Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06332755

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

Led by LG Chem · Updated on 2025-11-24

76

Participants Needed

1

Research Sites

195 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older at time of consent
  • (Phase 1a) Histologically confirmed advanced or metastatic NSCLC, HNSCC, RCC, urothelial carcinoma, or malignant melanoma with measurable or non-measurable disease
  • (Phase 1a) Disease progressed after or intolerant to approved therapies, or participant refuses or is ineligible for standard therapy
  • ECOG Performance Status 0 or 1
  • Life expectancy of at least 12 weeks
  • Adequate organ function
  • No potential for childbearing or agreement to use adequate contraception
  • Ability to understand study purpose and willingness to sign informed consent
  • (Phase 1b) Histologically confirmed advanced or metastatic NSCLC without actionable genomic alterations with measurable disease
Not Eligible

You will not qualify if you...

  • Clinically significant cardiac disease or cardiac failure
  • Untreated or unstable brain or CNS metastases or leptomeningeal disease
  • Any concurrent active malignancies
  • Prior therapy targeting LILRB or immunoglobulin-like transcript pathway
  • History of life-threatening toxicity related to prior immune therapy
  • Not recovered to Grade 1 or baseline from adverse events or complications from prior cancer treatments
  • Active, known, or suspected autoimmune disease
  • Active infection requiring intravenous antibiotics within 7 days before study treatment (except viral infections related to underlying tumor)
  • Pregnant, lactating, or planning pregnancy during study or within 6 months after last dose
  • Any condition interfering with study participation or posing significant risk
  • (Phase 1b) Prior exposure to atezolizumab

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

NEXT Oncology

Fairfax, Virginia, United States, 22031

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

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