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Clinical Trials/NCT04427774
NCT04427774TerminatedPhase 1

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

Innovent Biologics (Suzhou) Co. Ltd.1 site in 1 country8 target enrollmentStarted: June 29, 2020Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Terminated
Enrollment
8
Locations
1
Primary Endpoint
Safety and tolerability assessed by monitoring frequency, duration, and severity of adverse events (AEs)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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.

Arms & Interventions

Surufatinib plus Sintilimab

Experimental

Intervention: Surufatinib plus Sintilimab (Drug)

Outcomes

Primary Outcomes

Safety and tolerability assessed by monitoring frequency, duration, and severity of adverse events (AEs)

Time Frame: Baseline through 30 days after end of treatment, up to approximately 24months

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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