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

Launched by CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD. · May 14, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called TQB3117, which is in tablet form, for patients with advanced malignant cancer. The main goal of the trial is to assess how safe the medication is, how well patients can tolerate it, and how the body processes it. The trial is split into two parts: one where the dose of the medication is gradually increased to find the best level, and the other where the selected dose will be given to patients for a longer period. The study will take place at one location and is open to both men and women aged 18 to 75 who have been diagnosed with advanced cancer and have at least one measurable tumor.

To participate, candidates must be in relatively good health and not have any serious health issues that could interfere with the study. They should also not have had other cancers in the past three years or major surgeries recently. Patients will need to provide consent to join the study, and women must take steps to avoid pregnancy during the trial. Those who meet the eligibility criteria will be closely monitored throughout the study to ensure their safety and gather important information about the medication's effects.

Gender

ALL

Eligibility criteria

• 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.