Advanced Malignant Tumors
Conditions
Brief summary
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.
Interventions
DRUGTQB3617
TQB3617 is a BET inhibitor.
Sponsors
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum tolerated dose (MTD) | Baseline up to 48 weeks | The highest dose of a drug or treatment that does not cause unacceptable side effects. |
| Adverse events (AEs) and serious adverse events (SAEs) | Baseline up to 48 weeks | The occurrence of all AEs and SAEs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Elimination half-life (to be used in one-or non- compartmental model) （t1/2） | 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. |
| Maximum (peak) steady-state plasma drug concentration during a dosage interval （Cmax,ss） | 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 |
| Overall response rate (ORR) | up to 96 weeks | Percentage of participants achieving complete response (CR) and partial response (PR). |
| Minimum steady-state plasma drug concentration during a dosage interval （Css-min） | 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 |
| Time to reach maximum (peak) plasma concentration following drug administration（Tmax） | 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 |
| Progress Free Survival（PFS） | up to 96 weeks | From the start of randomization to the first tumor progression or time of death. |
| Disease control rate（DCR） | up to 96 weeks | Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD). |
| Duration of Response (DOR) | up to 96 weeks | The time when the participants first achieved complete or partial remission to disease progression. |
| Overall Survival（OS） | assessed up to 100 months | From date of first administration of test drug until the date of death from any cause， |
| Concentration at the end of the dosing interval AUCtau,ss | 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 |
| Maximum (peak) plasma drug concentration （Cmax） | 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. | Cmax is the maximum plasma concentration of TQB3617 or metabolite(s). |
Countries
China
Contacts
Primary ContactXiaojia Wang, Master
Outcome results
None listed