A Clinical Study of TQB3824 in Subjects With Advanced Cancer

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

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Cancer
• Intervention / Treatment: Drug: TQB3824 tablets

• Study Type: Interventional
• Enrollment (Anticipated): 65
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Jihui Hao, Doctor; Phone Number: 022-23340123; Email: haojihui@tjmuch.com

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300181
      • Recruiting
      • Tianjin Medical University Cancer Institution & Hospital
      • Contact: Jihui Hao, Doctor; Phone Number: 022-23340123; Email: haojihui@tjmuch.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TQB3824 tablets; 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	Drug: TQB3824 tablets; TQB3824 is a CDC7 inhibitor, which plays important roles in the maintenance of DNA replication forks and DNA damage response pathways.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Maximum Tolerated Dose (MTD)	The maximum Dose at which less than 33% subjects experiencing DLT	up to 18 months
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the plasma concentration-time curve (AUC)	Concentration Uncer Curve	up to 18 months
Maximum (peak) plasma drug concentration (Cmax)	Maximum plasma concentration of drug	up to 18 months
Time to reach maximum(peak )plasma concentration following drug administration (Tmax)	Time to Reach the Maximum Plasma Concentration	up to 18 months
Overall response rate (ORR)	The sum of percentage of participants with complete response rate and partial response rate	Baseline up to 12 months
Disease Control Rate (DCR )	percentage of participants with complete response (CR), partial response (PR) plus stable disease (SD)	Baseline up to 12 months
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
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
Overall survival (OS)	the time from start of study treatment to date of death due to any cause	Baseline up to 12 months

Collaborators and Investigators

• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2021
• Primary Completion (Anticipated): August 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: August 25, 2021
• First Submitted That Met QC Criteria: August 25, 2021
• First Posted (Actual): August 31, 2021

Study Record Updates

• Last Update Posted (Actual): September 21, 2021
• Last Update Submitted That Met QC Criteria: September 18, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: TQB3824-I-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No