A Clinical Study to Evaluate the Tolerability and Pharmacokinetics of TQB3617 Capsule in Patients With Advanced Malignant Tumors

Advanced Malignant Tumors Clinical Trial

Official title:

Phase I Clinical Study to Evaluate the Tolerability and Pharmacokinetics of TQB3617 Capsule in Patients With Advanced Malignant Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05110807
• Other study ID #: TQB3617-I-01
• Status: Recruiting
• Phase: Phase 1
• Start date: January 5, 2022
• Est. completion date: December 2022

Study information

• Verified date: February 2022
• Source: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Contact: Xiaojia Wang, Master
• Phone: 0571-88122146
• Email: huang_jian22[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 38
• Est. completion date: December 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Malignant Tumors
• Neoplasms

Intervention

Drug:
• TQB3617
TQB3617 is a BET inhibitor.

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Cen	Guangzhou	Guangdong
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose (MTD)	The highest dose of a drug or treatment that does not cause unacceptable side effects.	Baseline up to 48 weeks
Primary	Adverse events (AEs) and serious adverse events (SAEs)	The occurrence of all AEs and SAEs	Baseline up to 48 weeks
Secondary	Time to reach maximum (peak) plasma concentration following drug administration(Tmax)	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.
Secondary	Maximum (peak) plasma drug concentration (Cmax)	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.
Secondary	Elimination half-life (to be used in one-or non- compartmental model) (t1/2)	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.
Secondary	Maximum (peak) steady-state plasma drug concentration during a dosage interval (Cmax,ss)	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.
Secondary	Minimum steady-state plasma drug concentration during a dosage interval (Css-min)	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.
Secondary	Concentration at the end of the dosing interval AUCtau,ss	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.
Secondary	Overall response rate (ORR)	Percentage of participants achieving complete response (CR) and partial response (PR).	up to 96 weeks
Secondary	Progress Free Survival(PFS)	From the start of randomization to the first tumor progression or time of death.	up to 96 weeks
Secondary	Disease control rate(DCR)	Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).	up to 96 weeks
Secondary	Duration of Response (DOR)	The time when the participants first achieved complete or partial remission to disease progression.	up to 96 weeks
Secondary	Overall Survival(OS)	From date of first administration of test drug until the date of death from any cause,	assessed up to 100 months