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NOT YET RECRUITING
NCT06752447
PHASE1

A Phase I Study OfLNF2007 Monotherapy in Patients with Advanced Solid Tumors

Sponsor: Shandong New Time Pharmaceutical Co., LTD

View on ClinicalTrials.gov

Summary

A non-randomized, open-ended, phase I dose-escalation and dose-expansion study was designed to evaluate the safety, tolerability, antitumor efficacy, PK and immunogenic characteristics of LNF2007 in patients with advanced solid tumors

Official title: A Phase I Clinical Study of Safety, Tolerability, Pharmacokinetic/pharmacodynamic Characteristics and Initial Efficacy of LNF2007 Monotherapy in Patients with Advanced Solid Tumors

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

94

Start Date

2025-01-20

Completion Date

2026-12

Last Updated

2024-12-30

Healthy Volunteers

No

Interventions

DRUG

LNF2007

LNF2007,9 dose groups:0.2μg/kg、1μg/kg、5μg/kg、20μg/kg、60μg/kg、120μg/kg、240μg/kg、360μg/kg、540μg/kg(0.2\~5μg/kg for "accelerated titration", and i3+3 ramp-up starting from 20μg/kg dose group),IV, infusion time 60min±10min, Q4W, until disease progression 、intolerable toxicity or other reasons to stop treatment, the longest administration to 2 years, whichever occurs first.