Last updated: September 18, 2021
Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Overall Status: Active - Recruiting
Phase
1
Condition
Neoplasms
Metastatic Cancer
Treatment
N/AClinical Study ID
NCT05028218
TQB3824-I-01
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Understood and signed an informed consent form;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1;
- Life expectancy >=3 months;
- Progressed after standard treatment or no standard treatment with an establishedsurvival benefit is available;
- Adequate organ/system function;
- Female patients of childbearing age should agree to use contraceptive measures duringthe study period and for at least 6 months after study is stopped; male patientsshould agree to use contraception during the study period and for at least 6 monthsafter study is stopped.
Exclusion
Exclusion Criteria:
- Diagnosed and/or treated additional malignancy within 3 years before the first dose;
- With factors affecting oral medication;
- Toxicity that is >=Grade 2 caused by previous cancer therapy;
- Received major surgical treatment, open biopsy or obvious traumatic injury within 28days before the first dose;
- Arterial thromboembolism and/or venous thromboembolism within 6 months;
- A history of psychotropic drug abuse or have a mental disorder;
- Any severe and/or uncontrolled disease;
- Has received surgery, chemotherapy, radiotherapy or other anticancer therapies 4 weeksbefore the first dose;
- Has received Chinese patent medicines with anti-tumor indications that NationalMedical Products Administration (NMPA) approved within 2 weeks before the first dose;
- Has received CDC7 inhibitors;
- Pleural effusion, pericardial effusion or ascites that cannot be controlled and needrepeated drainage;
- Brain metastases ;
- Has participated in other clinical studies within 4 weeks before the first dose;
- According to the judgement of the researchers, there are other factors that subjectsare not suitable for the study.
Study Design
Total Participants: 65
Study Start date:
August 31, 2021
Estimated Completion Date:
December 31, 2024
Connect with a study center
Tianjin Medical University Cancer Institution & Hospital
Tianjin, Tianjin 300181
ChinaActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.