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

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

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

Study Overview

• Status: Terminated
• Conditions: Advanced or Metastatic Solid Tumors
• Intervention / Treatment: Drug: Surufatinib plus Sintilimab

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Nanjing, China
    • Jiangsu Province

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Surufatinib plus Sintilimab	Drug: Surufatinib plus Sintilimab; Surufatinib will be given orally. Sintilimab will be given intravenously

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2020
• Primary Completion (Actual): February 8, 2021
• Study Completion (Actual): April 27, 2021

Study Registration Dates

• First Submitted: June 9, 2020
• First Submitted That Met QC Criteria: June 9, 2020
• First Posted (Actual): June 11, 2020

Study Record Updates

• Last Update Posted (Actual): July 20, 2021
• Last Update Submitted That Met QC Criteria: July 19, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: CIBI391A101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No