ClinicalTrials.gg
RecruitingNCT05306132Updated Dec 23, 2025

Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of ASKC202 With or Without ASK120067

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. (part of Beijing Aosaikang Pharmaceutical Co., Ltd.) · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2022; still recruiting 4 years 3 months later.

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Phase
Phase 1
Study type
Interventional
Enrollment
150
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Advanced Solid Tumor
03

In context

Lead sponsor

Jiangsu Aosaikang Pharmaceutical Co., Ltd. is the lead sponsor of 14 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Willing and able to provide signed and dated ;
  2. Aged 18 years old or more, male or female;
  3. Part 1 (Monotherapy Dose-Escalation) and Part 3 (Monotherapy Expansion): the subjects with locally advanced or solid tumors for whom no standard therapy regimens are available currently or who are intolerable to standard therapy regimens; Part 3: the subjects with MET gene amplification or protein overexpression; Part 3 cohort 1: or cytologically confirmed unresectable locally advanced or metastatic NSCLC.

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 (based on the 1.1 criterion) (this article is only for the dose expansion phase); 7) 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 ≥1.5 ×109/L ≥90×109/L ≥90g/L kidney Serum creatinine or (CrCl). ≤ 1.5 × or

≥60 mL/min (estimated from the Cockcroft-Gault formula) liver Total ≤1.5 × ULN or ≤2 × ULN (for patients with liver cancer or liver metastases). (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).

(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 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 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

Exclusion Criteria:

  1. Have previously received or are receiving any treatment for c-Mets (including all monoclonal antibodies or small molecule drugs targeted at the target, except for crizotinib);
  2. Have received chemotherapy, hormone therapy, immunotherapy, or biological therapy such as antibody therapy within 4 weeks prior to the first dose, or traditional Chinese medicine with anti-tumor indications within 2 weeks, or small molecule targeted therapy with an interval of less than 5 half-lives; palliative radiotherapy within 7 days or extensive/therapeutic radiotherapy within 14 days prior to the first dose;
  3. Those who still need to continue to use systemic or systemic (≥ 10 mg of prednisone or its equivalent other corticosteroid) for 2 weeks prior to the first dose;
  4. Patients who have used strong inhibitors or strong inducers of within 2 weeks prior to the first administration, or who need to continue treatment with these drugs during the study period;
  5. Participation in clinical trials of other drugs within 4 weeks prior to the first administration (except for failed screening);
  6. Patients who underwent other major surgical procedures other than diagnosis or within 4 weeks prior to the first dose, or who were expected to undergo major surgeries during the study period;
  7. Prior to the first administration, there are unhealed toxic reactions of ≥ grade 2 ( 5.0 standard) associated with any previous treatment, any level of hair loss, and platinum drugs Except for grade 2 neuropathy caused;
  8. Patients with primary central nervous system tumors or central nervous system including meningeal metastases (except those who are asymptomatic and stable, do not require steroid use for at least 4 weeks before the first dose);
  9. Gastrointestinal disorders (e.g., Crohn's disease, ulcerative colitis, intestinal obstruction, short bowel syndrome) or other malabsorption conditions that have difficulty swallowing or affect drug absorption;
  10. There are any other serious or uncontrolled acute and chronic diseases, such as severe or uncontrollable liver or kidney disease (except liver and kidney cancer), uncontrollable hypertension (blood pressure > 150/95 mmHg after antihypertensive therapy), and Acute pancreatitis, uncontrollable hyperglycemia (fasting blood glucose >8.0 mmol/L after hypoglycemic therapy), severe or uncontrolled eye lesions, etc
  11. Previous history includes interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis requiring steroid therapy, or evidence of clinically active ILD
  12. Have previously received hematopoietic stem cell transplants or solid organ transplants, or plan to receive hematopoietic stem cell transplants or solid organ transplants during the current period of study;
  13. If not controlled, large pleural effusions, pericardial effusions, or ascites that need to be drained still need;
  14. There are serious or active infections that required intravenous antibiotics or hospitalization, such as (HBsAg-positive and peripheral HBV-DNA titer test≥1×10\^4 copies/mL or 2000 IU/mL), , , and syphilis
  15. Meets any of the following cardiac criteria:

    a Average prolongation of 3 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 's cardiac function grade; f Echocardiography (ECHO) shows a (LVEF) ≤ 50%;

  16. allergies, or a previous history of severe allergies, or known allergies to any of the components of the drug under study;
  17. Pregnant, Lactating women;
  18. Other primary have been diagnosed within the last 5 years, and the following conditions can be enrolled: non-melanoma skin cancer, superficial bladder cancer, cervical carcinoma in situ that has undergone surgery and has been cured;
  19. Alcohol abuse, substance abuse, and other conditions that may increase the risk of the study or may interfere with study execution and analysis of results, or that the investigator believes that there are other reasons for which they are not suitable for this clinical study.
Terms in these criteria, in plain language(29)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

CTCAE grade

The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.

1
Mild.
2
Moderate.
3
Severe.
4
Life-threatening.
5
Death due to the event.

“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    ASKC202

    Participants received ASKC2020 50mg\~600mg orally

    Drug: ASKC202

  • Experimental
    ASKC202 plus ASK120067

    Participants received ASKC202 150 mg or 200 mg qd orally plus ASK120067 80 mg bid orally

    Drug: ASKC202 · Drug: ASK120067

Interventions

  • Dosage Forms: Tablets; Administration: Oral administration

  • DrugASK120067

    Drug pages: ASK-120067 · Aflutinib

    Dosage Forms: Tablets; Administration: Oral administration

    Also known as: Limertinib

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. Pharmacokinetics:maximum Plasma Concentration [Cmax]

    Serum samples will be collected for Cmax analysis.

    Time frame: up to 21 days following first dose

  2. 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

  3. Pharmacokinetics:Area Under Curve (AUC)

    Serum samples will be collected for AUC analysis.

    Time frame: up to 21 days following first dose

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

07

Study locations

3 of 3 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Aug 2022 (actual). Primary completion is estimated for Dec 2026, 52 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 23, 2022
First posted
Mar 31, 2022
StartActual
Aug 8, 2022
Primary completionEst.
Dec 2026
CompletionEst.
Dec 2027
Last update
Dec 23, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 23, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05306132
Responsible party
Sponsor
First posted
Mar 31, 2022
Start date
Aug 8, 2022
Primary completion
Dec 2026 (estimated)
Completion
Dec 2027 (estimated)
Last update
Dec 23, 2025

Study contacts

Han Luwei
Contact
hanluwei@ask-pharm.com
+86 25 86090621
Zhou Caicun, MD
principal investigator · Shanghai East Hospital Affiliated to Tongji University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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