Study to Evaluate LB-LR1109, Administered Alone for the Treatment of Solid Tumor and in Combination With Atezolizumab for the Treatment of NSCLC
NCT06332755 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 76
Last updated 2025-11-24
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.
Conditions
- Non-small Cell Lung Cancer(NSCLC)
- Head and Neck Squamous Cell Carcinoma(HNSCC)
- Renal Cell Carcinoma(RCC)
- Urothelial Carcinoma
- Malignant Melanoma
Interventions
- DRUG
-
Phase 1a: LB-LR1109
intravenous administration
- DRUG
-
Phase 1b: LB-LR1109 and Atezolizumab
intravenous administration
Sponsors & Collaborators
-
LG Chem
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-06-05
- Primary Completion
- 2027-11-30
- Completion
- 2028-03-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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