A Study of TQ-B3101 Capsules in Subjects With Advanced Malignant Tumor

Study Overview
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Brief Summary
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The objective of this study is to evaluate efficacy and safety of TQ-B3101 in subjects with advanced malignant tumor.

Official Title
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A Open-label, Single-arm Phase Ⅱ Clinical Trial of TQ-B3101 Capsules in Subjects With Advanced Malignant Tumor

Conditions
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Advanced Malignant Tumor

Intervention / Treatment
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* Drug: TQ-B3101


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; Life expectancy ≥12 weeks. 2. Understood and signed an informed consent form. 3. Histologically or cytologically confirmed advanced malignant solid tumors. 4. Adequate organ system function. 5. Patients need to adopt effective methods of contraception. Exclusion Criteria: 1. Has multiple factors affecting oral medication. 2. The toxicity of previous antitumor treatment is not recovered to ≤ grade 1. 3. Other malignancies occurred within 3 years, with exception of cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors. 4. Has a history of hypertension, hypertensive encephalopathy or uncontrolled hypertension. 5. Has cardiovascular and cerebrovascular diseases. 6. Has received radiotherapy, chemotherapy, surgery less than 4 weeks before the first dose. 7. Has central nervous system metastasis and / or spinal cord compression, cancerous meningitis, and meningeal disease. 8. Active hepatitis, HIV positive, syphilis positive. 9. Has a history of psychotropic substance abuse. 10. 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TQ-B3101 capsules<br>TQ-B3101 capsules 300mg bid administered orally in 28-day cycle. | Drug: TQ-B3101<br>* TQ-B3101 is a ALK inhibitor.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate (ORR) | Percentage of subjects achieving complete response (CR) and partial response (PR). | up to 48 weeks | 
| Adverse events (AE) and serious adverse events (SAE) | The occurrence of all adverse events (AE) and serious adverse events (SAE). | up to 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival (PFS) | PFS defined as the time from first dose until the first documented progressive disease (PD) or death from any cause. | up to 48 weeks | 
| Disease control rate (DCR) | Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD). | up to 48 weeks | 
| Overall survival (OS) | OS defined as the time from randomization to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive. | up to 48 weeks |