Study to Evaluate LB-LR1109, Administered Alone for the Treatment of Solid Tumor and in Combination With Atezolizumab for the Treatment of NSCLC (LB-LR1109)

November 19, 2025 updated by: LG Chem

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

76

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: phase 1a: Dose escalation / LB-LR1109 monotherapy
Drug: Phase 1a: LB-LR1109
intravenous administration
Experimental: Phase 1b: Dose escalation / LB-LR1109 in combination with Atezolizumab
Drug: Phase 1b: LB-LR1109 and Atezolizumab
intravenous administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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
Incidence, severity (assessed by NCI CTCAE v5.0), and causality of AEs
through study completion, an average of 1year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
ORR(overall response rate) assessed by RECIST v1.1 (%)
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
PFS(Progression free survival)
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
OS (Overall survival) (months)
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
Cmax (Maximum serum drug concentration)
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
Area under the concentration-time curve (AUC) 0-last
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
Number and percentage of participants with ADAs
through study completion, an average of 1year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LG Chem

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 5, 2024

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

February 16, 2024

First Submitted That Met QC Criteria

March 22, 2024

First Posted (Actual)

March 27, 2024

Study Record Updates

Last Update Posted (Actual)

November 24, 2025

Last Update Submitted That Met QC Criteria

November 19, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LG-LRCL001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Urothelial Carcinoma

Clinical Trials on Phase 1a: LB-LR1109

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Spain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe