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

CTTQ

Status and phase: Unknown; Phase 1

Conditions: Solid Tumor

Treatments: Drug: TQB3811

Study type: Interventional

Funder types: Industry

Identifiers

NCT05046847

TQB3811-I-01

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

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.
• 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.
• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

30 participants in 1 patient group

TQB3811

Experimental group

Description:

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.

Treatment:

Drug: TQB3811