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)
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.
Arms & interventions
- DrugPhase 1a: LB-LR1109
intravenous administration
- DrugPhase 1b: LB-LR1109 and Atezolizumab
intravenous administration
Outcome measures
Primary
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
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
Secondary
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
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
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
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
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
Phase 1a / 1b: Immunogenicity of LB-LR1109 as monotherapy and as combination therapy with atezolizumab
Time frame: through study completion, an average of 1year
Eligibility criteria
Study locations (1)
NEXT Oncology
Fairfax, Virginia, 22031