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

Advanced or Metastatic Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04427774
• Other study ID #: CIBI391A101
• Status: Terminated
• Phase: Phase 1
• Start date: June 29, 2020
• Est. completion date: April 27, 2021

Study information

• Verified date: July 2021
• Source: Innovent Biologics (Suzhou) Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: April 27, 2021
• Est. primary completion date: February 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced or Metastatic Solid Tumors
• Neoplasms

Intervention

Drug:
• Surufatinib plus Sintilimab
Surufatinib will be given orally. Sintilimab will be given intravenously

Locations

Country	Name	City	State
China	Jiangsu Province	Nanjing

Sponsors (1)

Lead Sponsor	Collaborator
Innovent Biologics (Suzhou) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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