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

NCT ID: NCT06332755

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-05
• Study Completion Date: 2028-03-31

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 Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

phase 1a: Dose escalation / LB-LR1109 monotherapy

Group Type: EXPERIMENTAL

Phase 1a: LB-LR1109

Intervention Type: DRUG

intravenous administration

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

Group Type: EXPERIMENTAL

Phase 1b: LB-LR1109 and Atezolizumab

Intervention Type: DRUG

intravenous administration

Interventions

Phase 1a: LB-LR1109

intravenous administration

Intervention Type: DRUG

Phase 1b: LB-LR1109 and Atezolizumab

intravenous administration

Intervention Type: DRUG

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LG Chem

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

NEXT Oncology

Fairfax, Virginia, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Alexander Spirra

Role: primary

alexander.spira@usoncology.com

(703)-783-4508

Other Identifiers

LG-LRCL001

Identifier Type: -

Identifier Source: org_study_id