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

Urothelial Carcinoma Clinical Trial

— LB-LR1109  

Official title:

A Phase 1, First-in-Human, Open-Label, Multi-Center, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LB-LR1109 for the Treatment of Advanced or Metastatic Solid Tumors

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06332755
• Other study ID #: LG-LRCL001
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: May 2024
• Est. completion date: February 2027

Study information

• Verified date: March 2024
• Source: LG Chem
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 42
• Est. completion date: February 2027
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key 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 all 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 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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Malignant Melanoma
• Melanoma
• Non-small Cell Lung Cancer(NSCLC)
• Squamous Cell Carcinoma of Head and Neck
• Urothelial Carcinoma

Intervention

Drug:
• LB-LR1109
intravenous administration

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
LG Chem

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MTD and/or RP2D of LB-LR1109 in participants with advanced or metastatic solid tumors	Number of participants with dose-limiting toxicities (DLTs)	through study completion, an average of 1year
Primary	Incidence of Treatment-Emergent Adverse Events of LB-LR1109	Incidence, severity (assessed by NCI CTCAE v5.0), and causality of AEs	through study completion, an average of 1year
Secondary	Preliminary efficacy of LB-LR1109	ORR(overall response rate) assessed by RECIST v1.1 (%)	through study completion, an average of 1year
Secondary	Anti-tumor efficacy of LB-LR1109	PFS(Progression free survival) and OS(Overall survival) (months)	through study completion, an average of 1year
Secondary	Pharmacokinetic profile of LB-LR1109	Cmax (Maximum serum drug concentration)	through study completion, an average of 1year
Secondary	Characterize PK of LB-LR1109	Area under the concentration-time curve (AUC) 0-last	through study completion, an average of 1year
Secondary	Immunogenicity of LB-LR1109	Number and percentage of participants with ADAs	through study completion, an average of 1year
Secondary	Quality of life of participants	assessed by EORTC QLQ-C30	through study completion, an average of 1year