Status:
UNKNOWN
A Study to Evaluate the Tolerance, Efficacy and Pharmacokinetics of TQB3454 Tablets
Lead Sponsor:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Conditions:
Advanced Solid Tumor or Hematologic Tumor
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
This is a open-label, multicenter, phase I study to evaluate tolerance and pharmacokinetics of TQB3454 tablets in subjects with advanced solid tumor or hematologic tumor.
Eligibility Criteria
Inclusion
- \- 1. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1; Life expectancy ≥12 weeks.
- 2\. Advanced solid tumors or hematological malignancy. 3. Adequate laboratory indicators. 4. No pregnant or breastfeeding women, and a negative pregnancy test. 5. Understood and Signed an informed consent form.
Exclusion
- 1\. Has central nervous system metastasis or system leukemia. 2.Previous anti-tumor treatment:
- Has received IDH1 mutation inhibitor.
- Has received systemic anti-tumor therapy or radiotherapy within 14 days before the first dose.
- Has received oral targeted drugs, less than 5 drug half-lives from first dose.
- The related toxicity of previous anti-tumor therapy has not recovered to CTCAE ≤ grade 2, except for hair loss.
- Complicated disease and medical history:
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- Active hepatitis B or hepatitis C.
- Abnormal kidney.
- Abnormal cardiovascular and cerebrovascular.
- Abnormal gastrointestinal.
- Has medical history of immunodeficiency.
- Has bleeding (hemoptysis), coagulopathy, or been using warfarin, aspirin, and other antiplatelet agglutination drugs.
- Has uncontrollable systemic bacterial, fungal or viral active infections.
- Has medical history of idiopathic pulmonary fibrosis,or tissue pneumonia.
- Has allergic constitution or previous severe allergy; or known allergy to ingredients of study drug.
- Has neurological or mental disorders.
- Has a history of drug abuse or drug addict.
- Has received major surgery, open biopsy, or obvious traumatic injury within 4 weeks before the first dose.
- According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
- 4\. Has participated in other clinical trials within 30 days before participating in this trial.
- 5\. Female patients during pregnancy or lactation. 6. According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
- 7\. criteria for solid tumors:
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- Has any signs of bleeding constitution.
- Has any CTCAE ≥ grade 3 bleeding or bleeding event,within 4 weeks before the first dose.
- Has unhealed wounds, fractures, active ulcers of the stomach and duodenum, ulcerative colitis and other digestive tract diseases.
- Imaging (CT or MRI) shows that the tumor has invaded the circumference of important blood vessels.
- Has uncontrollable pleural effusion, pericardial effusion or ascites that still need repeated drainage.
- criteria for blood tumor:
- a) Has severe life-threatening leukemia complications.
Key Trial Info
Start Date :
August 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT04481607
Start Date
August 24 2020
End Date
December 31 2022
Last Update
January 10 2022
Active Locations (5)
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1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100089
2
The Affiliated Hosptial of Xuzhou Medical University
Xuzhou, Jiangsu, China, 221000
3
Tianjing Medical University Cancer Institute&Hospital
Tianjin, Tianjin Municipality, China, 300020
4
Hematology Hospital of Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China, 300041