Clinical trial NCT06415903: A Clinical Trial of TQB3117 Tablets in Patients With Advanced Malignant Cancer
Official title: A Phase I Study to Evaluate the Safety and Tolerance of TQB3117 Tablets in Patients With Advanced Malignant Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Advanced Malignant Cancer
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-05-16
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Primary outcomes:
measure: Dose Limiting Toxicity (DLT)
timeFrame: At the end of Cycle 1 (each cycle is 21 days)
measure: Maximum tolerated dose (MTD)
timeFrame: At the end of Cycle 1 (each cycle is 21 days)
measure: Recommended Phase II Dose (RP2D)
timeFrame: Baseline up to 24 months
Secondary outcomes:
measure: Adverse events (AE)
timeFrame: 30 days after the last administration
measure: Serious adverse events (SAE)
timeFrame: 30 days after the last administration
measure: Time to reach maximum plasma concentration (Tmax)
timeFrame: Day 1 of single dose: pre-dose, at 0.5,1, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours after-dose. Days 7,14 and 21 of cycle1: pre-dose. Day 21of cycle1: at 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours after-dose.
measure: Peak concentration (Cmax)
timeFrame: Day 1 of single dose: pre-dose, at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours after-dose. Days 7,14 and 21 of cycle1: pre-dose. Day 21 of cycle 1: at 0.5,1, 2, 3, 4, 6, 8, 12, 24 hours after-dose.
measure: Half-life (t1/2)
timeFrame: Day 1 of single dose: pre-dose, at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours after-dose. Days 7, 14 and 21 of cycle 1: pre-dose. Day 21 of cycle 1: at 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours after-dose.
measure: Area under the concentration-time curve (AUC [0-infinity]
timeFrame: Day 1 of single dose: pre-dose, at 0.5,1, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours after-dose. Days 7, 14 and 21 of cycle 1: pre-dose, Day 21 of cycle 1: at 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours after-dose.
measure: Area under the concentration-time curve (AUC [0-t]
timeFrame: Day 1 of single dose: pre-dose, at 0.5,1, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours after-dose. Days 7, 14 and 21 of cycle 1: pre-dose. Day 21 of cycle 1: at 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours after-dose.
measure: Apparent clearance (CL/F)
timeFrame: Day 1 of single dose: pre-dose, at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours after-dose. Days 7, 14 and 21 of cycle 1: pre-dose. Day 21 of cycle 1: at 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours after-dose.
measure: Apparent volume of distribution (Vd/F)
timeFrame: Day 1 of single dose: pre-dose, at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours after-dose. Days 7, 14 and 21 of cycle 1: pre-dose. Day 21 of cycle 1: at 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours after-dose.
measure: Objective Response Rate (ORR)
timeFrame: From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100weeks
Other outcomes:
Locations:
city: Jinan
country: China
facility: The First Affiliated Hospital of Shandong First Medical University
state: Shandong
Study officials:
References: