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Completed

NCT Number: NCT06344351

A Clinical Trial of TQB3006 Tablets in Patients With Advanced Malignant Cancer

This study includes two stage: dose escalation and dose extension, with a single dose and a multiple dose study. This is a single-center, open, non-randomized, single arm, study to evaluate the safety, tolerability and pharmacokinetics of TQB3006 tables in patients with advanced malignant cancer.

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Key information

Conditions

Advanced Malignant Neoplasm

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Anhui Provincial Hospital, Hefei, Anhui, China

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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;
  • Female patient had no plans to become pregnant and voluntarily took effective contraceptive measures during the study period to at least 6 months after the last dose of study drug.

Exclusion criteria

  • There were other malignant tumors within 3 years;
  • Has multiple factors affecting oral medication;
  • Unalleviated toxicity ≥ grade 1 of 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 including active hepatitis, a history of immunodeficiency, etc.;
  • Tumor-related symptoms and treatment:
  • 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 1 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

TQB3006 tablets

Drug

TQB3006 is an inhibitor protein.

Primary outcomes

  1. Dose limiting toxicity (DLT)

    Time frame: At the end of Cycle 1 (21 Days).

    DLT will be defined as toxicities that meet pre-defined severity criteria (according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version5.0), and assessed as having a suspected relationship to study drug that occurred from first medication to the end of the first treatment cycle.

  2. Maximum tolerated dose (MTD)

    Time frame: At the end of Cycle 1 (21 Days).

    MTD was 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 TQB3006 tablets in adult patients with Advanced Malignant Cancer

Secondary outcomes

  1. Adverse events (AE)

    Time frame: 30 days after the last dose.

    The occurrence of all adverse events (AE).

  2. Serious adverse events (SAE)

    Time frame: 30 days after the last dose.

    The occurrence of all serious adverse events (SAE).

  3. Time to reach maximum plasma concentration (Tmax)

    Time frame: Day 1: pre-dose, at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 hours after-dose. Cycle 1 Day 1,Cycle 1 Day 7,Cycle 1 Day 14, Cycle 1 Day 21: pre-dose, Cycle 1 Day 21: at 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours after-dose. Each cycle is 21 days.

    To characterize the pharmacokinetics of TQB3006 by assessment of time to reach maximum plasma concentration after single and multiple dosing.

  4. Peak concentration (Cmax)

    Time frame: Day 1: pre-dose, at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 hours after-dose. Cycle 1 Day 1,Cycle 1 Day 7,Cycle 1 Day 14, Cycle 1 Day 21: pre-dose, Cycle 1 Day 21: at 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours after-dose. Each cycle is 21 days.

    The maximum observed plasma concentration of study drug. Each cycle is 21 days.

  5. Half-life (t1/2)

    Time frame: Day 1: pre-dose, at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 hours after-dose. Cycle 1 Day 1,Cycle 1 Day 7,Cycle 1 Day 14, Cycle 1 Day 21: pre-dose, Cycle 1 Day 21: at 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours after-dose. Each cycle is 21 days.

    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: pre-dose, at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 hours after-dose. Cycle 1 Day 1,Cycle 1 Day 7,Cycle 1 Day 14, Cycle 1 Day 21: pre-dose, Cycle 1 Day 21: at 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours after-dose. Each cycle is 21 days.

    Area under the concentration-time curve from zero to infinity

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

    Time frame: Day 1: pre-dose, at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 hours after-dose. Cycle 1 Day 1,Cycle 1 Day 7,Cycle 1 Day 14, Cycle 1 Day 21: pre-dose, Cycle 1 Day 21: at 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours after-dose. Each cycle is 21 days.

    Area under the concentration-time curve from the first dose to a certain time point.

  8. Apparent clearance (CL/F)

    Time frame: Day 1: pre-dose, at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 hours after-dose. Cycle 1 Day 1,Cycle 1 Day 7,Cycle 1 Day 14, Cycle 1 Day 21: pre-dose, Cycle 1 Day 21: at 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours after-dose. Each cycle is 21 days.

    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: pre-dose, at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 hours after-dose. Cycle 1 Day 1,Cycle 1 Day 7,Cycle 1 Day 14, Cycle 1 Day 21: pre-dose, Cycle 1 Day 21: at 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours after-dose. Each cycle is 21 days.

    Apparent volume of distribution of the TQB3006 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 100 weeks

    Defined as the percentage of patients with complete response (CR) or partial response (PR) assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.

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, Tolerance and Pharmacokinetics of TQB3006 Tablets in Patients With Advanced Malignant Cancer

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 3, 2024
Registry last updated
May 22, 2025

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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