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

NCT05110807 | Unknown Phase 1

• 1 other identifier: TQB3617-I-01
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 2

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.

Conditions

Advanced Malignant Tumors

Outcome Measures

Primary Outcomes (2)

• Maximum tolerated dose (MTD)

  The highest dose of a drug or treatment that does not cause unacceptable side effects.

  Baseline up to 48 weeks

• Adverse events (AEs) and serious adverse events (SAEs)

  The occurrence of all AEs and SAEs

  Baseline up to 48 weeks

Secondary Outcomes (11)

• 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.

• 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.

• 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.

• 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.

• 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.

Study Arms (1)

TQB3617

EXPERIMENTAL

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.

Drug: TQB3617

Interventions

TQB3617 DRUG

TQB3617 is a BET inhibitor.

TQB3617

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (2)

Sun Yat-sen University Cancer Cen

Guangzhou, Guangdong, 510060, China

RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 31002, China

RECRUITING

Related Publications (1)

• Zhang Y, Yin Q, Zhao B, Liu F, Li S, Cai J, Fang X, Bai B, Nie M, Zou Q, Ding D, Wang X, Zhu J, Yu D, Wang X, Zhang X, Wang L, Xia Y, Cai Q. TQB3617, a bromodomain and extra-terminal inhibitor, in patients with relapsed or refractory lymphoma: A multicenter, phase 1 trial. Med. 2026 Jan 9;7(1):100893. doi: 10.1016/j.medj.2025.100893. Epub 2025 Oct 27.

  PMID: 41151587 DERIVED

Central Study Contacts

Xiaojia Wang, Master

CONTACT

0571-88122146; huang_jian22@aliyun.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2021
• First Posted: November 8, 2021
• Study Start: January 5, 2022
• Primary Completion: October 1, 2022
• Study Completion: December 1, 2022
• Last Updated: February 14, 2022

Record last verified: 2022-02

Locations

CN (2)