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| Name | Class |
|---|---|
| Jiangsu Aosaikang Biopharmaceutical Co., Ltd | UNKNOWN |
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This is an open label Phase 1/2 study, the purpose of the trial is to assess the safety, tolerability, pharmacokinetics, and antitumor activity of ASKB589 in patients suffering from advanced or metastatic solid tumors. Patients with gastric cancer/gastroesophageal junction adenocarcinoma and pancreatic cancer are preferred.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASKB589 Injection | Experimental | Experimental: ASKB589 Injection ASKB589 Injection treatment. This phase 1/II trial will include two stages, a dose escalation stage and an expansion stage. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASKB589 Injection | Drug | ASKB589 Injection with dose escalation stage of 0.3mg/kg up to 20mg/kg,as well as dose expansion stage with recommended dose level from dose escalation stage. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with serious adverse events (SAE) as assessed by CTCAE v5.0 | An SAE is defined as any untoward medical occurrence that, at any dose: a.) Results in death; b.) Is life-threatening; c.) Requires inpatient hospitalization or prolongation of existing hospitalization; d.) Results in persistent or significant disability/incapacity; e.) Is a congenital anomaly/birth defect; f.) Other important medical events; The number of participants who experience an SAE will be presented. | up to 21 days following last dose |
| 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. | up to 21 or 28 days following first dose |
| Number of participants with adverse events as assessed by CTCAE v5.0 | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be presented. | up to 21 days following last dose |
| Maximum Tolerated Dose (MTD) | The MTD was defined as the highest dose of ASKB589 not causing DLT in more than 33% of patients in the first treatment cycle. | up to 21 or 28 days following first dose |
| The recommended dose | The recommended dose will be determined during the dose escalation and dose expansion stage of the study. | from date of treatment start until data cut-off, up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics:maximum Plasma Concentration [Cmax] | Serum samples will be collected for Cmax analysis. | Up to 21 days after injection |
| Pharmacokinetics:time to maximum observed plasma concentration (Tmax) |
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Inclusion Criteria:
(1)Haemoglobin≥9 g/dL;platelet count≥ 100 × 109/L;absolute neutrophil count≥ 1.5 × 109/L;
(2)Albumin≥ 3.0g/dL;total bilirubin ≤ 1.5 times the upper limit of normal (ULN);aspartate transaminase and alanine aminotransferase≤ 2.5 times ULN if no demonstrable liver metastases ( ≤5 times ULN in the presence of liver metastases);
(3)Creatinine clearance≥ 50ml/min;
(4)Prothrombin time, international normalized ratio, and activated partial thromboplastin time≤1.5×ULN (except for patients receiving anticoagulant therapy)
4.Life expectancy of at least 3 months;
5.Patients who are supposed to be enrolled into the monotherapy dose escalation study must meet all the following criteria:
6.Patients who are supposed to be enrolled into the monotherapy dose expansion study must meet all the following criteria:
7.Patients who are supposed to be enrolled into the dose escalation of ASKB589 combined with chemotherapy should meet all the following criteria:
8.Patients who are supposed to be enrolled into the dose expansion of ASKB589 combined with chemotherapy should meet all the following criteria:
Exclusion Criteria:
(1)Congestive heart failure (defined as New York Heart Association Class III or IV), myocardial infarction, unstable angina, coronary angioplasty, stenting, coronary artery bypass graft, cerebrovascular accident (CVA) or hypertensive crisis within 6 months before the first drug treatment;
(2)History of clinically significant ventricular arrhythmia (such as sustained ventricular tachycardia, ventricular fibrillation or torsade de pointes);
(3)Patients have an abnormality in the 12-lead electrocardiogram (ECG) including a Fridericia's corrected QT interval (QTcF) greater than 450 milliseconds (ms) (males) or greater than 470 ms (females).
(4)History or family history of congenital long QT syndrome;
(5)Cardiac arrhythmias requiring anti-arrhythmic drug therapy (patients suffering from atrial fibrillation >1 month before the first administration of drug can be selected according to the condition of patients);
(6)Left ventricular ejection fraction <50%;
15.Pregnant or lactating women; or women of childbearing age who have a positive blood pregnancy test during screening period; or women of childbearing age and their spouses who are unwilling to take effective contraceptive measures during the period of this clinical trial and within 6 months after the end of the clinical trial;
16.Patients who are not meet the inclusion criteria based on the judgment of investigator;
17.Patients included in dose-escalation and expansion study of combined chemotherapy should also exclude:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing cancer hospital | Beijing | Beijing Municipality | 100089 | China | ||
| Linyi cancer hospital |
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| Objective response rate |
Evaluation of objective response rate assessed by response evaluation criteria in solid tumors version 1.1(RECIST 1.1) |
| from date of treatment start until disease progression,date of death or withdrawal from study,whichever came first, up to 2 years |
Serum samples will be collected for Tmax analysis.
| Up to 21 days after injection |
| Pharmacokinetics:elimination rate constant(Kel) | Serum samples will be collected for Kel analysis. | Up to 21 days after injection |
| Pharmacokinetics:terminal elimination half life (T1/2) | Serum samples will be collected for T1/2 analysis. | Up to 21 days after injection |
| Pharmacokinetics:apparent volume of distribution (Vz/F) | Serum samples will be collected for Vz/F analysis. | Up to 21 days after injection |
| Pharmacokinetics:Area Under Curve (AUC) | Serum samples will be collected for AUC analysis. | Up to 21 days after injection |
| Pharmacokinetics: Mean ResidenceTime(MRT) | Serum samples will be collected for MRT analysis. | Up to 21 days after injection |
| Pharmacokinetics: plasma clearance rate (CL) | Serum samples will be collected for CL analysis. | Up to 21 days after injection |
| Pharmacokinetics: steady-state peak concentration (Css_max) | Serum samples will be collected for Css_max analysis. | Up to 21 days after injection |
| Pharmacokinetics: time to steady-state peak concentration (Tss_max) | Serum samples will be collected for Tss_max analysis. | Up to 21 days after injection |
| Pharmacokinetics: minimum value of steady plasma drug concentration(Css_min) | Serum samples will be collected for Css max analysis. | Up to 21 days after injection |
| Evaluation of immunogenicity | Incidence of anti-drug antibodies (ADA) | from date of treatment start until data cut-off, up to 2 years |
| Objective response rate(ORR) | Evaluation of objective response rate assessed by RECIST 1.1 | from date of treatment start until disease progression,date of death or withdrawal from study,whichever came first, up to 2 years |
| disease control rate(DCR) | Evaluation of Disease control rate assessed by RECIST 1.1 | from date of treatment start until disease progression,date of death or withdrawal from study,whichever came first, up to 2 years |
| Duration of Response(DOR) | Duration of response assessed by RECIST 1.1 | from date of treatment start until disease progression,date of death or withdrawal from study,whichever came first, up to 2 years |
| Progression free survival(PFS) | Progression of tumor will be measured by RECIST v1.1 | from date of treatment start until the date of disease progression or until death due to any causes, up to 2 years. |
| Overall survival(OS) | defined as the time from the date of treatment start until date of death due to any cause | from the date of treatment start until the documented date of death from any cause,up to 2 years. |
| Linyi |
| Shandong |
| 276000 |
| China |