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NCT06332755RecruitingPhase 1

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)

Source: ClinicalTrials.gov · Last updated 24 Nov 2025

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
76 (estimated)
First submitted
16 Feb 2024
Start date
5 Jun 2024
Primary completion date
Nov 2027
Lead sponsor
LG Chem
NCT number
NCT06332755

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 76
  • From 5 Jun 2024 to the primary completion date, Nov 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participants with any concurrent active malignancies
  • Has received prior therapy targeting LILRB or immunoglobulin-like transcript pathway.
  • History of life-threatening toxicity related to prior immune therapy
  • Has not recovered to ≤ Grade 1 or baseline from AEs and/or complications from prior surgical intervention or any anti-cancer treatment before starting study treatment
  • Evidence of active infection requiring IV antibiotic treatment ≤7 days prior to initiation of study treatment therapy (does not apply to viral infections that are presumed to be associated with the underlying tumor type required for study entry).
  • (Phase 1b only) Participants who were previously exposed to atezolizumab

Other illness

  • Clinically significant cardiac disease or cardiac failure.
  • Untreated or unstable brain or central nervous system (CNS) metastases or Leptomeningeal disease
  • Participants must not have an active, known, or suspected autoimmune disease.
  • Any condition that would, in the Investigator's judgment, interfere with full participation in the study, including administration of study intervention and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.

Other

  • Pregnant or lactating or expecting to conceive a child during the study or within 6 months after the last dose of study intervention.

Who the study is looking for

  • Age ≥18 years old at the time of signing the ICF.
  • (Phase 1a only) Participants must have 1 of the following histologically confirmed advanced or metastatic solid tumors with measurable or non-measurable disease as determined by RECIST v1.1,
    • \- NSCLC, HNSCC, RCC, urothelial carcinoma, or malignant melanoma.
  • (Phase 1a only) Participants who have metastatic disease which has progressed during or after approved standard therapies or are intolerant to approved therapies, or for which the participant refuses or is ineligible for standard therapy.
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1.
  • Life expectancy ≥12 weeks.
  • Participants with adequate organ function
  • No potential for childbearing or agree to use adequate contraception
  • Ability to understand the study purpose and procedures and have the willingness to sign a written informed consent document.
  • (Phase 1b only ) Must have histologically confirmed advanced or metastatic NSCLC without actionable genomic alteration that have approved therapies in the location where the participant's live and with measurable disease as determined by RECIST v1.1

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
NEXT Oncology
Coordinator of this site? Confirm its status
FairfaxUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.