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)

NCT06332755 Phase 1 RECRUITING

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.

Details

Lead sponsor	LG Chem
Phase	Phase 1
Status	RECRUITING
Enrolment	76
Start date	2024-06-05
Completion	2028-03

Conditions

• Non-small Cell Lung Cancer(NSCLC)
• Head and Neck Squamous Cell Carcinoma(HNSCC)
• Renal Cell Carcinoma(RCC)
• Urothelial Carcinoma
• Malignant Melanoma

Interventions

• Phase 1a: LB-LR1109
• Phase 1b: LB-LR1109 and Atezolizumab

Primary outcomes

• 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 — through study completion, an average of 1year
  Number of participants with dose-limiting toxicities (DLTs)
• 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 — through study completion, an average of 1year
  Incidence, severity (assessed by NCI CTCAE v5.0), and causality of AEs

Countries

United States