A Clinical Study to Evaluate the Tolerability and Pharmacokinetics of TQB3811 Tablets in Patients With Advanced Malignant Tumors

December 2, 2021 updated by: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Phase I Clinical Study to Evaluate the Tolerability and Pharmacokinetics of TQB3811 Tablets in Patients With Advanced Malignant Tumors

TQB3811 tablet is a second-generation tropomyosin receptor kinase (TRK) inhibitor that selectively inhibits the kinase activity of TRKA, TRKB, and TRKC, and also selectively inhibits the kinase activity of TRKA, TRKB, and TRKC that produce secondary drug-resistant mutations.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100142
        • Recruiting
        • Beijing Cancer Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with advanced malignancy diagnosed histologically and/or cytologically, who have failed standard treatment or are unable to receive standard treatment or have no effective treatment.
  • Age: 18~75 years old.
  • Women of childbearing age must be negative for serum or urine HCG within 7 days prior to study enrollment and must be non-lactating; Patients should agree to use contraception during the study period and for 6 months after the study period.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months.
  • Patients voluntarily joined the study and signed the informed consent, showing good compliance.

Exclusion Criteria:

  • Patients has had or is currently having other malignant tumors within 3 years.
  • Patients have multiple factors that affect their oral medication (such as inability to swallow, chronic diarrhea, and intestinal obstruction).
  • The patient had unmitigated toxic reactions due to any prior treatment.
  • Patients underwent major surgical treatment, open biopsy, or significant traumatic injury within 4 weeks prior to the start of study treatment.
  • Patients have long-term unhealed wounds or fractures.
  • The patient had experienced an arterial/venous thrombosis event in the past 6 months, such as a cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis, and pulmonary embolism.
  • The patient has a history of psychotropic drug abuse and cannot quit or has mental disorders.
  • Patients are taking cytochrome P450 3A (CYP3A) inhibitors or inducers.
  • Patients have uncontrolled pleural effusion, pericardial effusion, or ascites that still require repeated drainage.
  • Patients with brain metastases with symptoms or control of symptoms for less than 2 weeks.
  • The patients were currently breastfeeding or planned to breastfeed during the study period.
  • Patients who, in the investigator's judgment, have a comorbidity that seriously endangers patient safety or interferes with study completion, or who are considered unsuitable for inclusion for other reasons

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: TQB3811
The initial dose is 2.5mg, once a day (QD), and the medication stage is divided into single administration and continuous administration. The single administration is given once a day, and the continuous administration is entered 4 days after drug withdrawal. The drug is administered continuously until the disease progresses.
Drug: TQB3811
TQB3811 is a second-generation TrkA inhibitor.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Maximum tolerated dose (MTD)
Time Frame: Baseline up to 32 weeks
To evaluate MTD of TQB3811 tablets in Chinese adult patients with advanced solid tumors
Baseline up to 32 weeks
Adverse events (AEs) and serious adverse events (SAEs)
Time Frame: Baseline up to 28 days
The occurrence of all AEs and SAEs
Baseline up to 28 days
Dose-limiting toxicity (DLT)
Time Frame: Baseline up to 32 weeks
To evaluate DLT of TQB3811 tablets in Chinese adult patients with advanced solid tumors
Baseline up to 32 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Disease control rate（DCR）
Time Frame: up to 96 weeks
Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).
up to 96 weeks
Duration of Response (DOR)
Time Frame: up to 96 weeks
The time when the participants first achieved complete or partial remission to disease progression.
up to 96 weeks
Time to reach maximum (peak) plasma concentration following drug administration（Tmax）
Time Frame: 15, 30minutes, 1, 2, 4, 6, 8,10, 24, 48 hours after oral administration of day 1 and day 11;30 minutes before oral administration on day 1, day5, day7,day8 ,day 9 and day11.
To characterize the pharmacokinetics of TQB3811 by assessment of time to reach maximum plasma concentration after single and multiple dosing
15, 30minutes, 1, 2, 4, 6, 8,10, 24, 48 hours after oral administration of day 1 and day 11;30 minutes before oral administration on day 1, day5, day7,day8 ,day 9 and day11.
Maximum (peak) plasma drug concentration （Cmax）
Time Frame: 15, 30 minutes, 1, 2, 4, 6, 8,10, 24, 48 hours after oral administration of day 1 ;30 minutes before oral administration on day 1.
Cmax is the maximum plasma concentration of TQB3811 or metabolite(s).
15, 30 minutes, 1, 2, 4, 6, 8,10, 24, 48 hours after oral administration of day 1 ;30 minutes before oral administration on day 1.
Elimination half-life （t1/2）
Time Frame: 15, 30minutes, 1, 2, 4, 6, 8,10, 24, 48 hours after oral administration of day 1 and day 11;30 minutes before oral administration on day 1, day5, day7,day8 ,day 9 and day11.
t1/2 is time it takes for the blood concentration of TQB3811 or metabolite(s) to drop by half.
15, 30minutes, 1, 2, 4, 6, 8,10, 24, 48 hours after oral administration of day 1 and day 11;30 minutes before oral administration on day 1, day5, day7,day8 ,day 9 and day11.
Area under the plasma concentration-time curve from time zero to time t （AUC0-t）
Time Frame: 15, 30 minutes, 1, 2, 4, 6, 8,10, 24, 48 hours after oral administration of day 1 ;30 minutes before oral administration on day 1.
To characterize the pharmacokinetics of TQB3811 by assessment of area under the plasma concentration time curve from the first dose to infinity.
15, 30 minutes, 1, 2, 4, 6, 8,10, 24, 48 hours after oral administration of day 1 ;30 minutes before oral administration on day 1.
Maximum (peak) steady-state plasma drug concentration during a dosage interval （Cmax,ss）
Time Frame: 15, 30 minutes, 1, 2, 4, 6, 8,10, 24, 48 hours after oral administration of day 1 and day 11;30 minutes before oral administration on day 1, day5, day7,day8 ,day 9 and day11.
Cmax,ss is maximum (peak) steady-state plasma drug concentration during a dosage interval .
15, 30 minutes, 1, 2, 4, 6, 8,10, 24, 48 hours after oral administration of day 1 and day 11;30 minutes before oral administration on day 1, day5, day7,day8 ,day 9 and day11.
Minimum steady-state plasma drug concentration during a dosage interval （Css-min）
Time Frame: 15, 30 minutes, 1, 2, 4, 6, 8,10, 24, 48 hours after oral administration of day 1 and day 11;30 minutes before oral administration on day 1, day5, day7,day8 ,day 9 and day11.
Css-min is minimum steady-state plasma drug concentration during a dosage interval.
15, 30 minutes, 1, 2, 4, 6, 8,10, 24, 48 hours after oral administration of day 1 and day 11;30 minutes before oral administration on day 1, day5, day7,day8 ,day 9 and day11.
Concentration at the end of the dosing interval (AUCtau,ss)
Time Frame: 15, 30 minutes, 1, 2, 4, 6, 8,10, 24, 48 hours after oral administration of day 1 and day 11;30 minutes before oral administration on day 1, day5, day7,day8 ,day 9 and day11.
To characterize the pharmacokinetics of TQB3811 by assessment of area The concentration at the end of the administration interval
15, 30 minutes, 1, 2, 4, 6, 8,10, 24, 48 hours after oral administration of day 1 and day 11;30 minutes before oral administration on day 1, day5, day7,day8 ,day 9 and day11.
Progress Free Survival（PFS）
Time Frame: up to 96 weeks
From the start of randomization to the first tumor progression or time of death.
up to 96 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 30, 2021

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2022

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 13, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 16, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 3, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TQB3811-I-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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