A Clinical Study of TQB3824 in Subjects With Advanced Cancer

Advanced Cancer Clinical Trial

Official title:

A Phase I Study to Evaluate the Safety and Pharmacokinetics of TQB3824 in Subjects With Advanced Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05028218
• Other study ID #: TQB3824-I-01
• Status: Recruiting
• Phase: Phase 1
• Start date: August 31, 2021
• Est. completion date: December 2024

Study information

• Verified date: September 2021
• Source: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Contact: Jihui Hao, Doctor
• Phone: 022-23340123
• Email: haojihui[@]tjmuch.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 65
• Est. completion date: December 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Cancer
• Neoplasms

Intervention

Drug:
• TQB3824 tablets
TQB3824 is a CDC7 inhibitor, which plays important roles in the maintenance of DNA replication forks and DNA damage response pathways.

Locations

Country	Name	City	State
China	Tianjin Medical University Cancer Institution & Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose-limiting toxicity (DLT)	DLT describes side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment.	up to 18 months
Primary	Maximum Tolerated Dose (MTD)	The maximum Dose at which less than 33% subjects experiencing DLT	up to 18 months
Primary	Recommended Phase II Dose (RP2D)	RP2D will be based on evaluation of clinical safety and tolerability and guided by accumulating PK data	up to 18 months
Secondary	Area under the plasma concentration-time curve (AUC)	Concentration Uncer Curve	up to 18 months
Secondary	Maximum (peak) plasma drug concentration (Cmax)	Maximum plasma concentration of drug	up to 18 months
Secondary	Time to reach maximum(peak )plasma concentration following drug administration (Tmax)	Time to Reach the Maximum Plasma Concentration	up to 18 months
Secondary	Overall response rate (ORR)	The sum of percentage of participants with complete response rate and partial response rate	Baseline up to 12 months
Secondary	Disease Control Rate (DCR )	percentage of participants with complete response (CR), partial response (PR) plus stable disease (SD)	Baseline up to 12 months
Secondary	Duration of Response (DOR)	the time from the date of first documentation of a CR or PR to the date of first documentation of tumor progression	Baseline up to 12 months
Secondary	Progression-free survival (PFS)	Time from the first dose to the first documentation of PD or death from any cause, whichever occurs first	Baseline up to 12 months
Secondary	Overall survival (OS)	the time from start of study treatment to date of death due to any cause	Baseline up to 12 months