Study to Evaluate LB-LR1109 for the Treatment of Solid Tumors

Phase 1

Recruiting

• Conditions: Urothelial Carcinoma; Renal Cell Carcinoma(RCC); Head and Neck Squamous Cell Carcinoma(HNSCC); Non-small Cell Lung Cancer(NSCLC); Malignant Melanoma
• Interventions: Drug: LB-LR1109

• Registration Number: NCT06332755
• Lead Sponsor: LG Chem

Brief Summary

This is a Phase 1, 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) of LB-LR1109 and to evaluate safety, tolerability, preliminary efficacy, pharmacokinetics, immunogenicity, pharmacodynamics of LB-LR1109, and its impact on quality of life in participants with unresectable and metastatic nonsmall 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2024-02-16
• Study First Submitted QC: 2024-03-22
• Study First Posted: 2024-03-27
• Study Start: 2024-06-05
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-01
• Last Update Posted: 2024-11-05
• Primary Completion: 2025-11
• Study Completion: 2027-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

1. Age ≥18 years old at the time of signing the ICF.

2. 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. Participants who have metastatic disease which has progressed during or after approved standard therapies or are intolerant to all approved therapies, or for which the participant refuses or is ineligible for standard therapy.

4. Able to submit the most recently obtained archival tumor tissue

5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1.

6. Life expectancy ≥12 weeks.

7. Participants with adequate organ function

8. No potential for childbearing or agree to use adequate contraception

9. Ability to understand the study purpose and procedures and have the willingness to sign a written informed consent document.

Key

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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. Prior LILRB or immunoglobulin-like transcript targeting therapy previously.
5. History of life-threatening toxicity related to prior immune therapy
6. Has not recovered to ≤ Grade 1 or baseline from AEs (except for toxicities not considered a safety risk such as alopecia, or asymptomatic laboratory abnormalities) due to prior therapy 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Dose Escalation	LB-LR1109	-

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events of LB-LR1109	through study completion, an average of 1year	Incidence, severity (assessed by NCI CTCAE v5.0), and causality of AEs
MTD and/or RP2D of LB-LR1109 in participants with advanced or metastatic solid tumors	through study completion, an average of 1year	Number of participants with dose-limiting toxicities (DLTs)

Secondary Outcome Measures

Name	Time	Method
Immunogenicity of LB-LR1109	through study completion, an average of 1year	Number and percentage of participants with ADAs
Preliminary efficacy of LB-LR1109	through study completion, an average of 1year	ORR(overall response rate) assessed by RECIST v1.1 (%)
Anti-tumor efficacy of LB-LR1109	through study completion, an average of 1year	PFS(Progression free survival) and OS(Overall survival) (months)
Pharmacokinetic profile of LB-LR1109	through study completion, an average of 1year	Cmax (Maximum serum drug concentration)
Characterize PK of LB-LR1109	through study completion, an average of 1year	Area under the concentration-time curve (AUC) 0-last
Quality of life of participants	through study completion, an average of 1year	assessed by EORTC QLQ-C30

Trial Locations

Locations (1)

NEXT Oncology; 🇺🇸 Fairfax, Virginia, United States