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

Study acronym: LB-LR1109
StatusRecruiting
PhasePhase 1
SponsorLG Chem
Started
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Record History

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  1. Enrollment target: 42 to 76v4 Show 9 more changesShow less
    • Primary completion date: Nov 2025 to Nov 2027
    • Primary endpoints revised (2)
    • Study completion date: Feb 2027 to Mar 2028
    • Interventions: LB-LR1109 (Drug) to Phase 1a: LB-LR1109 (Drug), Phase 1b: LB-LR1109 and Atezolizumab (Drug)
    • Eligibility criteria expanded, about 24 words
    • Secondary endpoints revised (6)
    • Site contact updated
    • Study title expanded, about 12 words
    • Study arms: 1 to 2
  2. Eligibility criteria shortened, about 1 wordv3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of May 2024 to Jun 5, 2024
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
LG Chem
13 trials monitored
See 1 trial at risk
Lung Cancer
4,790 trials monitored
See 263 trials at risk
Non-Small Cell Lung Cancer (NSCLC)
3,078 trials monitored
See 172 trials at risk
Head & Neck Cancer
2,605 trials monitored
See 150 trials at risk
and 3 more diseases
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.
Trial Details
NCT Number NCT06332755
Lead Sponsor LG Chem
Conditions
(from sponsor)		 Non-small Cell Lung Cancer(NSCLC), Head and Neck Squamous Cell Carcinoma(HNSCC), Renal Cell Carcinoma(RCC), Urothelial Carcinoma, Malignant Melanoma
Related terms Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Carcinoma, Transitional Cell, Melanoma, Squamous Cell Carcinoma of Head and Neck
Enrollment 76 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov