Advanced Solid TumorsPhase 1NCT04890587
A Phase I Study of AL8326 in Advanced Solid Tumor
A Phase 1 study testing AL8326 tablets in people with Advanced Solid Tumors, run by Advenchen Laboratories Nanjing Ltd. at 2 sites in China.
Trial summary
1. Main purpose Objective to study the tolerance and safety of single and multiple administration of repeated 28-day cycles of AL8326 in patients with advanced solid tumor, observe the dose limiting toxicity (DLT) and maximum tolerated dose (MTD). 2. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- AL8326 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesChina
- Study dates
- 17 Aug 2017to Dec 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Absolute neutrophil count (ANC) ≥ 1.5 × 10 ^ 9 / L (1500 / mm ^ 3), platelet ≥ 75 × 10 ^ 9 / L or hemoglobin ≥ 9g / dl.
- Serum total bilirubin ≤ 2 times the upper limit .
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- Serum creatinine ≤ 1.5 times the upper limit of normal value or creatinine clearance rate ≥ 50ml / min.
- If there is no liver metastasis, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 2.5 times of the upper limit, or liver metastasis ≤ 5 times of the upper limit .
- Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) ≥ 50%.
- According to the judgment of the investigator, the laboratory examination results and clinical abnormalities that will not affect the safety of the subjects and the completion of the trial can be arranged into the group.
- 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.
Who cannot join
- 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：
- Patients with previous history of central nervous system metastasis or uncontrollable symptoms of brain metastasis, spinal cord compression and cancerous meningitis within 8 weeks after the first administration. For patients with CNS metastasis or spinal cord compression, if the clinical status is stable and does not need hormone therapy, and the interval between the treatment (including radiotherapy or surgery) before entering the group is more than 4 weeks, they can participate in this trial.
- Grade 2 or above hypertension that cannot be controlled by single drug.
- Acute myocardial infarction occurred within 6 months.
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- At present, there are arrhythmias (such as long QT syndrome, unmeasurable or ≥ 480ms of Bazett's corrected QTC).
- NYHA cardiac function grade III or IV.
- Evidence of severe or uncontrollable systemic disease (e.g., unstable or decompensated respiratory, heart, liver, or kidney disease), as judged by the investigators.
- Any unstable systemic disease (including active infection, angina pectoris, liver and kidney or metabolic disease, etc.).
- Other (primary) malignancies (except for completely cured cervical carcinoma in situ or basal cell carcinoma or squamous cell skin carcinoma) within five years.
- The presence of clinically detectable third space effusion (such as ascites or pleural effusion) requires immediate drainage. Or after treatment, the effusion is not well controlled and continues to increase.
- Previous history of definite neurological or mental disorders, such as epilepsy or dementia.
- The function level of each organ was as follows：
- The results of urine protein analysis showed that urine protein was ≥ + +, and 24-hour urine protein was more than 1.0 g.
- Coagulation dysfunction: Patients with bleeding tendency (such as active peptic ulcer) or undergoing thrombolytic or anticoagulant therapy; under the premise of prothrombin time international normalized ratio (INR) ≤ 1.5, it is allowed to use low-dose warfarin (1mg oral, once a day) or low-dose aspirin (less than 100mg daily) for preventive purposes.
- Patients with arteriovenous thrombosis events within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep venous thrombosis and pulmonary embolism.
- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410013
Yu Huayue, +86-731-88651900, hnszlyy_irb@163.com
- Recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000
Zhu Jingjuan, zhujj123456@126.com
About this study
Official title: A Dose Escalation Tolerance and Pharmacokinetics Study of AL8326 in Advanced Solid Tumor
- Main purpose Objective to study the tolerance and safety of single and multiple administration of repeated 28-day cycles of AL8326 in patients with advanced solid tumor, observe the dose limiting toxicity (DLT) and maximum tolerated dose (MTD).
- Secondary purpose 1) Preliminary analysis of the pharmacokinetic characteristics and efficacy of repeated 28-day cycles of AL8326 tablets in patients with advanced solid tumors; 2) According to the results of phase I tolerance test and pharmacokinetics, appropriate dosage and regimen were recommended for phase II clinical trial;
Read the detailed description
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.
- Part I To evaluate the dose limiting toxicity (DLT) and general safety during the first 28-day cycle of Al8326 therapy and to evaluate the MTD. It will include a evaluation of 3 subjects per cohort in a 3+3 design in.
- Part II Subject will receive a dose from Part 1 of this study for continuous 28-Day cycles of therapy.
- Part III This design adopts 3 + 3 dose de-escalation method for exploration. At the same time, the safety, tolerance and pharmacokinetics were observed.
- Conditions
- Advanced Solid Tumors
- Being tested
- AL8326 tablets
- Keywords
- Maximum tolerated dose, Dose limiting toxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AL8326 tabletsDrug
Also called AL8326
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: AL8326 tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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;
Measured: 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;
Measured: cycle1 (each cycle is 28-days)
Secondary outcomes (9)
Cmax
The pharmacokinetic characteristics of Al8326 tablets in patients with advanced solid tumor were analyzed;
Measured: cycle1 (each cycle is 28-days)
Tmax
The pharmacokinetic characteristics of Al8326 tablets in patients with advanced solid tumor were analyzed;
Measured: cycle1 (each cycle is 28-days)
AUC0-t
The pharmacokinetic characteristics of Al8326 tablets in patients with advanced solid tumor were analyzed;
Measured: cycle1 (each cycle is 28-days)
AUC0-∞
The pharmacokinetic characteristics of Al8326 tablets in patients with advanced solid tumor were analyzed;
Measured: cycle1 (each cycle is 28-days)
Vd
The pharmacokinetic characteristics of Al8326 tablets in patients with advanced solid tumor were analyzed;
Measured: cycle1 (each cycle is 28-days)
Ke
The pharmacokinetic characteristics of Al8326 tablets in patients with advanced solid tumor were analyzed;
Measured: cycle1 (each cycle is 28-days)
CL
The pharmacokinetic characteristics of Al8326 tablets in patients with advanced solid tumor were analyzed;
Measured: cycle1 (each cycle is 28-days)
t1/2
The pharmacokinetic characteristics of Al8326 tablets in patients with advanced solid tumor were analyzed;
Measured: 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.
Measured: Every 3 cycles(each cycle is 28-days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2021
- Study start17 Aug 2017
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Advenchen Laboratories Nanjing Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nong Yang, Principal investigator, Central organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04890587
- Sponsor's protocol ID
- AL8326-CN-001
- Status last verified
- May 2021
- First submitted
- 26 Apr 2021
- Last updated
- 18 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose Escalation Tolerance and Pharmacokinetics Study of AL8326 in Advanced Solid Tumor
- ClinicalTrials.gov ID
- NCT04890587
- Acronym / sponsor ID
- AL8326-CN-001
- Conditions
- Advanced Solid Tumors
- Keywords
- Maximum tolerated dose, Dose limiting toxicity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Advenchen Laboratories Nanjing Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Aug 2017 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 18 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Main purpose Objective to study the tolerance and safety of single and multiple administration of repeated 28-day cycles of AL8326 in patients with advanced solid tumor, observe the dose limiting toxicity (DLT) and maximum tolerated dose (MTD).
- Secondary purpose 1) Preliminary analysis of the pharmacokinetic characteristics and efficacy of repeated 28-day cycles of AL8326 tablets in patients with advanced solid tumors; 2) According to the results of phase I tolerance test and pharmacokinetics, appropriate dosage and regimen were recommended for phase II clinical trial;
Detailed description
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.
- Part I To evaluate the dose limiting toxicity (DLT) and general safety during the first 28-day cycle of Al8326 therapy and to evaluate the MTD. It will include a evaluation of 3 subjects per cohort in a 3+3 design in.
- Part II Subject will receive a dose from Part 1 of this study for continuous 28-Day cycles of therapy.
- Part III This design adopts 3 + 3 dose de-escalation method for exploration. At the same time, the safety, tolerance and pharmacokinetics were observed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AL8326 | Experimental | Drug: AL8326 tabletsPart 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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;
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AL8326 tabletsAlso: AL8326Tablet:10mg/tablet; administered orally once daily in part 1 and part 2, administered orally twice daily for continuous 28-Day cycles in part 3. | Drug | AL8326 |
Primary outcome
Dose limiting toxicity (DLT)
Time frame: cycle1 (each cycle is 28-days)
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;
Maximum tolerated dose (MTD)
Time frame: cycle1 (each cycle is 28-days)
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;
9 secondary outcomes
Cmax
Time frame: cycle1 (each cycle is 28-days)
Tmax
Time frame: cycle1 (each cycle is 28-days)
AUC0-t
Time frame: cycle1 (each cycle is 28-days)
AUC0-∞
Time frame: cycle1 (each cycle is 28-days)
Vd
Time frame: cycle1 (each cycle is 28-days)
Ke
Time frame: cycle1 (each cycle is 28-days)
CL
Time frame: cycle1 (each cycle is 28-days)
t1/2
Time frame: cycle1 (each cycle is 28-days)
Primary antitumor efficiency of AL8326
Time frame: Every 3 cycles(each cycle is 28-days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nong Yang principal investigator
Central organization
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AL8326 tablets in people with Advanced Solid Tumors, run by Advenchen Laboratories Nanjing Ltd. at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yingyin Li (+8657188683590, annel@advenchen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limiting toxicity (DLT) (time frame: cycle1 (each cycle is 28-days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2021.