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Trial Title:
A Clinical Study of TQB3912 Tablets in Patients With Advanced Malignant Tumor
NCT ID:
NCT05997342
Condition:
Advanced Malignant Neoplasm
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
TQB3912 tablets
Description:
TQB3912 is a small molecule Phosphorylated protein kinase inhibitor. Activation of the
pathway plays an important role in cell survival, proliferation, migration, and
differentiation.
Arm group label:
TQB3912 tablets
Summary:
This is a study to evaluate the maximum tolerated dose (MTD), occurrence of all adverse
events (AEs) and serious adverse events (SAEs), pharmacokinetic parameters and antitumor
effect of TQB3912 tablets in Chinese adult patients with advanced malignant neoplasm. The
study was divided into phase Ia and phase Ib, Phase Ia: Dose escalation period, to
evaluate the safety and tolerability of TQB3912 tablets, determine MTD; Phase Ib:
Effectiveness exploration period, to expand the safe and effective dose group, and to
recommend appropriate dosage and method for subsequent clinical research.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Subjects who voluntarily join the study, sign the informed consent form, and have
good compliance.
- Aged from 18 to 75 years; Eastern Cooperative Oncology Group performance status
score: 0-2; at least 3 months of expected survival period.
- Subjects with relapse advanced malignant solid tumors clearly diagnosed by pathology
and/or cytology.
- The function of main organs is normal.
- Subjects need to adopt effective methods of contraception.
Exclusion Criteria:
- Subjects with other malignancies currently or suffered within 3 years.
- Subjects with Grade 1 or above unhealed toxicity reaction of Common Terminology
Criteria for Adverse Events Version 5.0 due to previous antitumor treatment.
- Subjects who have received major surgical treatment, open biopsy or obvious
traumatic injury within 28 days before first administration.
- Subjects with long lasting wounds or fractures.
- Subjects with a history of psychotropic drug abuse unable to quit or with mental
disorders.
- Subjects with any severe and/or uncontrolled disease.
- Subjects who have received surgery, chemotherapy, radiotherapy or other anticancer
therapies 4 weeks before the first administration.
- Subjects who have taken Chinese patent medicines with anti-tumor indications in the
drug instructions that National Medical Products Administration approved within 2
weeks before the first administration.
- Subjects with pleural effusion, pericardial effusion or ascites that cannot be
controlled and need repeated drainage.
- Subjects who have participated in other clinical studies within 4 weeks before the
first administration.
- According to the judgment of the investigators, there are accompanying diseases that
seriously endanger the safety of patients or affect the completion of the study.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Zip:
410013
Country:
China
Contact:
Last name:
Quchang Ouyang, Doctor
Phone:
+86 13973135318
Email:
oyqc1969@126.com
Facility:
Name:
West China hospital, Sichuan university
Address:
City:
Chengdu
Zip:
610000
Country:
China
Contact:
Last name:
Qiang Wei, Doctor
Phone:
+86 028-85422449
Email:
wq933@hotmail.com
Contact backup:
Last name:
Ping Feng, Doctor
Phone:
+86 028-85423583
Email:
617130961@qq.com
Start date:
August 2023
Completion date:
August 2025
Lead sponsor:
Agency:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Agency class:
Industry
Source:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05997342
