Clinical trial NCT05110807: A Clinical Study to Evaluate the Tolerability and Pharmacokinetics of TQB3617 Capsule in Patients With Advanced Malignant Tumors
Official title: Phase I Clinical Study to Evaluate the Tolerability and Pharmacokinetics of TQB3617 Capsule in Patients With Advanced Malignant Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Advanced Malignant Tumors
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-11-08
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Maximum tolerated dose (MTD)
timeFrame: Baseline up to 48 weeks
measure: Adverse events (AEs) and serious adverse events (SAEs)
timeFrame: Baseline up to 48 weeks
Secondary outcomes:
measure: Time to reach maximum (peak) plasma concentration following drug administration（Tmax）
timeFrame: 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.
measure: Maximum (peak) plasma drug concentration （Cmax）
timeFrame: 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.
measure: Elimination half-life (to be used in one-or non- compartmental model) （t1/2）
timeFrame: 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.
measure: Maximum (peak) steady-state plasma drug concentration during a dosage interval （Cmax,ss）
timeFrame: 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.
measure: Minimum steady-state plasma drug concentration during a dosage interval （Css-min）
timeFrame: 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.
measure: Concentration at the end of the dosing interval AUCtau,ss
timeFrame: 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.
measure: Overall response rate (ORR)
timeFrame: up to 96 weeks
measure: Progress Free Survival（PFS）
timeFrame: up to 96 weeks
measure: Disease control rate（DCR）
timeFrame: up to 96 weeks
measure: Duration of Response (DOR)
timeFrame: up to 96 weeks
measure: Overall Survival（OS）
timeFrame: assessed up to 100 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Cen
state: Guangdong
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
References: