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

Extensive-Stage Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04404543
• Other study ID #: SYHA1807-CSP-001
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: June 1, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: May 2020
• Source: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
• Contact: Kun Lou
• Phone: 031167808817
• Email: loukun[@]mail.ecspc.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 71
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Extensive-Stage Small Cell Lung Cancer
• Lung Neoplasms
• Small Cell Lung Carcinoma

Intervention

Drug:
• SYHA1807
Escalation Cohort Administration: Orally
• SYHA1807
Dose Expansion Cohort Administration: Orally

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Value of NSE(Neurospecific enolase)?Pro-GRP(pro-gastrin releasing peptide)?CT (calcitonin) With Change From Baseline	Analysis of the relationship between NSE(Neurospecific enolase)?Pro-GRP(pro-gastrin releasing peptide)?CT (calcitonin) NSE and anti-tumor activity.	Through study completion, an average of 2 year
Primary	Part 1:Number of Participants With Adverse Events	An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.	Through study completion, an average of 2 year
Primary	Part 1:Number of Participants With Serious Adverse Events (SAEs)	SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/birth defect, other situations and is associated with liver injury or impaired liver function.	Through study completion, an average of 2 year
Primary	Part 1:Number of Participants With Dose Limiting Toxicities (DLT)	An event was considered a DLT if it occurs within the first 28 days of treatment.	Through study completion, an average of 2 year
Primary	Number of Participants With Dose Reduction or Delays	The number of participants who had any dose reduction or delay have been presented. All dose reductions were due to AEs.	Through study completion, an average of 2 year
Primary	Number of Participants Withdrawn Due to Toxicities	Participants were monitored from start of the study till the development of toxicity. The data for number of participants withdrawn due to toxicities has been presented.	Through study completion, an average of 2 year
Primary	Number of Participants With Change in Clinical Chemistry Toxicity Grade From Baseline	Baseline value was defined as the most recent, non-missing value from a central laboratory prior to or on the first dose of study treatment. Change from Baseline was defined as any visit value minus Baseline value. The number of participants with any grade increase in hematology parameters have been presented.	Through study completion, an average of 2 year
Primary	Number of Participants With Critical Changes in Values of Vital Signs in Response to Drug	Vital sign measurements includes systolic blood pressure (SBP), diastolic blood pressure (DBP), temperature, respiration rate and heart rate. The number of participants with critical changes in values of vital signs in response to drug have been presented.	Through study completion, an average of 2 year
Secondary	Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC [0-infinity]) Following Single Dose Administration of SYHA1807	The analysis was performed on Pharmacokinetic Population which included all participants in the All Treated Population for whom a pharmacokinetic sample was obtained and analyzed.	Through study completion, an average of 2 year
Secondary	Maximum Observed Plasma Concentration (Cmax) Following Single and Repeat Dose Administration of SYHA1807	The analysis was performed on Pharmacokinetic Population which included all participants in the All Treated Population for whom a pharmacokinetic sample was obtained and analyzed.	Through study completion, an average of 2 year
Secondary	Time to Reach Cmax (Tmax) Following Single and Repeat Dose Administration of SYHA1807	The analysis was performed on Pharmacokinetic Population which included all participants in the All Treated Population for whom a pharmacokinetic sample was obtained and analyzed. Tmax is the time to reach Cmax, determined directly from the concentration-time data.	Through study completion, an average of 2 year
Secondary	Apparent Terminal Phase Elimination Rate Constant (?z) Following Single and Repeat Dose Administration of SYHA1807	The analysis was performed on Pharmacokinetic Population which included all participants in the All Treated Population for whom a pharmacokinetic sample was obtained and analyzed.	Through study completion, an average of 2 year
Secondary	Apparent Terminal Phase Half-life (T1/2) Following Single and Repeat Dose Administration of SYH1A1807	The analysis was performed on Pharmacokinetic Population which included all participants in the All Treated Population for whom a pharmacokinetic sample was obtained and analyzed.	Through study completion, an average of 2 year
Secondary	Number of Participants Achieving Disease Control Rate at Week 6?12	Clinical response was assessed by the investigator using computer tomography or magnetic resonance imaging scans. Clinical response was defined as disease control rate ,CR(Complete response)+PR(Partial response)+SD(Stable disease),based on RECIST version 1.1 at Week 6?12.	Through study completion, an average of 2 year