- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05110807
A Clinical Study to Evaluate the Tolerability and Pharmacokinetics of TQB3617 Capsule in Patients With Advanced Malignant Tumors
February 11, 2022 updated by: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Phase I Clinical Study to Evaluate the Tolerability and Pharmacokinetics of TQB3617 Capsule in Patients With Advanced Malignant Tumors
TQB3617 is a bromodomain and extra-terminal (BET) inhibitor that can competitively bind to bromodomains (BRDs) with Acetylated lysine(Kac) and block or partially block the role of KAc in subsequent gene transcription and regulation of chromatin structure, thereby playing an anti-tumor role.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
38
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: Xiaojia Wang, Master
- Phone Number: 0571-88122146
- Email: huang_jian22@aliyun.com
Study Locations
-
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Guangdong
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Guangzhou, Guangdong, China, 510060
- Recruiting
- Sun Yat-sen University Cancer Cen
-
Contact:
- Qingqing Cai, Doctor
- Phone Number: 020-87343356
- Email: caiqq@sysucc.org.cn
-
-
Zhejiang
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Hangzhou, Zhejiang, China, 31002
- Recruiting
- Zhejiang Cancer Hospital
-
Contact:
- Xiaojia Wang, Master
- Phone Number: 0571-88122146
- Email: huang_jian22@aliyun.com
-
-
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
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Aged: ≥18 years old.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Life expectancy ≥ 3 months.
- Patients with advanced malignancy tumor who have failed standard treatment or are unable to receive standard treatment or have no effective treatment.
- Female and male subjects should agree to use an adequate method of contraception starting with signing informed consent form (ICF) through 180 days after the last dose of study. The women of reproductive age who blood/urine results were positivetherapy before the first study drug is administered within less than 7 days.
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.
- Patients were taking Cytochrome P450 3A4, Cytochrome P450 3A5, Cytochrome P450 2A6, Cytochrome P450 2D6 (CYP3A4, CYP3A5, CYP2A6,CYP2D6) inhibitors or inducers before oral medication.
- 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 |
Intervention / Treatment |
---|---|
EXPERIMENTAL: TQB3617
0.1mg, once daily, was used as the initial dose, and the medication stage was divided into single administration and continuous administration stages.
The single administration was given once, and the continuous administration stage was entered 7 days after drug withdrawal.
The drug was administered continuously until the disease progressed.
|
TQB3617 is a BET inhibitor.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum tolerated dose (MTD)
Time Frame: Baseline up to 48 weeks
|
The highest dose of a drug or treatment that does not cause unacceptable side effects.
|
Baseline up to 48 weeks
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Adverse events (AEs) and serious adverse events (SAEs)
Time Frame: Baseline up to 48 weeks
|
The occurrence of all AEs and SAEs
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Baseline up to 48 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall response rate (ORR)
Time Frame: up to 96 weeks
|
Percentage of participants achieving complete response (CR) and partial response (PR).
|
up to 96 weeks
|
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).
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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.
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up to 96 weeks
|
Progress Free Survival(PFS)
Time Frame: up to 96 weeks
|
From the start of randomization to the first tumor progression or time of death.
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up to 96 weeks
|
Time to reach maximum (peak) plasma concentration following drug administration(Tmax)
Time Frame: Pre-dose, 30 minutes, 1, 2, 3, 4, 6, 8,12, 24, 48, 72, 96, 120,168 hours after oral administration of a single drug delivery; 30 minutes, 1, 2, 3, 4, 6, 8,12, 24 hours of day 28; 30 minutes before oral administration on day 8, day 15, day 22, day 28.
|
To characterize the pharmacokinetics of TQB3617 by assessment of time to reach maximum plasma concentration after single and multiple dosing
|
Pre-dose, 30 minutes, 1, 2, 3, 4, 6, 8,12, 24, 48, 72, 96, 120,168 hours after oral administration of a single drug delivery; 30 minutes, 1, 2, 3, 4, 6, 8,12, 24 hours of day 28; 30 minutes before oral administration on day 8, day 15, day 22, day 28.
|
Maximum (peak) plasma drug concentration (Cmax)
Time Frame: Pre-dose, 30 minutes, 1, 2, 3, 4, 6, 8,12, 24, 48, 72, 96, 120,168 hours after oral administration of a single drug delivery; 30 minutes, 1, 2, 3, 4, 6, 8,12, 24 hours of day 28; 30 minutes before oral administration on day 8, day 15, day 22, day 28.
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Cmax is the maximum plasma concentration of TQB3617 or metabolite(s).
|
Pre-dose, 30 minutes, 1, 2, 3, 4, 6, 8,12, 24, 48, 72, 96, 120,168 hours after oral administration of a single drug delivery; 30 minutes, 1, 2, 3, 4, 6, 8,12, 24 hours of day 28; 30 minutes before oral administration on day 8, day 15, day 22, day 28.
|
Elimination half-life (to be used in one-or non- compartmental model) (t1/2)
Time Frame: Pre-dose, 30 minutes, 1, 2, 3, 4, 6, 8,12, 24, 48, 72, 96, 120,168 hours, after oral administration of a single drug delivery.
|
t1/2 is time it takes for the blood concentration of TQB3617 or metabolite(s) to drop by half.
|
Pre-dose, 30 minutes, 1, 2, 3, 4, 6, 8,12, 24, 48, 72, 96, 120,168 hours, after oral administration of a single drug delivery.
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Maximum (peak) steady-state plasma drug concentration during a dosage interval (Cmax,ss)
Time Frame: Pre-dose, 30 minutes, 1, 2, 3, 4, 6, 8,12, 24, 48, 72, 96, 120,168 hours after oral administration of a single drug delivery; 30 minutes, 1, 2, 3, 4, 6, 8,12, 24 hours of day 28; 30 minutes before oral administration on day 8, day 15, day 22, day 28.
|
Maximum (peak) steady-state plasma drug concentration during a dosage interval
|
Pre-dose, 30 minutes, 1, 2, 3, 4, 6, 8,12, 24, 48, 72, 96, 120,168 hours after oral administration of a single drug delivery; 30 minutes, 1, 2, 3, 4, 6, 8,12, 24 hours of day 28; 30 minutes before oral administration on day 8, day 15, day 22, day 28.
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Minimum steady-state plasma drug concentration during a dosage interval (Css-min)
Time Frame: Pre-dose, 30 minutes, 1, 2, 3, 4, 6, 8,12, 24, 48, 72, 96, 120,168 hours after oral administration of a single drug delivery; 30 minutes, 1, 2, 3, 4, 6, 8,12, 24 hours of day 28; 30 minutes before oral administration on day 8, day 15, day 22, day 28.
|
Minimum steady-state plasma drug concentration during a dosage interval
|
Pre-dose, 30 minutes, 1, 2, 3, 4, 6, 8,12, 24, 48, 72, 96, 120,168 hours after oral administration of a single drug delivery; 30 minutes, 1, 2, 3, 4, 6, 8,12, 24 hours of day 28; 30 minutes before oral administration on day 8, day 15, day 22, day 28.
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Concentration at the end of the dosing interval AUCtau,ss
Time Frame: Pre-dose, 30 minutes, 1, 2, 3, 4, 6, 8,12, 24, 48, 72, 96, 120,168 hours after oral administration of a single drug delivery; 30 minutes, 1, 2, 3, 4, 6, 8,12, 24 hours of day 28; 30 minutes before oral administration on day 8, day 15, day 22, day 28.
|
To characterize the pharmacokinetics of TQB3617 by assessment of area the concentration at the end of the administration interval
|
Pre-dose, 30 minutes, 1, 2, 3, 4, 6, 8,12, 24, 48, 72, 96, 120,168 hours after oral administration of a single drug delivery; 30 minutes, 1, 2, 3, 4, 6, 8,12, 24 hours of day 28; 30 minutes before oral administration on day 8, day 15, day 22, day 28.
|
Overall Survival(OS)
Time Frame: assessed up to 100 months
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From date of first administration of test drug until the date of death from any cause,
|
assessed up to 100 months
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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 (ACTUAL)
January 5, 2022
Primary Completion (ANTICIPATED)
October 1, 2022
Study Completion (ANTICIPATED)
December 1, 2022
Study Registration Dates
First Submitted
November 4, 2021
First Submitted That Met QC Criteria
November 4, 2021
First Posted (ACTUAL)
November 8, 2021
Study Record Updates
Last Update Posted (ACTUAL)
February 14, 2022
Last Update Submitted That Met QC Criteria
February 11, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TQB3617-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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