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NCT Number: NCT06415903

A Clinical Trial of TQB3117 Tablets in Patients With Advanced Malignant Cancer

The study is divided into two phases: dose escalation and dose extension. The dosing regimens include a single-dose study and a multiple-dose study. It adopts a single-center, open-label, non-randomized, single-arm clinical trial design, where patients with advanced malignant cancer are selected to orally take TQB3117 tablets. The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of TQB3117 tablets in patients.

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Key information

Conditions

Advanced Malignant Cancer

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The First Affiliated Hospital of Shandong First Medical University

Jinan, Shandong, 250117, China

Location contact

Jinming Yu, Doctor

CONTACT

[email protected]

13806406293

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study;
  • Age: 18 to 75 years old; an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
  • Has at least one assessable lesion according to Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria;
  • The main organs function well;
  • Female patient had no plans to become pregnant and voluntarily took effective contraceptive measures from agree with the study to at least 6 months after the last dose of study drug.

Exclusion criteria

  • There were other malignant tumors in 3 years;
  • Has multiple factors affecting oral medication;
  • Unalleviated toxicity ≥ grade 1 above CTCAE v5.0 due to any previous therapy, excluding hair loss;
  • Major surgical treatment, open biopsy and obvious traumatic injury were performed within 28 days before the study, or have not fully recovered from previous surgery, or are expected to require major surgical surgery during the study period;
  • Arteriovenous thrombotic events occurred within 6 months, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism;
  • Have a history of psychotropic drug abuse and can not quit or have mental disorders;
  • Subjects with any severe and / or uncontrolled disease included: active hepatitis, have a history of immunodeficiency;
  • Has known symptomatic central nervous system metastases and/or cancerous meningitis;
  • Thoracic/abdominal/pericardial effusion with clinical symptoms or requiring repeated drainage, or drainage for the purpose of receiving treatment within one month after receiving the investigational drug for the first time;
  • Has participated in other clinical trials within 4 weeks before first dose;
  • According to the judgement of the investigators, there are other factors that may lead to the termination of the study.

Treatment and study plan

TQB3117 tablets

Drug

TQB3117 is a protein inhibitor.

Primary outcomes

  1. Dose Limiting Toxicity (DLT)

    Time frame: At the end of Cycle 1 (each cycle is 21 days)

    DLT refers to occurrence of drug-related adverse events within the first treatment cycle after subjects receive single-dose or multiple-dose treatment, as defined by the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 toxicity assessment criteria.

  2. Maximum tolerated dose (MTD)

    Time frame: At the end of Cycle 1 (each cycle is 21 days)

    MTD is defined as the highest dose at which dose-limiting toxicity (DLT) occurred in less than 33% of patients.

  3. Recommended Phase II Dose (RP2D)

    Time frame: Baseline up to 24 months

    DLT describes side effects of a drug or other treatment that are serious enough to evaluate RP2D of TQB3117 tablets in adult patients with advanced malignant cancer.

Secondary outcomes

  1. Adverse events (AE)

    Time frame: 30 days after the last administration

    The occurrence of all adverse events (AE).

  2. Serious adverse events (SAE)

    Time frame: 30 days after the last administration

    The occurrence of all serious adverse events (SAE).

  3. Time to reach maximum plasma concentration (Tmax)

    Time frame: Day 1 of single dose: pre-dose, at 0.5,1, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours after-dose. Days 7,14 and 21 of cycle1: pre-dose. Day 21of cycle1: at 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours after-dose.

    To characterize the pharmacokinetics of TQB3117 by assessment of time to reach maximum plasma concentration after single and multiple dosing.

  4. Peak concentration (Cmax)

    Time frame: Day 1 of single dose: pre-dose, at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours after-dose. Days 7,14 and 21 of cycle1: pre-dose. Day 21 of cycle 1: at 0.5,1, 2, 3, 4, 6, 8, 12, 24 hours after-dose.

    The maximum observed plasma concentration of study drug.

  5. Half-life (t1/2)

    Time frame: Day 1 of single dose: pre-dose, at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours after-dose. Days 7, 14 and 21 of cycle 1: pre-dose. Day 21 of cycle 1: at 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours after-dose.

    Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.

  6. Area under the concentration-time curve (AUC [0-infinity]

    Time frame: Day 1 of single dose: pre-dose, at 0.5,1, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours after-dose. Days 7, 14 and 21 of cycle 1: pre-dose, Day 21 of cycle 1: at 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours after-dose.

    To characterize the pharmacokinetics of TQB3117 by assessment of area under the plasma concentration time curve from 0 extrapolated to infinity.

  7. Area under the concentration-time curve (AUC [0-t]

    Time frame: Day 1 of single dose: pre-dose, at 0.5,1, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours after-dose. Days 7, 14 and 21 of cycle 1: pre-dose. Day 21 of cycle 1: at 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours after-dose.

    To characterize the pharmacokinetics of TQB3117 by assessment of area under the plasma concentration time curve from the first dose to a certain time point.

  8. Apparent clearance (CL/F)

    Time frame: Day 1 of single dose: pre-dose, at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours after-dose. Days 7, 14 and 21 of cycle 1: pre-dose. Day 21 of cycle 1: at 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours after-dose.

    Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body.

  9. Apparent volume of distribution (Vd/F)

    Time frame: Day 1 of single dose: pre-dose, at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours after-dose. Days 7, 14 and 21 of cycle 1: pre-dose. Day 21 of cycle 1: at 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours after-dose.

    Apparent volume of distribution of the TQB3117 in plasma.

  10. Objective Response Rate (ORR)

    Time frame: From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100weeks

    The percentage of complete response (CR) plus partial response (PR) assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria.

Study contacts

Contact information is provided by the study sponsor or research team.

Jinming Yu, Doctor

CONTACT

[email protected]

13806406293

Yuping Sun, Doctor

CONTACT

[email protected]

0531-67627156

Sponsors and collaborators

Lead sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Industry

Registry information

Official study title

A Phase I Study to Evaluate the Safety and Tolerance of TQB3117 Tablets in Patients With Advanced Malignant Cancer

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
May 16, 2024
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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