A First-in-Human, Phase 1/2 Study of LAT010 in Patients With Advanced

Status Recruiting

Clinical Trial Summary

This is an open-label, multicenter, Phase 1/2, first-in-human (FIH), dose-escalation and cohort-expansion study of LAT010 to evaluate the safety, tolerability, immunogenicity, PK, PD, and antitumor activity in patients with advanced solid tumors. The study consists of 2 parts: Phase 1 dose-escalation and Phase 2 cohort expansion.

Clinical Trial Description

Interleukin-2 (IL-2) agonists have shown significant antitumor activities but are associated with severe toxic side effects, due to prioritized activation of high-affinity IL-2 receptor (i.e., IL2Rαβγ). LAT010 is a human IL-2 based immunocytokine designed to exclusively interact with intermediate-affinity IL-2 receptor (i.e., IL2Rβγ) but not the high-affinity IL2Rαβγ receptor. Its exceptional selectivity in activating CD8+ T cells and NK cells may confer the clinical benefits of IL-2 in promoting antitumor immunity without the associated safety concerns. Phase 1 of the study will examine LAT010 in an accelerated and standard "3+3" dose-escalation design. It consists of 7 planned cohorts. Approximately 20 to 50 patients with locally advanced or metastatic solid tumors will be enrolled in the cohorts. Each treatment cycle consists of 4 weeks, during which patients will receive an IV injection of LAT010 at the assigned dose once weekly. The DLT observation period is the first treatment cycle (28 days). Phase 2 will be initiated after the MTD or a RP2D has been determined in Phase 1. Approximately up to 30 patients per cohort by tumor type will be enrolled to further evaluate the safety and efficacy of LAT010 in the treatment of selected tumor types at multiple dose levels based on the results of Phase 1. The primary objective of Phase 2 study is to define the preliminary efficacy in the setting of advanced cancers with high unmet medical needs. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06277219
Study type	Interventional
Source	Latticon Antibody Therapeutics, Inc
Contact	Lightspeed Study Contact
Phone	412-401-3699
Email	lightspeed-1@latticon.com
Status	Recruiting
Phase	Phase 1/Phase 2
Start date	June 2024
Completion date	March 2027

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

A First-in-Human, Phase 1/2 Study of LAT010 in Patients With Advanced Solid Tumors (LIGHTSPEED-1) — LIGHTSPEED-1

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms