A Study of SYHA1807 in Subjects With Extensive-Stage Small Cell Lung Cancer

A Phase I, Open-label, Dose Escalation Study to Investigate the Safety, Pharmacokinetics and Clinical Activity of SYHA1807 Given Orally in Subjects With Extensive-Stage Small Cell Lung Cancer

This is a phase I, open-label, multi-center, non-randomized, 2-part first time inhuman (FTIH) study for SYHA1807. Part 1 is a dose escalation phase to determine the recommended phase 2 dose (RP2D) for SYHA1807 based on the safety, tolerability and pharmacokinetics (PK) profiles observed after oral administration of SYHA1807. The dose escalation study will be performed according to the 3+3 design. Once RP2D is identified, an expansion cohort (Part 2) of up to 12~40 subjects will be enrolled to further evaluate the clinical activity and tolerability of SYHA1807 in subjects with extensive-stage Small Cell Lung Cancer (SCLC).

Inclusion Criteria:

• Histologically confirmed diagnosis of advanced SCLC;
• ECOG(Eastern Cooperative Oncology Group) performance status of 0 or 1;
• Measurable disease according to RECIST v1.1;
• Recovered from all toxicities associated with previous treatments;
• Life expectancy ≥ 3 months;
• Adequate organ function;
• Use of reliable contraceptive methods;
• Signed informed consent from the patient;

Exclusion Criteria:

• Patients with primary malignant tumor other than small cell lung cancer;
• Identified central nervous system metastasis (such as brain metastasis or meningeal metastasis);
• Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage;
• Inadequate washout period for previous anti-tumor therapy;
• Previous treatment with any LSD1(lysine specific demethylase 1) inhibitor;
• Unable to swallow oral medications;
• History of serious systemic diseases;
• History of serious autoimmune diseases；
• HIV positive;
• Pregnant or lactating women.