Clinical trial NCT05028218: A Clinical Study of TQB3824 in Subjects With Advanced Cancer
Official title: A Phase I Study to Evaluate the Safety and Pharmacokinetics of TQB3824 in Subjects With Advanced Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Advanced Cancer
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-08-31
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Dose-limiting toxicity (DLT)
timeFrame: up to 18 months
measure: Maximum Tolerated Dose (MTD)
timeFrame: up to 18 months
measure: Recommended Phase II Dose (RP2D)
timeFrame: up to 18 months
Secondary outcomes:
measure: Area under the plasma concentration-time curve (AUC)
timeFrame: up to 18 months
measure: Maximum (peak) plasma drug concentration (Cmax)
timeFrame: up to 18 months
measure: Time to reach maximum(peak )plasma concentration following drug administration (Tmax)
timeFrame: up to 18 months
measure: Overall response rate (ORR)
timeFrame: Baseline up to 12 months
measure: Disease Control Rate (DCR )
timeFrame: Baseline up to 12 months
measure: Duration of Response (DOR)
timeFrame: Baseline up to 12 months
measure: Progression-free survival (PFS)
timeFrame: Baseline up to 12 months
measure: Overall survival (OS)
timeFrame: Baseline up to 12 months
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institution & Hospital
state: Tianjin
Study officials:
References: