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

NCT06332755 | Recruiting Phase 1 FDA Drug

• 1 other identifier: LG-LRCL001
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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

Keywords

solid tumor

Outcome Measures

Primary Outcomes (2)

• 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)

  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

  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

  through study completion, an average of 1year

• Phase 1a / 1b: Antitumor efficacy of LB-LR1109 as monotherapy and as combination therapy with atezolizumab

  through study completion, an average of 1year

• Phase 1a/1b: Antitumor efficacy of LB-LR1109 as monotherapy and as combination therapy with atezolizumab

  through study completion, an average of 1year

• Phase 1a / 1b: Pharmacokinetic profile of LB-LR1109 as monotherapy and as combination therapy with atezolizumab

  through study completion, an average of 1year

• Phase 1a / 1b: Characterize PK of LB-LR1109 as monotherapy and as combination therapy with atezolizumab

  through study completion, an average of 1year

Study Arms (2)

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

Interventions

Phase 1a: LB-LR1109 DRUG

intravenous administration

phase 1a: Dose escalation / LB-LR1109 monotherapy

Phase 1b: LB-LR1109 and Atezolizumab DRUG

intravenous administration

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• LG Chem: lead

Study Sites (1)

NEXT Oncology

Fairfax, Virginia, 22031, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Squamous Cell Carcinoma of Head and Neck; Carcinoma, Renal Cell; Carcinoma, Transitional Cell; Melanoma

Interventions

atezolizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Head and Neck Neoplasms; Adenocarcinoma; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2024
• First Posted: March 27, 2024
• Study Start: June 5, 2024
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: November 24, 2025

Record last verified: 2025-11

Locations

US (1)