A Study of TQ-B3101 Capsules in Subjects With Advanced Malignant Tumor
A Open-label, Single-arm Phase Ⅱ Clinical Trial of TQ-B3101 Capsules in Subjects With Advanced Malignant Tumor
1 other identifier
interventional
200
1 country
36
Brief Summary
The objective of this study is to evaluate efficacy and safety of TQ-B3101 in subjects with advanced malignant tumor.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2020
Shorter than P25 for phase_2
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 28, 2020
CompletedFirst Posted
Study publicly available on registry
June 2, 2020
CompletedStudy Start
First participant enrolled
August 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2021
CompletedAugust 18, 2020
August 1, 2020
8 months
May 28, 2020
August 16, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (3)
Progression free survival (PFS)
up to 48 weeks
Disease control rate (DCR)
up to 48 weeks
Overall survival (OS)
up to 48 weeks
Study Arms (1)
TQ-B3101 capsules
EXPERIMENTALTQ-B3101 capsules 300mg bid administered orally in 28-day cycle.
Interventions
Eligibility Criteria
You may qualify if:
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1; Life expectancy ≥12 weeks.
- \. 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.
You may not qualify if:
- \. 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.
- \. Has a history of hypertension, hypertensive encephalopathy or uncontrolled hypertension.
- \. Has cardiovascular and cerebrovascular diseases. 6. Has received radiotherapy, chemotherapy, surgery less than 4 weeks before the first dose.
- \. Has central nervous system metastasis and / or spinal cord compression, cancerous meningitis, and meningeal disease.
- \. 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
Anhui Chest Hospital
Hefei, Anhui, 230022, China
The Second Hospital of Anhui medical University
Hefei, Anhui, 230601, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021, China
The Fifth Medical Center of PLA Ceneral Hospital
Beijing, Beijing Municipality, 100071, China
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, 102218, China
Fujian Provincial Cancer Hospital
Fuzhou, Fujian, 350011, China
Cancer Center of Guangzhou Medical University
Guangzhou, Guangdong, 501195, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120, China
Liuzhou People's Hospital
Liuchow, Guangxi, 545006, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150000, China
AnYang Tumor Hospital
Anyang, Henan, 455000, China
Luoyang Central Hospital Affiliated to Zhenghzou University
Luoyang, Henan, 471009, China
Nanyang First People's Hospital
Nanyang, Henan, 473000, China
Henan Provincial People's Hospital
Zhengzhou, Henan, 450003, China
Henan Cancer Hospital
Zhengzhou, Henan, 450008, China
Hubei Cancer Hospital
Wuhan, Hubei, 430079, China
Xiangyang First People's Hospital
Xiangyang, Hubei, 441099, China
Hunan Cancer Hospital
Changsha, Hunan, 410006, China
Jiangsu Province Hospital
Nanjing, Jiangsu, 210000, China
Nanjing First Hospital
Nanjing, Jiangsu, 210000, China
The Second Hospital of Dalian Medical University
Dalian, Liaoning, 116027, China
Weihai Central Hospital
Weihai, Shandong, 264400, China
Shanghai Jiaotong University Affiliated Chest Hospital
Shanghai, Shanghai Municipality, 200030, China
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080, China
Shanxi Bethuen Hospital
Taiyuan, Shanxi, 030000, China
The Second Affiliated Hospital of PLA Air Force Military Medical University
Xi’an, Shanxi, 710038, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 710061, China
Xi'an Chest Hospital
Xi’an, Shanxi, 710100, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060, China
The First People's Hospital of Kashgar Prefecture
Kashgar Prefecture, Xinjiang Uygur Autonomous Region, 844000, China
First Affiliated Hospital, School of Medicine, Shihezi University
Shihezi, Xinjiang Uygur Autonomous Region, 832000, China
First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang Uygur Autonomous Region, 830011, China
The Affiliated Cancer Hospital of Xinjiang Medical University
Ürümqi, Xinjiang Uygur Autonomous Region, 830011, China
Sir Run Run Shaw Hospital, Zhejiang University
Hangzhou, Zhejiang, 310016, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 28, 2020
First Posted
June 2, 2020
Study Start
August 5, 2020
Primary Completion
March 31, 2021
Study Completion
September 1, 2021
Last Updated
August 18, 2020
Record last verified: 2020-08