Clinical trial NCT04404543: A Study of SYHA1807 in Subjects With Extensive-Stage Small Cell Lung Cancer
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Extensive-Stage Small Cell Lung Cancer
Lead sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-05-27
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Part 1:Number of Participants With Adverse Events
timeFrame: Through study completion, an average of 2 year
measure: Part 1:Number of Participants With Serious Adverse Events (SAEs)
timeFrame: Through study completion, an average of 2 year
measure: Part 1:Number of Participants With Dose Limiting Toxicities (DLT)
timeFrame: Through study completion, an average of 2 year
measure: Number of Participants With Dose Reduction or Delays
timeFrame: Through study completion, an average of 2 year
measure: Number of Participants Withdrawn Due to Toxicities
timeFrame: Through study completion, an average of 2 year
measure: Number of Participants With Change in Clinical Chemistry Toxicity Grade From Baseline
timeFrame: Through study completion, an average of 2 year
measure: Number of Participants With Critical Changes in Values of Vital Signs in Response to Drug
timeFrame: Through study completion, an average of 2 year
Secondary outcomes:
measure: Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC [0-infinity]) Following Single Dose Administration of SYHA1807
timeFrame: Through study completion, an average of 2 year
measure: Maximum Observed Plasma Concentration (Cmax) Following Single and Repeat Dose Administration of SYHA1807
timeFrame: Through study completion, an average of 2 year
measure: Time to Reach Cmax (Tmax) Following Single and Repeat Dose Administration of SYHA1807
timeFrame: Through study completion, an average of 2 year
measure: Apparent Terminal Phase Elimination Rate Constant (λz) Following Single and Repeat Dose Administration of SYHA1807
timeFrame: Through study completion, an average of 2 year
measure: Apparent Terminal Phase Half-life (T1/2) Following Single and Repeat Dose Administration of SYH1A1807
timeFrame: Through study completion, an average of 2 year
measure: Number of Participants Achieving Disease Control Rate at Week 6、12
timeFrame: Through study completion, an average of 2 year
Other outcomes:
measure: Value of NSE(Neurospecific enolase)、Pro-GRP(pro-gastrin releasing peptide)、CT (calcitonin) With Change From Baseline
timeFrame: Through study completion, an average of 2 year
Locations:
Study officials:
affiliation: Department of Medicine, CSPC Clinical Development Division
name: Kun Lou
role: STUDY_CHAIR
References: