Advanced or Metastatic Solid Tumors
Conditions
Brief summary
The purpose of this study is to evaluate the safety and efficacy of Surufatinib plus Sintilimab in Patients with Advanced Solid Tumor
Interventions
DRUGSurufatinib plus Sintilimab
Surufatinib will be given orally. Sintilimab will be given intravenously
Sponsors
Innovent Biologics (Suzhou) Co. Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Advanced or metastatic and recurrent cancer where an appropriate treatment option is not available 2. Have measurable disease based on RECIST 1.1 3. Life expectancy \> 12 weeks 4. Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1
Exclusion criteria
1. 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; 2. Prior receipt of Surufatinib 3. 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) 4. 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 5. Any life-threatening bleeding event or grade 3 or 4 bleeding requiring blood transfusion, endoscopy, or surgery with 3 months prior to dosing.
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
China
Outcome results
None listed