Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This Phase I clinical trial is a dose-escalation, multicenter study in patients with advanced solid tumors. It includes tolerance studies of sequential multiple oral doses of AL58805 and pharmacokinetic studies of single and multiple doses, analyzing the tolerance range of multiple doses, observing the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) in solid tumor patients, and assessing the reversibility of toxicity and the relationship between toxicity and dose.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AL58805 | Experimental | 20mg 、40mg QD; 20mg 、30mg、40mg、50mg、60mg BID; |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AL58805 | Drug | Oral,Multiple administrations, once or twice daily(20mg 、40mg QD; 20mg 、30mg、40mg、50mg、60mg BID;) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicity | It is the evaluation of dose-limiting toxicity (DLT) and general safety that occur during the single administration and the first continuous administration treatment cycle. The evaluation depends on the criteria for DLT. The parameters used to assess safety in this study include adverse events, physical examinations, vital signs (especially blood pressure), and laboratory tests (including serum chemistry, hematology, urine routine, and electrocardiogram (ECG), etc.) | From signing the ICF until 28 days after the first dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax | Determine the time to reach maximum plasma concentration (Tmax) of AL58805 after single administration and continuous administration for 28 days. | Conduct testing within 1 month after all subjects collect plasma samples at all time points required by the protocol. |
| Css_min |
Not provided
Inclusion Criteria:
Subjects must meet all the following criteria to be eligible:
Ability to understand and sign informed consent.
Exclusion Criteria:
Subjects meeting any of the following criteria will be excluded:
Known allergy to the investigational drug or drugs with similar chemical structures.
Use of unapproved drugs or other investigational drugs within 30 days before enrollment.
Status of the organ systems:
Current symptomatic brain metastases or leptomeningeal metastases, or central nervous system (CNS) metastases with uncontrolled symptoms within 8 weeks of first dose.
Uncontrolled hypertension requiring multiple medications (Grade 2 or higher). Acute myocardial infarction within 6 months. Current arrhythmias (e.g., long QT syndrome, Bazett's corrected QTc ≥480 ms). NYHA Class III or IV heart failure. Poorly controlled diabetes. Any unstable systemic disease (including active infection, angina, hepatic, renal, or metabolic diseases).
Presence of ascites or pleural effusion (CTCAE 5.0 ≥ Grade 2). Persistent diarrhea (average watery stools ≥1 per day). History of definite neurological or psychiatric disorders (e.g., epilepsy, dementia, mood disorders).
The functional level of each organ: Urine protein ≥++ and 24-hour urine protein >1.0 g. Patients treated with anticoagulants or vitamin K antagonists, such as warfarin, heparin, or their analogs, should have an international normalized ratio (INR) of prothrombin time ≤1.5. In this case, low-dose warfarin (1mg, orally, once daily) or low-dose aspirin (daily dose not exceeding 100mg) can be used for prophylactic purposes. All other conditions are considered exclusion criteria.
Patients with active/venous thrombosis events within 6 months, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis and pulmonary embolism.
Previous treatment with the investigational drug.
Patients exhibiting hepatitis B surface antigen (HBsAg) positivity with HBV DNA concentrations ≥10⁴ copies/mL (equivalent to 2000 IU/mL) must initiate antiviral therapy prior to study consideration. Eligibility for enrollment is contingent upon achieving sustained HBV-DNA suppression below these threshold values. Antiviral therapy will be maintained throughout the study period with concurrent monitoring of hepatic function parameters and quantitative HBV DNA levels. The exclusion criteria further encompass individuals with detectable HCV antibodies or HCV RNA, HIV seropositivity, congenital/acquired immunodeficiencies, or prior organ transplantation history.
Concurrent other anti-tumor treatments. Other conditions deemed unsuitable by the investigator.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li Sha Qi | Contact | 025-52896159 | qilisha@advenchen.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Dongfang Li | Hunan Cancer Hospital | Principal Investigator |
| Yongchang Zhang | Hunan Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunan Cancer Hospital | Recruiting | Changsha | Hunan | 410013 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Measure the minimum steady - state plasma concentration (Css_min) of AL58805 during continuous administration for 28 days. |
| Conduct testing within 1 month after all subjects collect plasma samples at all time points required by the protocol. |
| Css_av | Calculate the average steady - state plasma concentration (Css_av) of AL58805 during continuous administration for 28 days. | Conduct testing within 1 month after all subjects collect plasma samples at all time points required by the protocol. |
| T1/2 | Estimate the elimination half - life (T1/2) of AL58805 after single administration and continuous administration for 28 days. | Conduct testing within 1 month after all subjects collect plasma samples at all time points required by the protocol. |
| CL or CL/F | Assess the clearance (CL) or apparent clearance (CL/F) of AL58805 after single administration and continuous administration for 28 days. | Conduct testing within 1 month after all subjects collect plasma samples at all time points required by the protocol. |
| AUCss | Evaluate the area under the steady - state plasma concentration - time curve (AUCss) of AL58805 during continuous administration for 28 days. | Conduct testing within 1 month after all subjects collect plasma samples at all time points required by the protocol. |
| DF | Calculate the fluctuation index (DF) of AL58805 during continuous administration for 28 days. | Conduct testing within 1 month after all subjects collect plasma samples at all time points required by the protocol. |