Effect of High-fat Meal on the Pharmacokinetics of TQ-B3139 Capsules

Study Overview
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Brief Summary
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This is a study to evaluate the effect of high-fat meal on the pharmacokinetics of TQ-B3139 capsules in patients with solid tumor

Official Title
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A Study of the Effect of High-fat Meal on the Pharmacokinetics of Oral TQ-B3139 Capsules in Patients With Solid Tumor

Conditions
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Advanced Solid Tumors

Intervention / Treatment
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* Drug: TQ-B3139 capsules


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 to 1. 2. Life expectancy ≥12 weeks. 3. Patients with confirmed gene mutations, including ALK fusion, ROS1 fusion, MET mutation or amplification. 4. Adequate organ system function. 5.Female patients of childbearing age should agree to use contraceptive measures during the study period and for at least 6 months after study is stopped; male patients should agree to use contraception during the study period and for at least 6 months after study is stopped. 6.Understood and signed an informed consent form. Exclusion Criteria: 1. Has other malignancies within 3 years. 2. Has multiple factors affecting oral medication. 3. The toxicity of previous antitumor treatment is not recovered to ≤ grade 1(CTCAE 5.0) . 4. Has received major surgical treatment, open biopsy or obvious traumatic injury within 28 days before the first dose. 5. Has long-term unhealed wounds or fractures. 6. Has a history of psychotropic drug abuse or have a mental disorder. 7. Has any severe and/or uncontrolled disease. 8. Has received surgery, chemotherapy, radiotherapy or other anticancer therapies 4 weeks or 5 half-life of drug elimination (whichever comes first) before the first dose. 9. Has participated in other clinical studies within 4 weeks before enrollment. 10.Using inhibitors or inducers of CYP3A at present. 11. Has receiving Chinese patent medicines with anti-tumor indications in the drug instructions that NMPA approved within 2 weeks before the start of the study treatment. 12. Pleural effusion, pericardial effusion or ascites that cannot be controlled and need repeated drainage. 13. Brain metastases with symptoms or symptoms of brain metastases were controlled for less than 2 weeks. 14. In lactation period or plan to breastfeed during the study period. 15.According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>TQ-B3139 capsules administered single dose of 600 mg under fasted conditions in day 1 followed by single dose of 600 mg with a high-fat meal in day 5, then TQ-B3139 capsules administered 600mg orally, twice daily. | Drug: TQ-B3139 capsules<br>* TQ-B3139 capsules administered 600mg orally, twice daily in 28-day cycle.<br>|
| Experimental: Cohort 2<br>TQ-B3139 capsules administered single dose of 600 mg with a high-fat meal in day 1 followed by single dose of 600 mg under fasted conditions in day 5, then TQ-B3139 capsules administered 600mg orally, twice daily. | Drug: TQ-B3139 capsules<br>* TQ-B3139 capsules administered 600mg orally, twice daily in 28-day cycle.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC0-t | To characterize the pharmacokinetics of TQ-B3139 by assessment of area under the plasma concentration time curve from zero to time. | 0hour, 1hour, 2hour, 3hour, 4hour, 5hour, 6hour, 7hour, 8hour, 10hour, 24hour, 48hour,72hour, 96hour on day 1 and day 5. | 
| AUC0-∞ | To characterize the pharmacokinetics of TQ-B3139 by assessment of area under the plasma concentration time curve from zero to infinity. | 0hour, 1hour, 2hour, 3hour, 4hour, 5hour, 6hour, 7hour, 8hour, 10hour, 24hour, 48hour,72hour, 96hour on day 1 and day 5. | 
| Cmax | Cmax is the maximum plasma concentration of TQ-B3139 or metabolite(s). | 0hour, 1hour, 2hour, 3hour, 4hour, 5hour, 6hour, 7hour, 8hour, 10hour, 24hour, 48hour,72hour, 96hour on day 1 and day 5. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tmax | To characterize the pharmacokinetics of TQ-B3139 by assessment of time to reach maximum plasma concentration. | 0hour, 1hour, 2hour, 3hour, 4hour, 5hour, 6hour, 7hour, 8hour, 10hour, 24hour, 48hour,72hour, 96hour on day 1 and day 5. | 
| t1/2 | t1/2 is time it takes for the blood concentration of TQ-B3139 or metabolite(s) to drop by half. | 0hour, 1hour, 2hour, 3hour, 4hour, 5hour, 6hour, 7hour, 8hour, 10hour, 24hour, 48hour,72hour, 96hour on day 1 and day 5. | 
| Objective Response Rate (ORR) | Percentage of participants achieving complete response (CR) and partial response (PR). | up to 24 months | 
| Progression-free survival (PFS) | PFS defined as the time from first dose to the first documented progressive disease (PD) or death from any cause. | up to 24 months | 
| Disease control rate (DCR) | Percentage of participants achieving Complete Response (CR) and Partial Response (PR) and Stable Disease (SD). | up to 24 months | 
| Duration of response (DOR) | DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment. | up to 24 months |