A Clinical Study to Evaluate the Tolerability and Pharmacokinetics of TQB3811 Tablets in Patients With Advanced Malignant Tumors

NCT05046847 | Unknown Phase 1

• 1 other identifier: TQB3811-I-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

TQB3811 tablet is a second-generation tropomyosin receptor kinase (TRK) inhibitor that selectively inhibits the kinase activity of TRKA, TRKB, and TRKC, and also selectively inhibits the kinase activity of TRKA, TRKB, and TRKC that produce secondary drug-resistant mutations.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (3)

• Maximum tolerated dose (MTD)

  To evaluate MTD of TQB3811 tablets in Chinese adult patients with advanced solid tumors

  Baseline up to 32 weeks

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

  The occurrence of all AEs and SAEs

  Baseline up to 28 days

• Dose-limiting toxicity (DLT)

  To evaluate DLT of TQB3811 tablets in Chinese adult patients with advanced solid tumors

  Baseline up to 32 weeks

Secondary Outcomes (10)

• Time to reach maximum (peak) plasma concentration following drug administration（Tmax）

  15, 30minutes, 1, 2, 4, 6, 8,10, 24, 48 hours after oral administration of day 1 and day 11;30 minutes before oral administration on day 1, day5, day7,day8 ,day 9 and day11.

• Maximum (peak) plasma drug concentration （Cmax）

  15, 30 minutes, 1, 2, 4, 6, 8,10, 24, 48 hours after oral administration of day 1 ;30 minutes before oral administration on day 1.

• Elimination half-life （t1/2）

  15, 30minutes, 1, 2, 4, 6, 8,10, 24, 48 hours after oral administration of day 1 and day 11;30 minutes before oral administration on day 1, day5, day7,day8 ,day 9 and day11.

• Area under the plasma concentration-time curve from time zero to time t （AUC0-t）

  15, 30 minutes, 1, 2, 4, 6, 8,10, 24, 48 hours after oral administration of day 1 ;30 minutes before oral administration on day 1.

• Maximum (peak) steady-state plasma drug concentration during a dosage interval （Cmax,ss）

  15, 30 minutes, 1, 2, 4, 6, 8,10, 24, 48 hours after oral administration of day 1 and day 11;30 minutes before oral administration on day 1, day5, day7,day8 ,day 9 and day11.

Study Arms (1)

TQB3811

EXPERIMENTAL

The initial dose is 2.5mg, once a day (QD), and the medication stage is divided into single administration and continuous administration. The single administration is given once a day, and the continuous administration is entered 4 days after drug withdrawal. The drug is administered continuously until the disease progresses.

Drug: TQB3811

Interventions

TQB3811 DRUG

TQB3811 is a second-generation TrkA inhibitor.

TQB3811

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with advanced malignancy diagnosed histologically and/or cytologically, who have failed standard treatment or are unable to receive standard treatment or have no effective treatment.
• Age: 18\~75 years old.
• Women of childbearing age must be negative for serum or urine HCG within 7 days prior to study enrollment and must be non-lactating; Patients should agree to use contraception during the study period and for 6 months after the study period.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months.
• Patients voluntarily joined the study and signed the informed consent, showing good compliance.

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.
• The patient had experienced an arterial/venous thrombosis event in the past 6 months, such as a cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis, and pulmonary embolism.
• The patient has a history of psychotropic drug abuse and cannot quit or has mental disorders.
• Patients are taking cytochrome P450 3A (CYP3A) inhibitors or inducers.
• Patients have uncontrolled pleural effusion, pericardial effusion, or ascites that still require repeated drainage.
• Patients with brain metastases with symptoms or control of symptoms for less than 2 weeks.
• The patients were currently breastfeeding or planned to breastfeed during the study period.

Sponsors & Collaborators

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

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

Central Study Contacts

LIN SHEN, Master

CONTACT

010-88196561; doctorshenlin@sina.cn

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: September 13, 2021
• First Posted: September 16, 2021
• Study Start: November 30, 2021
• Primary Completion: October 1, 2022
• Study Completion: December 1, 2022
• Last Updated: December 3, 2021

Record last verified: 2021-12

Locations

CN (1)