NCT06752447

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

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

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 94 (estimated)
• Sponsor: Shandong New Time Pharmaceutical Co., LTD · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Detailed description

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. This study is divided into dose escalation stage and dose extension stage. A total of 9 dose groups were designed in the dose escalation phase. The dose expansion phase is planned to be conducted in two dose groups (determined by discussion between the investigator and sponsor based on available trial data), enrolling approximately 20 participants at each dose. According to the results of dose escalation phase, the pre-excitation dose of dose extension phase is designed.

Conditions

• Advanced Solid Tumors (Phase 1)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-01-20
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2024-12-30
• Last updated: 2024-12-30