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.
Age ≥18 years old at the time of signing the ICF.
(Phase 1a only) Participants must have 1 of the following histologically confirmed advanced or metastatic solid tumors with measurable or non-measurable disease as determined by RECIST v1.1,
(Phase 1a only) Participants who have metastatic disease which has progressed during or after approved standard therapies or are intolerant to approved therapies, or for which the participant refuses or is ineligible for standard therapy.
Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1.
Clinically significant cardiac disease or cardiac failure.
Untreated or unstable brain or central nervous system (CNS) metastases or Leptomeningeal disease
Participants with any concurrent active malignancies
Has received prior therapy targeting LILRB or immunoglobulin-like transcript pathway.
Sequential
Phase 1a: LB-LR1109
Drugintravenous administration
Phase 1b: LB-LR1109 and Atezolizumab
Drugintravenous administration
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)
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
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 (%)
Phase 1a / 1b: Antitumor efficacy of LB-LR1109 as monotherapy and as combination therapy with atezolizumab
PFS(Progression free survival)
Phase 1a/1b: Antitumor efficacy of LB-LR1109 as monotherapy and as combination therapy with atezolizumab
OS (Overall survival) (months)
Phase 1a / 1b: Pharmacokinetic profile of LB-LR1109 as monotherapy and as combination therapy with atezolizumab
Cmax (Maximum serum drug concentration)
