Head and Neck Squamous Cell Carcinoma(HNSCC), Malignant Melanoma, Non-small Cell Lung Cancer(NSCLC), Renal Cell Carcinoma(RCC), Urothelial Carcinoma
Conditions
Keywords
solid tumor
Brief 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.
Interventions
DRUGPhase 1a: LB-LR1109
intravenous administration
DRUGPhase 1b: LB-LR1109 and Atezolizumab
intravenous administration
Sponsors
LG Chem
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Age ≥18 years old at the time of signing the ICF. 2. (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, \- NSCLC, HNSCC, RCC, urothelial carcinoma, or malignant melanoma. 3. (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. 4. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1. 5. Life expectancy ≥12 weeks. 6. Participants with adequate organ function 7. No potential for childbearing or agree to use adequate contraception 8. Ability to understand the study purpose and procedures and have the willingness to sign a written informed consent document. 9. (Phase 1b only ) Must have histologically confirmed advanced or metastatic NSCLC without actionable genomic alteration that have approved therapies in the location where the participant's live and with measurable disease as determined by RECIST v1.1 Key
Exclusion criteria
1. Clinically significant cardiac disease or cardiac failure. 2. Untreated or unstable brain or central nervous system (CNS) metastases or Leptomeningeal disease 3. Participants with any concurrent active malignancies 4. Has received prior therapy targeting LILRB or immunoglobulin-like transcript pathway. 5. History of life-threatening toxicity related to prior immune therapy 6. Has not recovered to ≤ Grade 1 or baseline from AEs and/or complications from prior surgical intervention or any anti-cancer treatment before starting study treatment 7. Participants must not have an active, known, or suspected autoimmune disease. 8. Evidence of active infection requiring IV antibiotic treatment ≤7 days prior to initiation of study treatment therapy (does not apply to viral infections that are presumed to be associated with the underlying tumor type required for study entry). 9. Pregnant or lactating or expecting to conceive a child during the study or within 6 months after the last dose of study intervention. 10. Any condition that would, in the Investigator's judgment, interfere with full participation in the study, including administration of study intervention and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data. 11. (Phase 1b only) Participants who were previously exposed to atezolizumab
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | through study completion, an average of 1year | 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 | through study completion, an average of 1year | Incidence, severity (assessed by NCI CTCAE v5.0), and causality of AEs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1a/1b: Antitumor efficacy of LB-LR1109 as monotherapy and as combination therapy with atezolizumab | through study completion, an average of 1year | OS (Overall survival) (months) |
| Phase 1a / 1b: Pharmacokinetic profile of LB-LR1109 as monotherapy and as combination therapy with atezolizumab | through study completion, an average of 1year | Cmax (Maximum serum drug concentration) |
| Phase 1a / 1b: Preliminary efficacy of LB-LR1109 as monotherapy and as combination therapy with atezolizumab | through study completion, an average of 1year | ORR(overall response rate) assessed by RECIST v1.1 (%) |
| Phase 1a / 1b: Immunogenicity of LB-LR1109 as monotherapy and as combination therapy with atezolizumab | through study completion, an average of 1year | Number and percentage of participants with ADAs |
| Phase 1a / 1b: Characterize PK of LB-LR1109 as monotherapy and as combination therapy with atezolizumab | through study completion, an average of 1year | Area under the concentration-time curve (AUC) 0-last |
| Phase 1a / 1b: Antitumor efficacy of LB-LR1109 as monotherapy and as combination therapy with atezolizumab | through study completion, an average of 1year | PFS(Progression free survival) |
Countries
United States
Outcome results
None listed