Taking people in United StatesPhase 1
Tests LB-LR1109 alone and with atezolizumab in advanced solid tumors and lung cancer
Tests LB-LR1109, alone or with atezolizumab, in adults with advanced cancers including lung cancer.
Key facts
- Who runs it
- LG Chem
- Where
- Fairfax, United StatesSee the site
- Trial code
- Registry title
- Study to Evaluate LB-LR1109, Administered Alone for the Treatment of Solid Tumor and in Combination With Atezolizumab for the Treatment of NSCLC
- Status
- Recruiting
- Phase
- Phase 1
- People taking part
- 76 people, planned
- Started
- 5 Jun 2024
- Expected to end
- Mar 2028
- Type of study
- Interventional, 2 groups
- Treatments tested
- Phase 1a: LB-LR1109
- Phase 1b: LB-LR1109 and Atezolizumab
- Record updated
- 24 November 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced or metastatic non-small cell lung cancer, head and neck squamous cell carcinoma, kidney cancer, urothelial cancer or melanoma. Phase 1b is only for lung cancer.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Advanced or metastatic cancer confirmed by tissue examination. Phase 1a: NSCLC, HNSCC, RCC, urothelial carcinoma or malignant melanoma. Phase 1b: NSCLC only.
- Earlier treatment
- Phase 1a: the cancer has spread and got worse during or after approved standard treatments, or the person cannot take or refuses them. Phase 1b: no earlier atezolizumab. No earlier treatment aimed at LILRB or the immunoglobulin-like transcript pathway.
- Biomarker or test result
- Phase 1b: lung cancer with no gene change for which approved therapies exist where the person lives.
Main reasons for not taking part
- Significant heart disease or heart failure
- Untreated or unstable brain or central nervous system metastases, or leptomeningeal disease
- Another active cancer at the same time
- Active, known or suspected autoimmune disease
- Pregnant or breastfeeding, or planning a child during the study or within 6 months after the last dose
The registry criteria, word for word
Show all 20 criteriaShow less
Who can take part
- 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,; NSCLC, HNSCC, RCC, urothelial carcinoma, or malignant melanoma
- (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
- 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
- (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
Who cannot take part
- Participants with any concurrent active malignancies
- Has received prior therapy targeting LILRB or immunoglobulin-like transcript pathway
- History of life-threatening toxicity related to prior immune therapy
- 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
- 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)
- (Phase 1b only) Participants who were previously exposed to atezolizumab
- Clinically significant cardiac disease or cardiac failure
- Untreated or unstable brain or central nervous system (CNS) metastases or Leptomeningeal disease
- Participants must not have an active, known, or suspected autoimmune disease
- 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
- Pregnant or lactating or expecting to conceive a child during the study or within 6 months after the last dose of study intervention
Where in United States
- NEXT OncologyFairfax, United StatesContact: Alexander SpirraTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- phase 1a: Dose escalation / LB-LR1109 monotherapyTreatment being tested
Treatment: Phase 1a: LB-LR1109
- Phase 1b: Dose escalation / LB-LR1109 in combination with AtezolizumabTreatment being tested
Treatment: Phase 1b: LB-LR1109 and Atezolizumab
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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)
- Plain-language title
- Tests LB-LR1109 alone and with atezolizumab in advanced solid tumors and lung cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 24 November 2025