A Study of AL58805 in Patients With Advanced Tumors
ConditionAdvanced Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAdvenchen Laboratories Nanjing Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with histologically or cytologically confirmed advanced tumors (including but not limited to lymphoma, colorectal cancer, breast cancer, pancreatic cancer, lung cancer, head and neck cancer, bladder cancer, cholangiocarcinoma) who lack effective standard treatment options or have failed conventional standard treatments (due to disease progression or intolerable toxicity).
Previous treatment with cytotoxic chemotherapy, with at least 4 weeks between the end of chemotherapy and enrollment, and recovery from previous chemotherapy toxicities to ≤ Grade 1 (except alopecia).
Must have measurable lesions according to RECIST 1.1 criteria.
Major organ function: Absolute neutrophil count (ANC) ≥1.5 × 10^9/L (1500/mm3), platelets ≥75 × 10^9/L, hemoglobin ≥9g/dL. Serum total bilirubin ≤2 × upper limit of normal (ULN). Serum creatinine ≤1.5 × ULN or creatinine clearance ≥50 mL/min. For patients without liver metastases, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN; for patients with liver metastases, ALT and AST ≤5 × ULN. Left ventricular ejection fraction (LVEF) ≥ lower limit of normal.
Disqualifiers
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.
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.
Previous treatment with the investigational drug.
Trial design
Design model
Single group
Treatments tested in this trial
AL58805
DrugOral,Multiple administrations, once or twice daily（20mg 、40mg QD; 20mg 、30mg、40mg、50mg、60mg BID；）
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: AL58805Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.)
Time frame
From signing the ICF until 28 days after the first dosingSecondary outcomes
1
Tmax
Determine the time to reach maximum plasma concentration (Tmax) of AL58805 after single administration and continuous administration for 28 days.
Time frame
Conduct testing within 1 month after all subjects collect plasma samples at all time points required by the protocol.2
Css_min
Measure the minimum steady - state plasma concentration (Css\_min) of AL58805 during continuous administration for 28 days.
Time frame
Conduct testing within 1 month after all subjects collect plasma samples at all time points required by the protocol.3
Css_av
Calculate the average steady - state plasma concentration (Css\_av) of AL58805 during continuous administration for 28 days.
Time frame
Conduct testing within 1 month after all subjects collect plasma samples at all time points required by the protocol.4
T1/2
Estimate the elimination half - life (T1/2) of AL58805 after single administration and continuous administration for 28 days.
Time frame
Conduct testing within 1 month after all subjects collect plasma samples at all time points required by the protocol.Sponsors and contacts
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Source ClinicalTrials.gov