A Phase I Trial of Simmitinib in Advanced Solid Tumors

• Status: Not yet recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open label, multi-center, phase I study of oral Simmitinib in subjects with advanced solid tumors including gastric cancer.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
• Collaborator: Shanghai Runshi Pharmaceutical Technology Co., Ltd

Criteria

Inclusion Criteria:

• Voluntary written informed consent of the patient obtained before any study-specific procedure；

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1;

• Patients with histologically/cytologically confirmed diagnosis of advanced solid tumors refractory to standard therapy or for whom no standard therapy exist;

• Adequate washing period from last anti-tumor therapy;

• Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1;

• The expected survival time for more than 12 weeks;

• Adequate bone marrow, hepatic, renal, pancreas, and coagulation function, Blood phosphorus and calcium in the normal range.

Exclusion Criteria:

• Prior treatment with selective FGFR inhibitors or multi-target kinase Inhibitors with FGFR as the main target;

• Unrecovered from any drug-related adverse event to grade ≤ 1 according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v.3.0 derived from any previous anti-tumor treatment, excluding alopecia, Pigmentation, or other toxicity with little safety risk for subjects;

• Active Central Nervous System (CNS) metastases (brain or leptomeningeal metastases, etc.);

• Any other history of malignancy within 3 years;

• Congenital coagulation abnormalities. Active bleeding or previous history of massive bleeding (>30ml within 3 months), history of hemoptysis (more than 5ml fresh bleeding within 4 weeks);

• Corneal diseases of clinical significance. There is a history of retinal pigment epithelial detachment or evidence of the presence of retinal pigment epithelial detachment. History of age-related macular degeneration or evidence of age-related macular degeneration exists；

• Subjects with impaired cardiac function or heart disease of clinical significance;

• Pregnant or lactating women.