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

Phase 2

• Conditions: Advanced Malignant Tumor
• Interventions: Drug: TQ-B3101

• Registration Number: NCT04412564
• Lead Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-28
• Study First Submitted QC: 2020-05-28
• Study First Posted: 2020-06-02
• Status Verified: 2020-08
• Study Start: 2020-08-05
• Last Update Submitted: 2020-08-16
• Last Update Posted: 2020-08-18
• Primary Completion: 2021-03-31
• Study Completion: 2021-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

  2. Has a history of hypertension, hypertensive encephalopathy or uncontrolled hypertension.

  3. Has cardiovascular and cerebrovascular diseases. 6. Has received radiotherapy, chemotherapy, surgery less than 4 weeks before the first dose.

  4. Has central nervous system metastasis and / or spinal cord compression, cancerous meningitis, and meningeal disease.

  5. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TQ-B3101 capsules	TQ-B3101	TQ-B3101 capsules 300mg bid administered orally in 28-day cycle.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Disease control rate (DCR)	up to 48 weeks	Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).
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.
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.

Trial Locations

Locations (36)

Anhui Chest Hospital; 🇨🇳 Hefei, Anhui, China

The Second Hospital of Anhui medical University; 🇨🇳 Hefei, Anhui, China

Cancer Hospital Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China

The Fifth Medical Center of PLA Ceneral Hospital; 🇨🇳 Beijing, Beijing, China

Beijing Tsinghua Changgung Hospital; 🇨🇳 Beijing, Beijing, China

Fujian Provincial Cancer Hospital; 🇨🇳 Fuzhou, Fujian, China

Cancer Center of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China

The First Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China

Liuzhou People's Hospital; 🇨🇳 Liuzhou, Guangxi Zhuang Autonomous Region, China

Harbin Medical University Cancer Hospital; 🇨🇳 Harbin, Heilongjiang, China

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