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

NCT ID: NCT04427774

Last Updated: 2021-07-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-29
• Study Completion Date: 2021-04-27

Brief Summary

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

Conditions

Advanced or Metastatic Solid Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Surufatinib plus Sintilimab

Group Type: EXPERIMENTAL

Surufatinib plus Sintilimab

Intervention Type: DRUG

Surufatinib will be given orally. Sintilimab will be given intravenously

Interventions

Surufatinib plus Sintilimab

Surufatinib will be given orally. Sintilimab will be given intravenously

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Innovent Biologics (Suzhou) Co. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Jiangsu Province

Nanjing, , China

Countries

China

Other Identifiers

CIBI391A101

Identifier Type: -

Identifier Source: org_study_id