Clinical trial NCT06344351: A Clinical Trial of TQB3006 Tablets in Patients With Advanced Malignant Cancer
Official title: A Phase I Study to Evaluate the Safety, Tolerance and Pharmacokinetics of TQB3006 Tablets in Patients With Advanced Malignant Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Malignant Neoplasm
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-04-03
Enrollment: 27
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: 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.


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;
* 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.

Primary outcomes:
measure: Dose limiting toxicity (DLT)
timeFrame: At the end of Cycle 1 (21 Days).
measure: Maximum tolerated dose (MTD)
timeFrame: At the end of Cycle 1 (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 dose.
measure: Serious adverse events (SAE)
timeFrame: 30 days after the last dose.
measure: Time to reach maximum plasma concentration (Tmax)
timeFrame: Day 1: pre-dose, at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 hours after-dose. Cycle 1 Day 1,Cycle 1 Day 7,Cycle 1 Day 14, Cycle 1 Day 21: pre-dose, Cycle 1 Day 21: at 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours after-dose. Each cycle is 21 days.
measure: Peak concentration (Cmax)
timeFrame: Day 1: pre-dose, at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 hours after-dose. Cycle 1 Day 1,Cycle 1 Day 7,Cycle 1 Day 14, Cycle 1 Day 21: pre-dose, Cycle 1 Day 21: at 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours after-dose. Each cycle is 21 days.
measure: Half-life (t1/2)
timeFrame: Day 1: pre-dose, at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 hours after-dose. Cycle 1 Day 1,Cycle 1 Day 7,Cycle 1 Day 14, Cycle 1 Day 21: pre-dose, Cycle 1 Day 21: at 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours after-dose. Each cycle is 21 days.
measure: Area under the concentration-time curve (AUC [0-infinity])
timeFrame: Day 1: pre-dose, at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 hours after-dose. Cycle 1 Day 1,Cycle 1 Day 7,Cycle 1 Day 14, Cycle 1 Day 21: pre-dose, Cycle 1 Day 21: at 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours after-dose. Each cycle is 21 days.
measure: Area under the concentration-time curve (AUC [0-t])
timeFrame: Day 1: pre-dose, at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 hours after-dose. Cycle 1 Day 1,Cycle 1 Day 7,Cycle 1 Day 14, Cycle 1 Day 21: pre-dose, Cycle 1 Day 21: at 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours after-dose. Each cycle is 21 days.
measure: Apparent clearance (CL/F)
timeFrame: Day 1: pre-dose, at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 hours after-dose. Cycle 1 Day 1,Cycle 1 Day 7,Cycle 1 Day 14, Cycle 1 Day 21: pre-dose, Cycle 1 Day 21: at 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours after-dose. Each cycle is 21 days.
measure: Apparent volume of distribution (Vd/F)
timeFrame: Day 1: pre-dose, at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 hours after-dose. Cycle 1 Day 1,Cycle 1 Day 7,Cycle 1 Day 14, Cycle 1 Day 21: pre-dose, Cycle 1 Day 21: at 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours after-dose. Each cycle is 21 days.
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 100 weeks
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Provincial Hospital
state: Anhui
city: Beijing
country: China
facility: Peking University Shougang Hospital
state: Beijing
city: Chongqing
country: China
facility: Chongqing university Cancer Hospital
state: Chongqing
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Zhengzhou
country: China
facility: The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
state: Henan
Study officials:
References: