RecruitingPhase 1NCT06332755

Study to Evaluate LB-LR1109, Administered Alone for the Treatment of Solid Tumor and in Combination With Atezolizumab for the Treatment of NSCLC

A Phase 1a/1b, First-in-Human, Open-Label, Multi-Center, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LB-LR1109, When Administered Alone for the Treatment of Advanced or Metastatic Solid Tumors, and in Combination With Atezolizumab for the Treatment of Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)


Sponsor

LG Chem

Enrollment

76 participants

Start Date

Jun 5, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a Phase 1a/1b, first-in-human (FIH), multi-center, open-label, non-randomized, dose escalation study, designed to determine the Maximum tolerated dose(MTD)/Recommended Phase 2 dose (RP2D) and to evaluate safety, tolerability, preliminary efficacy, pharmacokinetics, immunogenicity, pharmacodynamics of LB-LR1109 as monotherapy in participants with advanced and/or metastatic non small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), renal cell carcinoma (RCC), urothelial carcinoma, or malignant melanoma and no available standard of care treatment options, and as combination therapy with atezolizumab in participants with advanced and/or metastatic NSCLC.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new cancer drug called LB-LR1109, which targets a protein on immune cells called LILRB (a receptor that can suppress the immune system's ability to fight cancer). In one part of the study it is tested alone in various solid tumors; in another part it is combined with atezolizumab (a standard immunotherapy drug) specifically in non-small cell lung cancer. Researchers want to find the right dose and see whether the drug is safe and effective. **You may be eligible if:** - You are 18 or older with confirmed advanced or metastatic solid cancer (Phase 1a: NSCLC, head and neck cancer, kidney cancer, bladder cancer, or melanoma) - Your cancer has progressed on or you are intolerant of standard therapies - You are in good physical condition (ECOG 0 or 1) with a life expectancy of at least 12 weeks - For Phase 1b: you have advanced NSCLC without targetable gene mutations and have measurable disease **You may NOT be eligible if:** - You have significant heart disease or heart failure - You have untreated or unstable brain metastases - You have another active cancer at the same time - You have previously received a therapy targeting LILRB Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPhase 1a: LB-LR1109

intravenous administration

DRUGPhase 1b: LB-LR1109 and Atezolizumab

intravenous administration


Locations(1)

NEXT Oncology

Fairfax, Virginia, United States

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NCT06332755


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