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

May 22, 2020 updated by: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

71

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
Drug: SYHA1807
Escalation Cohort Administration: Orally
Drug: SYHA1807
Dose Expansion Cohort Administration: Orally
Experimental: 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.
Drug: SYHA1807
Escalation Cohort Administration: Orally
Drug: SYHA1807
Dose Expansion Cohort Administration: Orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part 1:Number of Participants With Adverse Events
Time Frame: Through study completion, an average of 2 year
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
Part 1:Number of Participants With Serious Adverse Events (SAEs)
Time Frame: Through study completion, an average of 2 year
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
Part 1:Number of Participants With Dose Limiting Toxicities (DLT)
Time Frame: Through study completion, an average of 2 year
An event was considered a DLT if it occurs within the first 28 days of treatment.
Through study completion, an average of 2 year
Number of Participants With Dose Reduction or Delays
Time Frame: Through study completion, an average of 2 year
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
Number of Participants Withdrawn Due to Toxicities
Time Frame: Through study completion, an average of 2 year
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
Number of Participants With Change in Clinical Chemistry Toxicity Grade From Baseline
Time Frame: Through study completion, an average of 2 year
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
Number of Participants With Critical Changes in Values of Vital Signs in Response to Drug
Time Frame: Through study completion, an average of 2 year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC [0-infinity]) Following Single Dose Administration of SYHA1807
Time Frame: Through study completion, an average of 2 year
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
Maximum Observed Plasma Concentration (Cmax) Following Single and Repeat Dose Administration of SYHA1807
Time Frame: Through study completion, an average of 2 year
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
Time to Reach Cmax (Tmax) Following Single and Repeat Dose Administration of SYHA1807
Time Frame: Through study completion, an average of 2 year
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
Apparent Terminal Phase Elimination Rate Constant (λz) Following Single and Repeat Dose Administration of SYHA1807
Time Frame: Through study completion, an average of 2 year
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
Apparent Terminal Phase Half-life (T1/2) Following Single and Repeat Dose Administration of SYH1A1807
Time Frame: Through study completion, an average of 2 year
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
Number of Participants Achieving Disease Control Rate at Week 6、12
Time Frame: Through study completion, an average of 2 year
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Value of NSE(Neurospecific enolase)、Pro-GRP(pro-gastrin releasing peptide)、CT (calcitonin) With Change From Baseline
Time Frame: Through study completion, an average of 2 year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Investigators

  • Study Chair: Kun Lou, Department of Medicine, CSPC Clinical Development Division

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2020

Primary Completion (Anticipated)

June 30, 2021

Study Completion (Anticipated)

June 30, 2021

Study Registration Dates

First Submitted

May 14, 2020

First Submitted That Met QC Criteria

May 22, 2020

First Posted (Actual)

May 27, 2020

Study Record Updates

Last Update Posted (Actual)

May 27, 2020

Last Update Submitted That Met QC Criteria

May 22, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYHA1807-CSP-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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