A Clinical Study of TQB3824 in Subjects With Advanced Cancer

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/A

Clinical Study ID

NCT05028218
TQB3824-I-01
  • Ages 18-75
  • All Genders

Study 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

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 establishedsurvival benefit is available;
  5. Adequate organ/system function;
  6. 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:

  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 28days 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 weeksbefore the first dose;
  9. Has received Chinese patent medicines with anti-tumor indications that NationalMedical 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 needrepeated 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 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
    China

    Active - Recruiting

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