A Clinical Trial of TQB3006 Tablets in Patients With Advanced Malignant Cancer

CTTQ

Status and phase: Completed; Phase 1

Conditions: Advanced Malignant Neoplasm

Treatments: Drug: TQB3006 tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT06344351

TQB3006-I-01

Details and patient eligibility

About

This study includes two stage: dose escalation and dose extension, with a single dose and a multiple dose study. This is a single-center, open, non-randomized, single arm, study to evaluate the safety, tolerability and pharmacokinetics of TQB3006 tables in patients with advanced malignant cancer.

Enrollment: 27 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study;
• Age: 18 to 75 years old; an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
• Has at least one assessable lesion according to Response Evaluation Criteria In Solid Tumors (RECIST) v1.1;
• Female patient had no plans to become pregnant and voluntarily took effective contraceptive measures during the study period to at least 6 months after the last dose of study drug.

Exclusion criteria

• There were other malignant tumors within 3 years;

• Has multiple factors affecting oral medication;

• Unalleviated toxicity ≥ grade 1 of CTCAE v5.0 due to any previous therapy , excluding hair loss;

• Major surgical treatment, open biopsy and obvious traumatic injury were performed within 28 days before the study，or have not fully recovered from previous surgery, or are expected to require major surgical surgery during the study period;

• Arteriovenous thrombotic events occurred within 6 months, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism;

• Have a history of psychotropic drug abuse and can not quit or have mental disorders;

• Subjects with any severe and / or uncontrolled disease including active hepatitis, a history of immunodeficiency, etc.;

• Tumor-related symptoms and treatment:

  1. Has known symptomatic central nervous system metastases and/or cancerous meningitis;
  2. Thoracic/abdominal/pericardial effusion with clinical symptoms or requiring repeated drainage, or drainage for the purpose of receiving treatment within 1 month after receiving the investigational drug for the first time;
  3. Has participated in other clinical trials within 4 weeks before first dose.

• According to the judgement of the investigators, there are other factors that may lead to the termination of the study.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

TQB3006 tablets

Experimental group

Description:

TQB3006 tables is administered as a single dose or multiple dose .Take200-1200 mg per day; Take TQB3006 orally on an empty stomach once or twice a day, 21 days as a cycle.

Treatment:

Drug: TQB3006 tablets