NCT06277219

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

A Phase 1/2, Dose-Escalation and Cohort-Expansion Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Efficacy of LAT010 in Patients With Advanced Solid Tumors (LIGHTSPEED-1)

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Latticon Antibody Therapeutics, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	LAT010	LAT010 monotherapy
DRUG	LAT010 + ICI	LAT010 combination with PD-1 inhibitor

Timeline

• Start date: 2024-06-05
• Primary completion: 2026-12-01
• Completion: 2027-03-01
• First posted: 2024-02-26
• Last updated: 2025-07-08

Locations

4 sites across 2 countries: United States, China

Regulatory

• FDA-regulated drug study