A Phase 1 interventional study of ASKC202 and ASK120067 in Advanced Solid Tumor, sponsored by Jiangsu Aosaikang Pharmaceutical Co., Ltd.. Recruiting at 3 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-23.
Sponsored by Jiangsu Aosaikang Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment
This study is the first-in-human of ASKC202, which is an open-label, non-randomized, multicenter study with a dose escalation phase and a dose expansion phase.
Jiangsu Aosaikang Pharmaceutical Co., Ltd. is the lead sponsor of 13 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
4)Part 2:(Combination Therapy Dose-Escalation):a)histologically or cytologically confirmed unresectable locally advanced or metastatic NSCLC;b)Histologically confirmed EGFR sensitizing mutation (Ex19del or L858R).;c)Disease progression following treatment with a third-generation EGFR TKI, or treatment with a first-/second-generation EGFR-TKI with confirmed T790M-negative status upon progression; d)MET gene amplification or protein overexpression.
5) Part 4:(Combination Therapy Dose-Expansion):a)histologically or cytologically confirmed unresectable locally advanced or metastatic NSCLC;b)Histologically confirmed EGFR sensitizing mutation (Ex19del or L858R).;c)MET gene amplification or protein overexpression.
6) At least one measurable lesion (based on the RECIST 1.1 criterion) (this article is only for the dose expansion phase); 7) ECOG score 0\~1; 8) Expected survival time ≥ 3 months; 9) Major organ function is essentially normal (no transfusions, erythropoietin (EPO), granulocyte colony-stimulating factor (G-CSF), or other medically supportive care have been received in the 14 days prior to the administration of the study drug), and laboratory tests during the screening period meet the following criteria: system Laboratory test values haematology Absolute neutrophil count ≥1.5 ×109/L platelet ≥90×109/L haemoglobin ≥90g/L kidney Serum creatinine or Creatinine clearance (CrCl). ≤ 1.5 × ULN or
≥60 mL/min (estimated from the Cockcroft-Gault formula) liver Total bilirubin ≤1.5 × ULN or ≤2 × ULN (for patients with liver cancer or liver metastases). AST(SGOT) and ALT (SGPT). ≤2.5 × ULN or ≤5 × ULN (for patients with liver cancer or liver metastases). Coagulation (no anticoagulation was received in the 7 days prior to the administration of the study drug).
International normalized ratio (INR) or prothrombin time (PT). ≤1.5 × ULN Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN 10) Women of childbearing age must have a pregnancy test (serum or urine) within 7 days of enrolling and have a negative result, or meet one of the following criteria to prove that there is no risk of pregnancy: a Postmenopausal is defined as amenorrhea at least 12 months after age >50 years and discontinuation of all exogenous hormone replacement therapy; b Women younger than 50 years of age who are considered postmenopausal if they have been amenorrhea for 12 months or more after stopping all exogenous hormone therapy, and luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels are within the laboratory reference values for postmenopausal; c Previously undergone irreversible sterilization procedures, including hysterectomy, bilateral ovarian resection, or bilateral salping, with the exception of bilateral tubal ligation; 11) Women of childbearing age should use strict contraceptive contraception throughout trial 7 and within 3 months after the last dose of the test drug; male subjects should use strict contraception throughout the trial period and for 6 months after the last dose of the test drug and no sperm donation; 12) The patient understands the purpose and steps of the trial, voluntarily participates in the trial, and signs a written informed consent form; 13) Patients have good comprehension, are able to follow protocol requirements and can cooperate with investigators in this trial.
Exclusion Criteria:
Meets any of the following cardiac criteria:
a Average QTc interval prolongation of 3 ECG examinations at rest (QTcF: 450 ms> for men > 470 ms for women, corrected by Fredericcia's formula); b Presence of uncontrolled or symptomatic arrhythmias, familial arrhythmias, or congenital long QT syndromes; c Had undergone coronary angioplasty, stent implantation, and coronary artery bypass grafting within 6 months before admission; d Myocardial ischemia or myocardial infarction, unstable angina within 6 months before admission; e Judged to be class III-IV congestive heart failure according to the New York Heart Association's cardiac function grade; f Echocardiography (ECHO) shows a left ventricular ejection fraction (LVEF) ≤ 50%;
Participants received ASKC2020 50mg\~600mg orally
Drug: ASKC202
Participants received ASKC202 150 mg or 200 mg qd orally plus ASK120067 80 mg bid orally
Drug: ASKC202 · Drug: ASK120067
Dosage Forms: Tablets; Administration: Oral administration
Dosage Forms: Tablets; Administration: Oral administration
Also known as: Limertinib
The incidence and case number of DLT (Dose Limiting Toxicity) during observation period
DLT is short for Dose Limiting Toxicity,dose-limiting describes side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment.
Time frame: up to 21 days following first dose
Maximum Tolerated Dose (MTD)
The MTD was defined as the highest dose of ASKC202 not causing DLT in more than 33% of patients in the first treatment cycle.
Time frame: up to 21 days following first dose
Number of participants with adverse events and serious adverse events as assessed by CTCAE v5.0
An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A serious AE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. The term TEAE is defined as AEs starting or worsening after the first intake of the study drug. TEAEs include both Serious TEAEs and non-serious TEAEs. Number of Participants with TEAEs and serious TEAEs were reported.
Time frame: up to 30 days following last dose
Pharmacokinetics:maximum Plasma Concentration [Cmax]
Serum samples will be collected for Cmax analysis.
Time frame: up to 21 days following first dose
Pharmacokinetics:terminal elimination half life (T1/2)
Serum samples will be collected for T1/2 analysis.
Time frame: up to 21 days following first dose
Pharmacokinetics:Area Under Curve (AUC)
Serum samples will be collected for AUC analysis.
Time frame: up to 21 days following first dose
ORR
Objective response rate (ORR) is defined as the percentage of complete response (CR) or partial response (PR), as determined according to RECIST v1.1.
Time frame: through study completion, an average of 2 years
DCR
Disease control rate (DCR) is defined as the percentage of CR or PR or stable disease (SD) , as determined according to RECIST v1.1.
Time frame: through study completion, an average of 2 years
DepOR
Depth of response (DepOR) is defined as the maximum percentage change in tumor size compared with baseline.
Time frame: through study completion, an average of 2 years
PFS
Progression-free survival (PFS) is defined as the time from the date of first treatment to the first occurrence of disease progression or death from any cause (whichever comes first), as determined according to RECIST v1.1.
Time frame: through study completion, an average of 2 years
DOR
Duration of response (DOR) is defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever comes first), as determined according to RECIST v1.1.
Time frame: through study completion, an average of 2 years
OS
overall survival (OS) is defined as the time from the date of first treatment to death from any cause.
Time frame: through study completion, an average of 3 years
Plan to share: No
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Jiangsu Aosaikang Pharmaceutical Co., Ltd.