A Phase 1, First-in-Human, Open-Label, Multi-Center, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LB-LR1109 for the Treatment of Advanced or Metastatic Solid Tumors
This is a Phase 1, 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) of LB-LR1109 and to evaluate safety, tolerability, preliminary efficacy, pharmacokinetics, immunogenicity, pharmacodynamics of LB-LR1109, and its impact on quality of life in participants with unresectable and metastatic nonsmall 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.
• Age ≥18 years old at the time of signing the ICF.
• 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,
• \- NSCLC, HNSCC, RCC, urothelial carcinoma, or malignant melanoma.
• Participants who have metastatic disease which has progressed during or after approved standard therapies or are intolerant to all approved therapies, or for which the participant refuses or is ineligible for standard therapy.
• Able to submit the most recently obtained archival tumor tissue
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1.
• Life expectancy ≥12 weeks.
• Participants with adequate organ function
• No potential for childbearing or agree to use adequate contraception
• Ability to understand the study purpose and procedures and have the willingness to sign a written informed consent document.