital,Fudan University
Shanghai, Shanghai Municipality, China
Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, China
The 2nd Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, China
The 1st Affiliated Hospital of Zhejiang Medical University
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Other Identifiers
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SHR-1701-II-203
Identifier Type: -
Identifier Source: org_study_id
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