Recruiting
Phase 1

LB-LR1109

Sponsor:

LG Chem

Code:

NCT06332755

Conditions

Non-small Cell Lung Cancer(NSCLC)

Head and Neck Squamous Cell Carcinoma(HNSCC)

Renal Cell Carcinoma(RCC)

Urothelial Carcinoma

Malignant Melanoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Phase 1a: LB-LR1109

Phase 1b: LB-LR1109 and Atezolizumab

Study Details

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.

Conditions

Non-small Cell Lung Cancer(NSCLC)

Head and Neck Squamous Cell Carcinoma(HNSCC)

Renal Cell Carcinoma(RCC)

Urothelial Carcinoma

Malignant Melanoma

Study ID

NCT06332755

Start date

Jun 5, 2024

Status verified date

Nov, 2025

Completion date

Mar, 2028

Anticipated

Primary completion date

Nov, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

76 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: phase 1a: Dose escalation / LB-LR1109 monotherapy

experimental: Phase 1b: Dose escalation / LB-LR1109 in combination with Atezolizumab

Interventions

Phase 1a: LB-LR1109

intravenous administration

Phase 1b: LB-LR1109 and Atezolizumab

intravenous administration

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 ]
  • 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 ]

Central Contacts and Locations

Locations

NEXT Oncology

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

More Information

Sponsor

LG Chem

Last update posted

Nov 24, 2025

Last verified

Nov, 2025

Keywords

  • solid tumor

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by LG Chem on 2025-11-24.