A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of TFX05-01 in Participants With Advanced Malignancies

Shenzhen Yangli Pharmaceutical Technology Co., Ltd4 sites in 1 country36 target enrollmentJune 5, 2022

ConditionsAdvanced Solid Tumor

InterventionsTFX05-01

DrugsTFX05-01

Overview

Phase: Phase 1
Intervention: TFX05-01
Conditions: Advanced Solid Tumor
Sponsor: Shenzhen Yangli Pharmaceutical Technology Co., Ltd
Enrollment: 36
Locations: 4
Primary Endpoint: Incidence of Treatment-Emergent Adverse Events (AE) [Safety and Tolerability]
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is an open-label, non-randomized, multicenter, Phase Ⅰ/Ⅱa study to evaluate the safety, tolerability, pharmacokinetics and efficacy of TFX05-01 in patients with advanced solid tumors.

Detailed Description

The study to evaluate the safety, tolerability, pharmacokinetics and efficacy of TFX05-01 in patients with advanced solid tumors, which was divided into dose exploration part (Phase Ⅰ) and indication exploration part (Phase Ⅱa). Each Phase of the study consisted of a screening period (21 days before initial dosing), a treatment period (from the first trial to the onset of an endpoint event), and a follow-up period.

Registry

clinicaltrials.gov

Start Date

June 5, 2022

End Date

December 2025

Last Updated

3 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Shenzhen Yangli Pharmaceutical Technology Co., Ltd

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female participants ≥ 18 years of age at the time of screening. And participants ≤75 years of age for phase Ⅰ.
•All toxicities from prior therapy (except for alopecia, fatigue, or peripheral neuropathy) must have returned to grade 0 or 1 (NCI CTCAE 5th edition) before initiation of the study drug.
•Subjects with advanced malignant solid tumors confirmed by histopathology/cytology or clinical diagnosis, who are not suitable for surgery or local therapy, or whose disease has progressed after surgery and/or last-line standard therapy and/or cannot tolerate standard therapy.
•Subjects have at least one measurable lesion that meets RECIST 1.1 criteria. Lesions previously irradiated are not considered measurable lesions unless they show clear radiographic progression after radiotherapy.
•Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or
•Life expectancy ≥ 12 weeks.
•The cardiac QTcF interval is ≤ 450 ms in males and ≤ 470 ms in females.
•Laboratory tests must meet the following criteria:
•Hematologic function (no blood transfusion or cell growth factor correction within 14 days before screening): hemoglobin ≥ 90 g/L, platelet count ≥ 100 × 10\^9/L, absolute neutrophil count (ANC) ≥1.5 × 10\^9/L;
•Hepatic and renal function (no albumin infusion within 14 days before screening): creatinine clearance \>60 mL/min measured by Cockcroft-Gault equation. Serum total bilirubin ≤2.5 times the upper limit of normal (ULN); ALT and AST≤2.5 × ULN (AST and ALT ≤5×ULN for patients with comorbidities liver metastases);

Exclusion Criteria

•Untreated active central nervous system (CNS) metastases, brain metastases, or leptomeningeal disease. Subjects may participate in the study if their CNS metastases had been adequately treated and were stable for at least 4 weeks as confirmed by clinical examination and brain imaging (MRI or CT) during screening.
•More than 25% of the bone marrow had previously received radiotherapy.
•Have a history of severe allergies in the past, or are allergic to any active or inactive ingredients (phosphates, etc.) of the study drug.
•Major surgery other than diagnostic surgery within 4 weeks before the first dose of the study drug.
•Subjects who received radiation therapy, surgery, chemotherapy, immunotherapy, biological therapy for cancer, targeted therapy, or hormonal therapy within 4 weeks before the first dose of the study drug (exceptions: nitrosourea or mitomycin C therapy needs a 6-week washout period; oral fluorouracil, requiring a 2-week washout period; small molecule targeted therapy demands a 2-week washout period).
•Bleeding tendency and history of thrombosis: (1) Clinically significant bleeding symptoms or clear bleeding tendency within 3 months before screening; (2) History of gastrointestinal bleeding or clear gastrointestinal bleeding tendency within 6 months before screening; (3) Arterial/venous thrombotic events, such as cerebrovascular accident (including transient ischemic attack), within 6 months before screening.
•History of severe cardiovascular disease : (1) NYHA (New York Heart Association) grade 3 and 4 congestive heart failure; (2) unstable angina or newly diagnosed angina or myocardial infarction within 12 months before screening; (3) CTCAE ≥ grade 2 valvular heart disease; (4) hypertension (systolic blood pressure\>150mmHg or diastolic blood pressure\>90mmHg) poorly controlled by drugs.
•Subjects have any active, known, or suspected autoimmune disease.
•Clinically significant ascites, defined as detected by physical examination and requiring control by abdominocentesis, or increased medical intervention to maintain symptoms (patients with ascites detected only by imaging were eligible).
•Participated in a drug study (diagnostic or therapeutic) or device study within 4 weeks before the first dose of the study drug.

Arms & Interventions

Dose escalation

Single agent dose escalation

Intervention: TFX05-01

Dose expansion

Single agent dose expansion

Intervention: TFX05-01