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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
76
intravenous administration
intravenous administration
NEXT Oncology
Fairfax, Virginia, United States
RECRUITINGPhase 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
Number of participants with dose-limiting toxicities (DLTs)
Time frame: through study completion, an average of 1year
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
Incidence, severity (assessed by NCI CTCAE v5.0), and causality of AEs
Time frame: through study completion, an average of 1year
Phase 1a / 1b: Preliminary efficacy of LB-LR1109 as monotherapy and as combination therapy with atezolizumab
ORR(overall response rate) assessed by RECIST v1.1 (%)
Time frame: through study completion, an average of 1year
Phase 1a / 1b: Antitumor efficacy of LB-LR1109 as monotherapy and as combination therapy with atezolizumab
PFS(Progression free survival)
Time frame: through study completion, an average of 1year
Phase 1a/1b: Antitumor efficacy of LB-LR1109 as monotherapy and as combination therapy with atezolizumab
OS (Overall survival) (months)
Time frame: through study completion, an average of 1year
Phase 1a / 1b: Pharmacokinetic profile of LB-LR1109 as monotherapy and as combination therapy with atezolizumab
Cmax (Maximum serum drug concentration)
Time frame: through study completion, an average of 1year
Phase 1a / 1b: Characterize PK of LB-LR1109 as monotherapy and as combination therapy with atezolizumab
Area under the concentration-time curve (AUC) 0-last
Time frame: through study completion, an average of 1year
Phase 1a / 1b: Immunogenicity of LB-LR1109 as monotherapy and as combination therapy with atezolizumab
Number and percentage of participants with ADAs
Time frame: through study completion, an average of 1year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.