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

NCT ID: NCT04404543

Last Updated: 2020-05-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2021-06-30

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 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).

Conditions

Extensive-Stage Small Cell Lung Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Escalation Cohort

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).

Group Type: EXPERIMENTAL

SYHA1807

Intervention Type: DRUG

Escalation Cohort Administration: Orally

Dose Expansion Cohort

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.

Group Type: EXPERIMENTAL

SYHA1807

Intervention Type: DRUG

Dose Expansion Cohort Administration: Orally

Interventions

SYHA1807

Escalation Cohort Administration: Orally

Intervention Type: DRUG

SYHA1807

Dose Expansion Cohort Administration: Orally

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kun Lou

Role: STUDY_CHAIR

Department of Medicine, CSPC Clinical Development Division

Central Contacts

Kun Lou

Role: CONTACT

loukun@mail.ecspc.com

031167808817 ext. 031167808817

Xuefang Xia

Role: CONTACT

xiaxuefang@mail.ecspc.com

031167808812 ext. 031167808812

Other Identifiers

SYHA1807-CSP-001

Identifier Type: -

Identifier Source: org_study_id