Non-small Cell Lung Cancer(NSCLC)Phase 1LB-LR1109NCT06332755
Study to Evaluate LB-LR1109, Administered Alone for the Treatment of Solid Tumor and in Combination With Atezolizumab for the Treatment of NSCLC
A Phase 1 study testing Phase 1a: LB-LR1109 and Phase 1b: LB-LR1109 and Atezolizumab in people with Non-small Cell Lung Cancer(NSCLC) and Head and Neck Squamous Cell Carcinoma(HNSCC), run by LG Chem at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer(NSCLC), Head and Neck Squamous Cell Carcinoma(HNSCC), Renal Cell Carcinoma(RCC)
- What is being tested?
- Phase 1a: LB-LR1109 and Phase 1b: LB-LR1109 and Atezolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2024to Mar 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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 join
- 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.
- 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
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- Participants must not have an active, known, or suspected autoimmune disease.
- 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).
- Pregnant or lactating or expecting to conceive a child during the study or within 6 months after the last dose of study intervention.
- 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.
- (Phase 1b only) Participants who were previously exposed to atezolizumab
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NEXT Oncology
Fairfax, Virginia, 22031
Alexander Spirra, (703)-783-4508, alexander.spira@usoncology.com
About this study
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)
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.
- Conditions
- Non-small Cell Lung Cancer(NSCLC), Head and Neck Squamous Cell Carcinoma(HNSCC), Renal Cell Carcinoma(RCC), Urothelial Carcinoma, Malignant Melanoma
- Being tested
- Phase 1a: LB-LR1109, Phase 1b: LB-LR1109 and Atezolizumab
- Keywords
- solid tumor
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of Head and Neck, Carcinoma, Renal Cell, Carcinoma, Transitional Cell, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phase 1a: LB-LR1109Drug
intravenous administration
Phase 1b: LB-LR1109 and AtezolizumabDrug
intravenous administration
| Study group | Role | What they receive |
|---|---|---|
| phase 1a: Dose escalation / LB-LR1109 monotherapy | Experimental | Not described Receives: Drug: Phase 1a: LB-LR1109 |
| Phase 1b: Dose escalation / LB-LR1109 in combination with Atezolizumab | Experimental | Not described Receives: Drug: Phase 1b: LB-LR1109 and Atezolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: through study completion, an average of 1year
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
Measured: through study completion, an average of 1year
Secondary outcomes (6)
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 (%)
Measured: through study completion, an average of 1year
Phase 1a / 1b: Antitumor efficacy of LB-LR1109 as monotherapy and as combination therapy with atezolizumab
PFS(Progression free survival)
Measured: through study completion, an average of 1year
Phase 1a/1b: Antitumor efficacy of LB-LR1109 as monotherapy and as combination therapy with atezolizumab
OS (Overall survival) (months)
Measured: through study completion, an average of 1year
Phase 1a / 1b: Pharmacokinetic profile of LB-LR1109 as monotherapy and as combination therapy with atezolizumab
Cmax (Maximum serum drug concentration)
Measured: through study completion, an average of 1year
Phase 1a / 1b: Characterize PK of LB-LR1109 as monotherapy and as combination therapy with atezolizumab
Area under the concentration-time curve (AUC) 0-last
Measured: through study completion, an average of 1year
Phase 1a / 1b: Immunogenicity of LB-LR1109 as monotherapy and as combination therapy with atezolizumab
Number and percentage of participants with ADAs
Measured: through study completion, an average of 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start5 Jun 2024
- Primary completionNov 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung Cancer(NSCLC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LG Chem
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06332755
- Sponsor's protocol ID
- LG-LRCL001
- Acronym
- LB-LR1109
- Status last verified
- Nov 2025
- First submitted
- 16 Feb 2024
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06332755
- Acronym / sponsor ID
- LB-LR1109 / LG-LRCL001
- Conditions
- Non-small Cell Lung Cancer(NSCLC), Head and Neck Squamous Cell Carcinoma(HNSCC), Renal Cell Carcinoma(RCC), Urothelial Carcinoma, Malignant Melanoma
- Keywords
- solid tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- LG ChemIndustry (pharma, biotech, devices)
- Study start
- 5 Jun 2024 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 27 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| phase 1a: Dose escalation / LB-LR1109 monotherapy | Experimental | Drug: Phase 1a: LB-LR1109 |
| Phase 1b: Dose escalation / LB-LR1109 in combination with Atezolizumab | Experimental | Drug: Phase 1b: LB-LR1109 and Atezolizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
- Life expectancy ≥12 weeks.
Key exclusion criteria (11 listed)
- 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.
- History of life-threatening toxicity related to prior immune therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phase 1a: LB-LR1109intravenous administration | Drug | phase 1a: Dose escalation / LB-LR1109 monotherapy |
| Phase 1b: LB-LR1109 and Atezolizumabintravenous administration | Drug | Phase 1b: Dose escalation / LB-LR1109 in combination with Atezolizumab |
Primary outcome
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
Time frame: 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
Time frame: through study completion, an average of 1year
Incidence, severity (assessed by NCI CTCAE v5.0), and causality of AEs
6 secondary outcomes
Phase 1a / 1b: Preliminary efficacy of LB-LR1109 as monotherapy and as combination therapy with atezolizumab
Time frame: through study completion, an average of 1year
Phase 1a / 1b: Antitumor efficacy of LB-LR1109 as monotherapy and as combination therapy with atezolizumab
Time frame: through study completion, an average of 1year
Phase 1a/1b: Antitumor efficacy of LB-LR1109 as monotherapy and as combination therapy with atezolizumab
Time frame: through study completion, an average of 1year
Phase 1a / 1b: Pharmacokinetic profile of LB-LR1109 as monotherapy and as combination therapy with atezolizumab
Time frame: through study completion, an average of 1year
Phase 1a / 1b: Characterize PK of LB-LR1109 as monotherapy and as combination therapy with atezolizumab
Time frame: through study completion, an average of 1year
Phase 1a / 1b: Immunogenicity of LB-LR1109 as monotherapy and as combination therapy with atezolizumab
Time frame: through study completion, an average of 1year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Phase 1a: LB-LR1109 and Phase 1b: LB-LR1109 and Atezolizumab in people with Non-small Cell Lung Cancer(NSCLC) and Head and Neck Squamous Cell Carcinoma(HNSCC), run by LG Chem at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: through study completion, an average of 1year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.