A Study of Surufatinib Plus Sintilimab in Patients With Advanced Solid Tumor

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and efficacy of Surufatinib plus Sintilimab in Patients with Advanced Solid Tumor

Official Title
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A Phase Ib Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of Surufatinib Plus Sintilimab in Patients With Advanced Solid Tumor

Conditions
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Advanced or Metastatic Solid Tumors

Intervention / Treatment
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* Drug: Surufatinib plus Sintilimab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Advanced or metastatic and recurrent cancer where an appropriate treatment option is not available Have measurable disease based on RECIST 1.1 Life expectancy > 12 weeks Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1 Exclusion Criteria: Any therapy with anti-PD-1, or anti-PD-L1/l2 antibodies or anti-cytotoxic T lymphocyte associated antigen-4 (CTLA-4) antibody (or any other antibody acting on T cell costimulatory or checkpoint pathway) or fruquintinib treatment in previous; Prior receipt of Surufatinib History of any active autoimmune disease or autoimmune disease, including but not limited to interstitial pneumonia, uveitis, inflammatory bowel disease, hepatitis, pituitary inflammation, vasculitis, systemic lupus erythematosus, etc. (except patients with hypothyroidism that can be controlled only by hormone replacement therapy and patients with type I diabetes who only need insulin replacement therapy) History of gastrointestinal perforation and/or fistula, ileus, inflammatory bowel disease, or extensive enterotomy (partial colectomy or extensive enterotomy with chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea within 6 months prior to first dosing Any life-threatening bleeding event or grade 3 or 4 bleeding requiring blood transfusion, endoscopy, or surgery with 3 months prior to dosing.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Surufatinib plus Sintilimab<br> | Drug: Surufatinib plus Sintilimab<br>* Surufatinib will be given orally. Sintilimab will be given intravenously<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability assessed by monitoring frequency, duration, and severity of adverse events (AEs) |  | Baseline through 30 days after end of treatment, up to approximately 24months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate in subjects with measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 |  | Baseline and every 6 weeks through week 48, and then every 12 weeks |