Actively Recruiting
A Clinical Trial on the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TQB3019 Capsule in Subjects With Advanced Malignant Tumors
Led by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Updated on 2026-02-12
80
Participants Needed
15
Research Sites
183 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The trial was divided into two phases: dose escalation and dose expansion. The dosing regimens were single-dose study and continuous dosing study. A single-center, open, non-randomized, single-arm clinical trial design was adopted. Subjects with advanced malignant tumors were selected to take TQB3019 capsules orally to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of TQB3019 capsules.
CONDITIONS
Official Title
A Clinical Trial on the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TQB3019 Capsule in Subjects With Advanced Malignant Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects voluntarily joined the study, signed informed consent form, and with good compliance.
- 18 years old or older; Eastern Cooperative Oncology Group (ECOG) physical status: 0-2; at least 3 months expected survival period.
- Clearly diagnosed recurrent or refractory hematological tumors per World Health Organization (WHO) definition.
- At least 1 measurable lesion for efficacy evaluation.
- Normal main organ functions.
- Female patients of childbearing age must agree to use contraception during the study and for at least 6 months after; negative serum pregnancy test within 7 days before enrollment; must not be lactating.
- Male patients must agree to use contraception during the study and for at least 6 months after.
You will not qualify if you...
- Had or currently have other malignant tumors within 3 years, except certain treated tumors with 5 years disease-free survival and specific non-invasive cancers.
- Central nervous system involvement.
- Received allogeneic hematopoietic stem cell transplantation or have active graft-versus-host disease needing immunosuppressive therapy within 12 months before first dose.
- Conditions affecting oral medication absorption such as inability to swallow, chronic diarrhea, or intestinal obstruction.
- Unresolved toxicity of grade 1 or higher from prior treatment, excluding alopecia and fatigue.
- Major surgery, open biopsy, or significant trauma within 28 days before study treatment.
- Active or uncontrolled autoimmune cytopenia including autoimmune hemolytic anemia and primary immune thrombocytopenia.
- History or evidence of bleeding disorders or significant bleeding events within 4 weeks before first medication.
- Arteriovenous thrombosis event within 6 months.
- History of psychotropic substance abuse or mental disorders preventing abstinence.
- Severe or uncontrolled diseases.
- Received anti-tumor proprietary Chinese medicines within 2 weeks before first treatment.
- Previously treated with drugs similar to TQB3019 capsules.
- Uncontrolled pleural, pericardial effusion, or ascites requiring repeated drainage.
- Received live or messenger RNA vaccines within 4 weeks before first treatment or planned during study.
- Participation in other antitumor drug trials within 4 weeks before first treatment.
- Investigator judgment of concomitant diseases seriously endangering safety or affecting study completion or other unsuitability for enrollment.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 15 locations
1
Cancer Institute & Hospital.Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
Not Yet Recruiting
2
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510515
Not Yet Recruiting
3
The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
Zhengzhou, Henan, China, 450000
Actively Recruiting
4
Jiangsu Province Hospital
Nanjing, Jiangsu, China, 210029
Not Yet Recruiting
5
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006
Not Yet Recruiting
6
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China, 710061
Not Yet Recruiting
7
Heze Municipal Hospital
Heze, Shandong, China, 27400
Not Yet Recruiting
8
The Cancer Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, China, 250117
Not Yet Recruiting
9
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China, 266075
Not Yet Recruiting
10
Tongji Hospital of Tongji University
Shanghai, Shanghai Municipality, China, 200065
Not Yet Recruiting
11
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, China, 646099
Not Yet Recruiting
12
Mianyang Central Hospital
Mianyang, Sichuan, China, 621000
Not Yet Recruiting
13
Affiliated Hospital of North sichuan Medical college
Nanchong, Sichuan, China, 637000
Not Yet Recruiting
14
TianJin Medical University Cancer Institute&Hospital
Tianjin, Tianjin Municipality, China, 300000
Not Yet Recruiting
15
Institute of Hematology ＆Blood Diseases Hospital,Chinese Academy of Medical Sciences ＆Peking Union Medical College
Tianjin, Tianjin Municipality, China, 301617
Not Yet Recruiting
Research Team
Z
Zengjun Li, Doctor
CONTACT
Y
Yvping Sun, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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