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This is a Phase 1 study to evaluate the safetyand efficacy of 28-day cycles of AL8326 therapy. The study is divided into three parts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AL8326 | Experimental | Part 1:(closed)Cohort 1 will initiate with AL8326 for single dose and multiple dose (28-Day cycles) . After three subjects have completed the first cycle of therapy without a DLT, additional cohorts may be enrolled sequentially. After the first cohort has completed one full cycle of therapy without a DLT, several additional cohorts will be sequentially for the same 28-day cycles. Part 2 :(open)Each subject will receive a dose from Part 1 of this study for continuous 28-Day cycles of therapy. Part 3:(open)Cohort 3 will initiate with AL8326(bid), for 28-Day cycles . After three subjects have completed the first cycle of therapy without a DLT, additional cohorts may be enrolled sequentially. After the first cohort has completed one full cycle of therapy without a DLT, two additional cohorts will be sequentially enrolled at decreased dose of AL8326 for the same 28-day cycles. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AL8326 tablets | Drug | Tablet:10mg/tablet; administered orally once daily in part 1 and part 2, administered orally twice daily for continuous 28-Day cycles in part 3. |
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| Measure | Description | Time Frame |
|---|---|---|
| Dose limiting toxicity (DLT) | To observe the durability and safety of AL8326 in patients with advanced solid tumor after single and multiple administration, observe the dose limiting toxicity (DLT)and the reversibility of toxicity; | cycle1 (each cycle is 28-days) |
| Maximum tolerated dose (MTD) | To observe the durability and safety of AL8326 in patients with advanced solid tumor after single and multiple administration, observe the maximum tolerated dose (MTD),the relationship between toxicity and dose; | cycle1 (each cycle is 28-days) |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | The pharmacokinetic characteristics of Al8326 tablets in patients with advanced solid tumor were analyzed; | cycle1 (each cycle is 28-days) |
| Tmax | The pharmacokinetic characteristics of Al8326 tablets in patients with advanced solid tumor were analyzed; |
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Inclusion Criteria:
Patients with the following advanced solid tumors confirmed by histology or cytology (including but not limited to non-small cell lung cancer, cervical cancer, ovarian cancer, breast cancer, pancreatic cancer, liver cancer, colon cancer, head and neck cancer, prostate cancer, kidney cancer, etc.). Lack of effective standard treatment options; or failure (including disease progression or intolerance) or recurrence after conventional standard treatment.
For subject received cytotoxic drugs chemotherapy before, the interval between the end of chemotherapy and the signing of informed consent was at least 4 weeks, and must be recovered from the toxic reaction of previous chemotherapy to ≤ 1 grade (except for hair loss);
There must be at least measurable lesions in accordance with RECIST 1.1. If there is only one lesion, the lesion must be confirmed by cytology / histology.
Main organ function:
ECOG (PS) score was 0,1;
Life expectancy ≥ 12 weeks;
Age ≥ 18 years old and ≤ 70 years old;
There was no malabsorption or other gastrointestinal diseases affecting drug absorption.
Female: for female patients with fertility, pregnancy test must be conducted before treatment, and contraceptive method approved by medical department must be adopted during treatment and within 3 months after treatment; serum or urine pregnancy test in screening period must be negative; it must be non lactation period; and;if a female patient is postmenopausal but has not yet reached the postmenopausal state (the duration of menopause is greater than or equal to 12 consecutive months, and there is no other reason except menopause), and has not received sterilization surgery (removal of ovaries and / or uterus), she is considered to be fertile.
Male: during surgical sterilization or treatment and within 3 months after the end of the treatment, the contraceptive measures approved by the doctor were adopted;
Ability to understand and sign informed consent.
Exclusion Criteria:
It is known that it is allergic to drugs with similar chemical structure.
Use of drugs or other trial drugs without approval within 30 days before enrollment.
The condition of each organ system was as follows:
The function level of each organ was as follows:
The patients who had been enrolled before who had withdrawn from this study.
HIV antibody is positive, or the patient has other acquired or congenital immunodeficiency disease, or has a history of organ transplantation.
At the same time, they received any other anti-tumor treatment.
The researcher thinks that it is not suitable to participate in this study.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yingyin Li | Contact | +8657188683590 | annel@advenchen.com | |
| Huaqing He | Contact | +8615205140516 | huaqingh@advenchen.com |
| Name | Affiliation | Role |
|---|---|---|
| Nong Yang | Central organization | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunan Cancer Hospital | Recruiting | Changsha | Hunan | 410013 | China |
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| cycle1 (each cycle is 28-days) |
| AUC0-t | The pharmacokinetic characteristics of Al8326 tablets in patients with advanced solid tumor were analyzed; | cycle1 (each cycle is 28-days) |
| AUC0-∞ | The pharmacokinetic characteristics of Al8326 tablets in patients with advanced solid tumor were analyzed; | cycle1 (each cycle is 28-days) |
| Vd | The pharmacokinetic characteristics of Al8326 tablets in patients with advanced solid tumor were analyzed; | cycle1 (each cycle is 28-days) |
| Ke | The pharmacokinetic characteristics of Al8326 tablets in patients with advanced solid tumor were analyzed; | cycle1 (each cycle is 28-days) |
| CL | The pharmacokinetic characteristics of Al8326 tablets in patients with advanced solid tumor were analyzed; | cycle1 (each cycle is 28-days) |
| t1/2 | The pharmacokinetic characteristics of Al8326 tablets in patients with advanced solid tumor were analyzed; | cycle1 (each cycle is 28-days) |
| Primary antitumor efficiency of AL8326 | Patients with advanced solid tumors and their efficacy in patients with advanced solid tumors were evaluated according to RECIST 1.1. | Every 3 cycles(each cycle is 28-days) |
| The Affiliated Hospital of Qingdao University | Recruiting | Qingdao | Shandong | 266000 | China |
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