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NCT Number: NCT06332755

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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

Key Exclusion Criteria:

  • Clinically significant cardiac disease or cardiac failure.
  • Untreated or unstable brain or central nervous system (CNS) metastases or Leptomeningeal disease
  • 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
  • Participants must not have an active, known, or suspected autoimmune disease.
  • 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).
  • Pregnant or lactating or expecting to conceive a child during the study or within 6 months after the last dose of study intervention.
  • 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.
  • (Phase 1b only) Participants who were previously exposed to atezolizumab

Treatment and study plan

Phase 1a: LB-LR1109

Drug

intravenous administration

Phase 1b: LB-LR1109 and Atezolizumab

Drug

intravenous administration

Primary outcomes

  1. Phase 1a: MTD and/or RP2D of LB-LR1109 as monotherapy in participants with advanced or metastatic solid tumors / Phase 1b: MTD and/or RP2D of LB-LR1109 as combination therapy with atezolizumab in participants with advanced or metastatic NSCLC

    Time frame: through study completion, an average of 1year

    Number of participants with dose-limiting toxicities (DLTs)

  2. Phase 1a: Incidence of Treatment-Emergent Adverse Events of LB-LR1109 as monotherapy / Phase 1b: Incidence of Treatment-Emergent Adverse Events of LB-LR1109 as combination therapy with atezolizumab

    Time frame: through study completion, an average of 1year

    Incidence, severity (assessed by NCI CTCAE v5.0), and causality of AEs

Secondary outcomes

  1. Phase 1a / 1b: Preliminary efficacy of LB-LR1109 as monotherapy and as combination therapy with atezolizumab

    Time frame: through study completion, an average of 1year

    ORR(overall response rate) assessed by RECIST v1.1 (%)

  2. Phase 1a / 1b: Antitumor efficacy of LB-LR1109 as monotherapy and as combination therapy with atezolizumab

    Time frame: through study completion, an average of 1year

    PFS(Progression free survival)

  3. Phase 1a/1b: Antitumor efficacy of LB-LR1109 as monotherapy and as combination therapy with atezolizumab

    Time frame: through study completion, an average of 1year

    OS (Overall survival) (months)

  4. Phase 1a / 1b: Pharmacokinetic profile of LB-LR1109 as monotherapy and as combination therapy with atezolizumab

    Time frame: through study completion, an average of 1year

    Cmax (Maximum serum drug concentration)

  5. Phase 1a / 1b: Characterize PK of LB-LR1109 as monotherapy and as combination therapy with atezolizumab

    Time frame: through study completion, an average of 1year

    Area under the concentration-time curve (AUC) 0-last

  6. Phase 1a / 1b: Immunogenicity of LB-LR1109 as monotherapy and as combination therapy with atezolizumab

    Time frame: through study completion, an average of 1year

    Number and percentage of participants with ADAs

Sponsors and collaborators

Lead sponsor

LG Chem

Industry

Registry information

Official study title

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)

Acronym: LB-LR1109

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Mar 27, 2024
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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