A Clinical Trial of TQB3117 Tablets in Patients With Advanced Malignant Cancer

CTTQ

Status and phase: Not yet enrolling; Phase 1

Conditions: Advanced Malignant Cancer

Treatments: Drug: TQB3117 tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT06415903

TQB3117-I-01

Details and patient eligibility

About

The study is divided into two phases: dose escalation and dose extension. The dosing regimens include a single-dose study and a multiple-dose study. It adopts a single-center, open-label, non-randomized, single-arm clinical trial design, where patients with advanced malignant cancer are selected to orally take TQB3117 tablets. The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of TQB3117 tablets in patients.

Enrollment: 59 estimated 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 criteria;
• The main organs function well;
• Female patient had no plans to become pregnant and voluntarily took effective contraceptive measures from agree with the study to at least 6 months after the last dose of study drug.

Exclusion criteria

• There were other malignant tumors in 3 years;
• Has multiple factors affecting oral medication;
• Unalleviated toxicity ≥ grade 1 above 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 included: active hepatitis, have a history of immunodeficiency;
• Has known symptomatic central nervous system metastases and/or cancerous meningitis;
• Thoracic/abdominal/pericardial effusion with clinical symptoms or requiring repeated drainage, or drainage for the purpose of receiving treatment within one month after receiving the investigational drug for the first time;
• 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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59 participants in 1 patient group

TQB3117 tablets

Experimental group

Description:

TQB3117 tables is administered as a single dose or multiple dose, ranging from 20 to 180 mg once daily. Oral administration on fast condition, with each cycle lasting 21 days.

Treatment:

Drug: TQB3117 tablets