A Phase 1 interventional study of HSK40118 in NSCLC, sponsored by Haisco Pharmaceutical Group Co., Ltd.. Recruiting at 12 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-22.
Sponsored by Haisco Pharmaceutical Group Co., Ltd. · Phase 1, Interventional, and Treatment
This is a phase I, open-label, dose-escalation and expansion study to evaluate the safety, tolerability, PK and PD of HSK40118 when given orally in patients with active EGFR mutation locally advanced or metastatic non-small cell lung cancer (NSCLC).
The study will contain two phase: Phase Ia is dose escalation phase and Phase Ib is dose expansion phase.
Phase Ia will contain two part: Dose Escalation Part(Part A) and Extension Part(Part B). Part A based on the "3+3" design for dose escalation and safety evaluation requirements. Patient cohorts at selected doses may be extended to further investigate the tolerability, PK and PD of HSK40118. The number of patients to be enrolled will be up to 10 subjects in each Part B cohort. Approximately 30-70 subjects will be enrolled in Phase Ia.
Phase Ib no less than 130 subjects will be enrolled in each expansion cohort, cohort A will be enrolled 30-50 subjects, cohort B will be enrolled no less than 100 subjects.
6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.
This study's planned enrollment of 220 is above the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Haisco Pharmaceutical Group Co., Ltd. is the lead sponsor of 114 studies on the registry; 48 are open to participants now.
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Patients in Phase Ia and Ib will fulfill the different criteria of the following:
Phase Ia(Part A): Previous treatment with at least one EGFR-TKI, including 1st, 2nd and 3rd-generation EGFR-TKI; Phase Ia(Part B)/Phase Ib: Previous treatment with 3rd-generation EGFR-TKI.
Exclusion Criteria:
Treatment with any of the following:
Prior treatment with an EGFR-TKI or other small-molecule anti-tumor drug within 7 days or approximately 5 × t1/2 prior to the first dose of HSK40118, whichever is shorter; Prior treatment with chemotherapy, palliative radiotherapy, or Herbal therapy within 2 weeks or approximately 5 × t1/2 prior to the first dose of HSK40118, whichever is shorter; Prior treatment with radiotherapy, immunotherapy/biotherapy therapy, or other pharmaceutical clinical trial within 4 weeks or approximately 5 × t1/2 prior to the first dose of HSK40118, whichever is shorter.
Phase 1a(Part A): dose escalation of HSK40118 as monotherapy at various dose levels
Drug: HSK40118
Phase 1a(Part B): dose extention of HSK40118 as monotherapy at certain dose levels
Drug: HSK40118
Phase 1b: dose expansion for HSK40118 as monotherapy at a dose determined during Phase 1 in patients with previous treatment with 3rd-generation EGFR-TKI
Drug: HSK40118
Oral administration, QD
MTD
MTD determination: dose limiting toxicity (DLT) rate
Time frame: Up to approximately 52 months
DLTs
Incidence of dose-limiting toxicities (DLTs) at Cycle 0 and Cycle1
Time frame: Up to approximately 52 months
AEs
Rate and severity of adverse events of HSK40118 as monotherapy
Time frame: Up to approximately 52 months
Eastern Cooperative Oncology Group Performance Status Scale(ECOG PS)
Change of the grade as a part of HSK40118 safety data. The functional status of patients will be assessed by the ECOG PS, which is described as a scale including grade 0(fully active) to grade 5(dead).
Time frame: Up to approximately 52 months
Overall response rate(ORR)
ORR, defined as the proportion of patients who experience a best response of confirmed CR or PR according to RECIST 1.1
Time frame: Up to approximately 52 months
Disease control rate (DCR)
DCR, defined as the proportion of patients who experience a best response of CR, PR, or stable disease (SD) according to RECIST 1.1
Time frame: Up to approximately 52 months
Duration of response (DOR)
DOR, defined as the time from first documented response of complete response (CR) or partial response (PR) to the date of first documented progressive disease or death due to any cause, whichever occurs first
Time frame: Up to approximately 52 months
Progression free survival (PFS)
PFS, defined as the time from the first dose of HSK40118 until the date of first documented progressive disease or death due to any cause, whichever occurs first
Time frame: Up to approximately 52 months
Overall survival (OS)
OS, defined as the time from the first dose of HSK40118 until the date of death due to any cause
Time frame: Up to approximately 52 months
AUC of HSK40118
Pharmacokinetics (PK) parameter of HSK40118. AUC is the definite integral of a curve that describes the variation of a drug concentration in blood plasma as a function of time. AUC reflects the actual body exposure to drug after single dosing and at steady state after multiple dosing.
Time frame: Blood samples will be collected on 6 occasions for each patient throughout study: cycle 0 day 1, cycle 0 day 2, cycle 0 day 3, cycle 1 day 1, cycle 1 day 8 and cycle 1 day 15.
Cmax of HSK40118
Pharmacokinetics (PK) parameter of HSK40118. Cmax is the maximum (or peak) serum concentration that the drug achieves in blood after the drug has been administered.
Time frame: Blood samples will be collected on 6 occasions for each patient throughout study: cycle 0 day 1, cycle 0 day 2, cycle 0 day 3, cycle 1 day 1, cycle 1 day 8 and cycle 1 day 15.
Cmin of HSK40118
Pharmacokinetics (PK) parameter of HSK40118. Cmin is the minimum (or trough) serum concentration that the drug achieves in blood at steady state after multiple dosing.
Time frame: Blood samples will be collected on 3 occasions for each patient throughout study: cycle 1 day 1, cycle 1 day 8 and cycle 1 day 15.
Tmax of HSK40118
Pharmacokinetics (PK) parameter of HSK40118. Tmax is defined as the time of maximum concentration of the drug in blood observed after single dosing and at steady state after multiple dosing.
Time frame: Blood samples will be collected on 6 occasions for each patient throughout study: cycle 0 day 1, cycle 0 day 2, cycle 0 day 3, cycle 1 day 1, cycle 1 day 8 and cycle 1 day 15.
Terminal half life(t1/2) after single dosing of HSK40118
Pharmacokinetics (PK) parameter of HSK40118 by assessment of the terminal half-life after single dosing.
Time frame: Blood samples will be collected on 3 occasions for each patient throughout study: cycle 0 day 1, cycle 0 day 2, cycle 0 day 3.
CL/F of HSK40118
Rate and extent of absorption of HSK40118 by assessment of apparent clearance following oral administration.
Time frame: Blood samples will be collected on 3 occasions for each patient throughout study: cycle 0 day 1, cycle 0 day 2, cycle 0 day 3.
Vd/F of HSK40118
Rate and extent of absorption of HSK40118 by assessment of the apprarent volume of distribution.
Time frame: Blood samples will be collected on 3 occasions for each patient throughout study: cycle 0 day 1, cycle 0 day 2, cycle 0 day 3.
λz of HSK40118
Pharmacokinetics (PK) parameter of HSK40118 by assessment of first-order rate constant associated with the terminal (log-linear) portion of the curve.
Time frame: Blood samples will be collected on 3 occasions for each patient throughout study: cycle 0 day 1, cycle 0 day 2, cycle 0 day 3.
MRT(Mean residence time) of HSK40118
Pharmacokinetics (PK) parameter of HSK40118 by assessment of mean residence time, which meas AUMC(Area under the moment curve)/AUC(Area under the curve) of drug concentration in blood plasma.
Time frame: Blood samples will be collected on 3 occasions for each patient throughout study: cycle 0 day 1, cycle 0 day 2, cycle 0 day 3.
Cav,ss(average concentration at steady state) of HSK40118
Pharmacokinetics (PK) parameter of HSK40118 by assessment of average concentration at steady state after multiple dosing.
Time frame: Blood samples will be collected on 3 occasions for each patient throughout study: cycle 1 day 1, cycle 1 day 8 and cycle 1 day 15.
EGFR protein degradation
Pharmacodynamics (PD) parameter of HSK40118 by assessment of the percentage of EGFR protein degradation at steady state after multiple dosing.
Time frame: Tissue samples will be collected on 2 occasions for each patient throughout study: screening period, cycle 1 day 15(±7 days).
circulation tumor DNA(ctDNA)
Pharmacodynamics (PD) parameter of HSK40118 by assessment of the concentration of ctDNA after multiple dosing.
Time frame: Blood samples will be collected on 3 occasions for each patient throughout study: screening period, cycle 2 day 1, cycle 3 day 1.
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Haisco Pharmaceutical Group Co., Ltd.