A Clinical Study of TQB3824 in Subjects With Advanced Cancer

CTTQ

Status and phase: Enrolling; Phase 1

Conditions: Advanced Cancer

Treatments: Drug: TQB3824 tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT05028218

TQB3824-I-01

Details and patient eligibility

About

TQB3824 blocks function of a specific protein called Cell Division Cycle 7 (CDC7) kinase in the human body, which plays important roles in the maintenance of DNA replication forks and DNA damage response pathways. This study will evaluate the safety, tolerability and pharmacokinetics of TQB3824.

Enrollment: 65 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Understood and signed an informed consent form;
2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1;
3. Life expectancy >=3 months;
4. Progressed after standard treatment or no standard treatment with an established survival benefit is available;
5. Adequate organ/system function;
6. Female patients of childbearing age should agree to use contraceptive measures during the study period and for at least 6 months after study is stopped; male patients should agree to use contraception during the study period and for at least 6 months after study is stopped.

Exclusion criteria

1. Diagnosed and/or treated additional malignancy within 3 years before the first dose;
2. With factors affecting oral medication;
3. Toxicity that is >=Grade 2 caused by previous cancer therapy;
4. Received major surgical treatment, open biopsy or obvious traumatic injury within 28 days before the first dose;
5. Arterial thromboembolism and/or venous thromboembolism within 6 months;
6. A history of psychotropic drug abuse or have a mental disorder;
7. Any severe and/or uncontrolled disease;
8. Has received surgery, chemotherapy, radiotherapy or other anticancer therapies 4 weeks before the first dose;
9. Has received Chinese patent medicines with anti-tumor indications that National Medical Products Administration (NMPA) approved within 2 weeks before the first dose;
10. Has received CDC7 inhibitors;
11. Pleural effusion, pericardial effusion or ascites that cannot be controlled and need repeated drainage;
12. Brain metastases ;
13. Has participated in other clinical studies within 4 weeks before the first dose;
14. According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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65 participants in 1 patient group

TQB3824 tablets

Experimental group

Description:

TQB3824 tablets orally administrated orally on Days 1-21 of each 21-day treatment cycle. Dose escalation of TQB3824 will be based on evaluation of clinical safety and tolerability and guided by accumulating PK data

Treatment:

Drug: TQB3824 tablets