Status:
UNKNOWN
A Study of SYHA1807 in Subjects With Extensive-Stage Small Cell Lung Cancer
Lead Sponsor:
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Conditions:
Extensive-Stage Small Cell Lung Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2021
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT04404543
Start Date
June 1 2020
End Date
June 30 2021
Last Update
May 27 2020
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