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

• Status: Not yet recruiting
• Trial end date: 2021-06-30
• Target enrollment: 0
• Participant gender: All

Summary

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).

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

Details

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

Criteria

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.