NEXT Oncology
Fairfax, Virginia, 22031, United States
Location status: Recruiting
NCT Number: NCT06332755
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 1
Fairfax, Virginia, 22031, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
intravenous administration
intravenous administration
Time frame: through study completion, an average of 1year
Number of participants with dose-limiting toxicities (DLTs)
Time frame: through study completion, an average of 1year
Incidence, severity (assessed by NCI CTCAE v5.0), and causality of AEs
Time frame: through study completion, an average of 1year
ORR(overall response rate) assessed by RECIST v1.1 (%)
Time frame: through study completion, an average of 1year
PFS(Progression free survival)
Time frame: through study completion, an average of 1year
OS (Overall survival) (months)
Time frame: through study completion, an average of 1year
Cmax (Maximum serum drug concentration)
Time frame: through study completion, an average of 1year
Area under the concentration-time curve (AUC) 0-last
Time frame: through study completion, an average of 1year
Number and percentage of participants with ADAs
LG Chem
Industry
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)
Acronym: LB-LR1109
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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