Advanced Malignant Tumor
Conditions
Brief summary
The objective of this study is to evaluate efficacy and safety of TQ-B3101 in subjects with advanced malignant tumor.
Interventions
DRUGTQ-B3101
TQ-B3101 is a ALK inhibitor.
Sponsors
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate (ORR) | up to 48 weeks | Percentage of subjects achieving complete response (CR) and partial response (PR). |
| Adverse events (AE) and serious adverse events (SAE) | up to 48 weeks | The occurrence of all adverse events (AE) and serious adverse events (SAE). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival (PFS) | up to 48 weeks | PFS defined as the time from first dose until the first documented progressive disease (PD) or death from any cause. |
| Disease control rate (DCR) | up to 48 weeks | Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD). |
| Overall survival (OS) | up to 48 weeks | 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. |
Countries
China
Contacts
Primary ContactHongming Pan, Doctor
Outcome results
None listed