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

CSPC Pharmaceutical Group

Status and phase: Unknown; Phase 1

Conditions: Extensive-Stage Small Cell Lung Cancer

Treatments: Drug: SYHA1807

Study type: Interventional

Funder types: Industry

Identifiers

NCT04404543

SYHA1807-CSP-001

Details and patient eligibility

About

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).

Enrollment: 71 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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71 participants in 2 patient groups

Escalation Cohort

Experimental group

Description:

Five dose levels will be tested according to the "3 + 3" dose-escalation design. The dose-limiting toxicity (DLT) will be assessed from the first administration of SYHA1807 to the end of the first cycle (28 days).

Treatment:

Drug: SYHA1807

Drug: SYHA1807

Dose Expansion Cohort

Experimental group

Description:

Once the RP2D has been determined, an expansion cohort of up to 12\~40 subjects will be enrolled in order to better characterize the clinical activity and safety profile of the RP2D.

Treatment:

Drug: SYHA1807

Drug: SYHA1807