Status:
COMPLETED
A Clinical Study of TQB3912 Tablets in Patients With Advanced Malignant Tumor
Lead Sponsor:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Conditions:
Advanced Malignant Neoplasm
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief 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 table...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 16 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 27 2025
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT05997342
Start Date
August 16 2023
End Date
May 27 2025
Last Update
August 11 2025
Active Locations (2)
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1
Hunan Cancer Hospital
Changsha, Hunan, China, 410013
2
West China hospital, Sichuan university
Chengdu, Sichuan, China, 610000