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NCT Number: NCT05997342

A Clinical Study of TQB3912 Tablets in Patients With Advanced Malignant Tumor

This is a study to evaluate the maximum tolerated dose (MTD), occurrence of all adverse events (AEs) and serious adverse events (SAEs), pharmacokinetic parameters and antitumor effect of TQB3912 tablets in Chinese adult patients with advanced malignant neoplasm. The study was divided into phase Ia and phase Ib, Phase Ia: Dose escalation period, to evaluate the safety and tolerability of TQB3912 tablets, determine MTD; Phase Ib: Effectiveness exploration period, to expand the safe and effective dose group, and to recommend appropriate dosage and method for subsequent clinical research.

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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

Hunan Cancer Hospital, Changsha, Hunan, 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

  • Subjects who voluntarily join the study, sign the informed consent form, and have good compliance.
  • Aged from 18 to 75 years; Eastern Cooperative Oncology Group performance status score: 0-2; at least 3 months of expected survival period.
  • Subjects with relapse advanced malignant solid tumors clearly diagnosed by pathology and/or cytology.
  • The function of main organs is normal.
  • Subjects need to adopt effective methods of contraception.

Exclusion criteria

  • Subjects with other malignancies currently or suffered within 3 years.
  • Subjects with Grade 1 or above unhealed toxicity reaction of Common Terminology Criteria for Adverse Events Version 5.0 due to previous antitumor treatment.
  • Subjects who have received major surgical treatment, open biopsy or obvious traumatic injury within 28 days before first administration.
  • Subjects with long lasting wounds or fractures.
  • Subjects with a history of psychotropic drug abuse unable to quit or with mental disorders.
  • Subjects with any severe and/or uncontrolled disease.
  • Subjects who have received surgery, chemotherapy, radiotherapy or other anticancer therapies 4 weeks before the first administration.
  • Subjects who have taken Chinese patent medicines with anti-tumor indications in the drug instructions that National Medical Products Administration approved within 2 weeks before the first administration.
  • Subjects with pleural effusion, pericardial effusion or ascites that cannot be controlled and need repeated drainage.
  • Subjects who have participated in other clinical studies within 4 weeks before the first administration.
  • According to the judgment of the investigators, there are accompanying diseases that seriously endanger the safety of patients or affect the completion of the study.

Treatment and study plan

TQB3912 tablets

Drug

TQB3912 is a small molecule Phosphorylated protein kinase inhibitor. Activation of the pathway plays an important role in cell survival, proliferation, migration, and differentiation.

Primary outcomes

  1. Dose Limiting Toxicities (DLT)

    Time frame: During the first 28 days.

    Subjects within 28 days after treatment appear the following toxicity reaction relate to the drug: grade III or above of non-hematological toxicity, grade III hematological toxicity, Neutropenia associated with fever.

  2. Maximum tolerated dose (MTD)

    Time frame: During the first 29 days.

    MTD is defined as the highest dosing schedule cohort level at which no more than 1 of 6 patients experience a Dose Limiting Toxicity (DLT).

  3. Overall response rate (ORR)

    Time frame: Up to 2 years

    From the first drug treatment to the last drug treatment.

Secondary outcomes

  1. Incidence of adverse events (AEs)

    Time frame: From the time of informed consent signed to 90 days after the last dose

    Number of patients with adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0

  2. Incidence of serious adverse events (SAEs)

    Time frame: From the time of informed consent signed to 90 days after the last dose

    Number of patients with serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0

  3. Disease control rate (DCR)

    Time frame: Up to 2 years

    The proportion of subjects with Complete response (CR), Partial response (PR), or Stable Disease (SD).

  4. Progression-free survival (PFS)

    Time frame: Up to 2 years

    The time from the first dose of TQB3912 to the first occurrence of disease progression or death from any cause.

  5. Duration of Response (DOR)

    Time frame: Up to 2 years

    The time from first documented response to documented disease progression.

  6. Overall survival (OS)

    Time frame: Up to 5 years

    The time between the date of first administration and the date of death due to any cause.

  7. Time to reach maximum (peak) plasma concentration (Tmax)

    Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48 and 72 hours after-dose on single dose; pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48 and 72 hours after-dose on multiple dose of day 28.

    To characterize the pharmacokinetics of TQB3912 by assessment of time to reach maximum plasma concentration after single and multiple dosing.

  8. Maximum (peak) plasma drug concentration (Cmax)

    Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48 and 72 hours after-dose on single dose; pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48 and 72 hours after-dose on multiple dose of day 28.

    Cmax is the maximum plasma concentration of TQB3912 or metabolite(s).

  9. Maximum (peak) steady-state plasma drug concentration during a dosage interval (Cmax,ss)

    Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48 and 72 hours after-dose on single dose; pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48 and 72 hours after-dose on multiple dose of day 28.

    Cmax,ss is the maximum steady-state plasma concentration of TQB3912 or metabolite(s).

  10. Area under the plasma concentration-time curve from time zero to time t (AUC0-t)

    Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48 and 72 hours after-dose on single dose; pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48 and 72 hours after-dose on multiple dose of day 28.

    To characterize the pharmacokinetics of TQB3912 by assessment of area under the plasma concentration time curve from the first dose to time t.

  11. Elimination half-life (t1/2) (to be used in one-or non- compartmental model)

    Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48 and 72 hours after-dose on single dose; pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48 and 72 hours after-dose on multiple dose of day 28.

    t1/2 is time it takes for the blood concentration of TQB3912 or metabolite(s) to drop by half.

Sponsors and collaborators

Lead sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Industry

Registry information

Official study title

A Phase I Clinical Trial to Evaluate the Safety and Tolerability of TQB3912 Tablets in Subjects With Advanced Malignancies

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 18, 2023
Registry last updated
Aug 11, 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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