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

Innovent Biologics

Status and phase: Terminated; Phase 1

Conditions: Advanced or Metastatic Solid Tumors

Treatments: Drug: Surufatinib plus Sintilimab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04427774

CIBI391A101

Details and patient eligibility

About

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

Enrollment: 8 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Surufatinib plus Sintilimab

Experimental group

Treatment:

Drug: Surufatinib plus Sintilimab