- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05997342
A Clinical Study of TQB3912 Tablets in Patients With Advanced Malignant Tumor
August 10, 2023 updated by: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
A Phase I Clinical Trial to Evaluate the Safety and Tolerability of TQB3912 Tablets in Subjects With Advanced Malignancies
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
88
Phase
- 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
- Name: Quchang Ouyang, Doctor
- Phone Number: +86 13973135318
- Email: oyqc1969@126.com
Study Contact Backup
- Name: Qiang Wei, Doctor
- Phone Number: +86 028-85422449
- Email: wq933@hotmail.com
Study Locations
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Hunan
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Changsha, Hunan, China, 410013
- Hunan Cancer Hospital
-
Contact:
- Quchang Ouyang, Doctor
- Phone Number: +86 13973135318
- Email: oyqc1969@126.com
-
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Sichuan
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Chengdu, Sichuan, China, 610000
- West China Hospital, Sichuan University
-
Contact:
- Qiang Wei, Doctor
- Phone Number: +86 028-85422449
- Email: wq933@hotmail.com
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Contact:
- Ping Feng, Doctor
- Phone Number: +86 028-85423583
- Email: 617130961@qq.com
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-
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
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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.
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TQB3912 tablets
TQB3912 tablets, 28 days as a treatment cycle.
|
TQB3912 is a small molecule Phosphorylated protein kinase inhibitor.
Activation of the pathway plays an important role in cell survival, proliferation, migration, and differentiation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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During the first 28 days.
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Maximum tolerated dose (MTD)
Time Frame: During the first 29 days.
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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).
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During the first 29 days.
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Overall response rate (ORR)
Time Frame: Up to 2 years
|
From the first drug treatment to the last drug treatment.
|
Up to 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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From the time of informed consent signed to 90 days after the last dose
|
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
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From the time of informed consent signed to 90 days after the last dose
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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).
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Up to 2 years
|
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.
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Up to 2 years
|
Duration of Response (DOR)
Time Frame: Up to 2 years
|
The time from first documented response to documented disease progression.
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Up to 2 years
|
Overall survival (OS)
Time Frame: Up to 5 years
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The time between the date of first administration and the date of death due to any cause.
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Up to 5 years
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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.
|
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.
|
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.
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Cmax is the maximum plasma concentration of TQB3912 or metabolite(s).
|
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.
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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.
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Cmax,ss is the maximum steady-state plasma concentration of TQB3912 or metabolite(s).
|
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.
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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.
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To characterize the pharmacokinetics of TQB3912 by assessment of area under the plasma concentration time curve from the first dose to time t.
|
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.
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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.
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t1/2 is time it takes for the blood concentration of TQB3912 or metabolite(s) to drop by half.
|
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.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 (Estimated)
August 1, 2023
Primary Completion (Estimated)
March 1, 2024
Study Completion (Estimated)
August 1, 2025
Study Registration Dates
First Submitted
August 10, 2023
First Submitted That Met QC Criteria
August 10, 2023
First Posted (Actual)
August 18, 2023
Study Record Updates
Last Update Posted (Actual)
August 18, 2023
Last Update Submitted That Met QC Criteria
August 10, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TQB3912-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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