NCT05028218

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
65

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2021

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 31, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

August 31, 2021

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

September 21, 2021

Status Verified

September 1, 2021

Enrollment Period

2.9 years

First QC Date

August 25, 2021

Last Update Submit

September 18, 2021

Conditions

Advanced Cancer

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (8)

  • Area under the plasma concentration-time curve (AUC)

    up to 18 months

  • Maximum (peak) plasma drug concentration (Cmax)

    up to 18 months

  • Time to reach maximum(peak )plasma concentration following drug administration (Tmax)

    up to 18 months

  • Overall response rate (ORR)

    Baseline up to 12 months

  • Disease Control Rate (DCR )

    Baseline up to 12 months

  • +3 more secondary outcomes

Study Arms (1)

TQB3824 tablets

EXPERIMENTAL

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

Interventions

TQB3824 tabletsDRUG

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

TQB3824 tablets

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Understood and signed an informed consent form;
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1;
  • Life expectancy \>=3 months;
  • Progressed after standard treatment or no standard treatment with an established survival benefit is available;
  • Adequate organ/system function;
  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Medical University Cancer Institution & Hospital

Tianjin, Tianjin Municipality, 300181, China

RECRUITING

Central Study Contacts

Jihui Hao, Doctor

CONTACT

022-23340123haojihui@tjmuch.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2021

First Posted

August 31, 2021

Study Start

August 31, 2021

Primary Completion

August 1, 2024

Study Completion

December 1, 2024

Last Updated

September 21, 2021

Record last verified: 2021-09

Locations

CN(1)