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

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChia Tai Tianqing Pharmaceutical Group Co., Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • TQB3117 tablets

Treatment groups

59 Participants
are divided into 1 treatment group