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

NCT04427774 | Terminated Phase 1

• 1 other identifier: CIBI391A101
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

Surufatinib plus Sintilimab

EXPERIMENTAL

Drug: Surufatinib plus Sintilimab

Interventions

Surufatinib plus Sintilimab DRUG

Surufatinib will be given orally. Sintilimab will be given intravenously

Surufatinib plus Sintilimab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Advanced or metastatic and recurrent cancer where an appropriate treatment option is not available
• Have measurable disease based on RECIST 1.1
• Life expectancy \> 12 weeks
• Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1

You may not qualify if:

• 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;
• Prior receipt of Surufatinib
• 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)
• 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
• Any life-threatening bleeding event or grade 3 or 4 bleeding requiring blood transfusion, endoscopy, or surgery with 3 months prior to dosing.

Sponsors & Collaborators

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

Study Sites (1)

Jiangsu Province

Nanjing, China

Location

MeSH Terms

Interventions

surufatinib; sintilimab

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2020
• First Posted: June 11, 2020
• Study Start: June 29, 2020
• Primary Completion: February 8, 2021
• Study Completion: April 27, 2021
• Last Updated: July 20, 2021

Record last verified: 2021-07

Locations

CN (1)