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

NCT04404543 | Unknown Phase 1

• 1 other identifier: SYHA1807-CSP-001
• Study Type: interventional
• Target: 71
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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

• Number of Participants Withdrawn Due to Toxicities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 The data for number of participants withdrawn due to toxicities has been presented.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

• 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

• 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 Outcomes (6)

• Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC [0-infinity]) Following Single Dose Administration of SYHA1807

  Through study completion, an average of 2 year

• Maximum Observed Plasma Concentration (Cmax) Following Single and Repeat Dose Administration of SYHA1807

  Through study completion, an average of 2 year

• Time to Reach Cmax (Tmax) Following Single and Repeat Dose Administration of SYHA1807

  Through study completion, an average of 2 year

• Apparent Terminal Phase Elimination Rate Constant (λz) Following Single and Repeat Dose Administration of SYHA1807

  Through study completion, an average of 2 year

• Apparent Terminal Phase Half-life (T1/2) Following Single and Repeat Dose Administration of SYH1A1807

  Through study completion, an average of 2 year

Other Outcomes (1)

• Value of NSE(Neurospecific enolase)、Pro-GRP(pro-gastrin releasing peptide)、CT (calcitonin) With Change From Baseline

  Through study completion, an average of 2 year

Study Arms (2)

Escalation Cohort

EXPERIMENTAL

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

Dose Expansion Cohort

EXPERIMENTAL

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

Interventions

SYHA1807 DRUG

Escalation Cohort Administration: Orally

Escalation Cohort

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: lead

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Kun Lou

  Department of Medicine, CSPC Clinical Development Division

  STUDY CHAIR

Central Study Contacts

Kun Lou

CONTACT

031167808817; loukun@mail.ecspc.com

Xuefang Xia

CONTACT

031167808812; xiaxuefang@mail.ecspc.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2020
• First Posted: May 27, 2020
• Study Start: June 1, 2020
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: May 27, 2020

Record last verified: 2020-05