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

Phase 1

Terminated

• Conditions: Advanced or Metastatic Solid Tumors
• Interventions: Drug: Surufatinib plus Sintilimab

• Registration Number: NCT04427774
• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-09
• Study First Submitted QC: 2020-06-09
• Study First Posted: 2020-06-11
• Study Start: 2020-06-29
• Primary Completion: 2021-02-08
• Study Completion: 2021-04-27
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-19
• Last Update Posted: 2021-07-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Surufatinib plus Sintilimab	Surufatinib plus Sintilimab	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Jiangsu Province; 🇨🇳 Nanjing, China