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

Overview

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.

Interventions

• Drug TQB3117 tablets
  TQB3117 is a protein inhibitor.

Primary outcome measures

• Dose Limiting Toxicity (DLT) [Time frame: At the end of Cycle 1 (each cycle is 21 days)]
• Maximum tolerated dose (MTD) [Time frame: At the end of Cycle 1 (each cycle is 21 days)]
• Recommended Phase II Dose (RP2D) [Time frame: Baseline up to 24 months]

Secondary outcome measures (10)

• Adverse events (AE) [Time frame: 30 days after the last administration]
• Serious adverse events (SAE) [Time frame: 30 days after the last administration]
• Time to reach maximum plasma concentration (Tmax) [Time frame: 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.]
• Peak concentration (Cmax) [Time frame: 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.]
• Half-life (t1/2) [Time frame: 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.]
• Area under the concentration-time curve (AUC [0-infinity] [Time frame: 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.]
• Area under the concentration-time curve (AUC [0-t] [Time frame: 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.]
• Apparent clearance (CL/F) [Time frame: 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.]
• Apparent volume of distribution (Vd/F) [Time frame: 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.]
• Objective Response Rate (ORR) [Time frame: From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• The First Affiliated Hospital of Shandong First Medical University — Jinan

Identifiers

NCT: NCT06415903 · TQB3117-I-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗