Clinical trial NCT06332755: Study to Evaluate LB-LR1109 for the Treatment of Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
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
Lead sponsor: LG Chem
Sponsor class: INDUSTRY
First posted: 2024-03-27
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 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.

Primary outcomes:
measure: MTD and/or RP2D of LB-LR1109 in participants with advanced or metastatic solid tumors
timeFrame: through study completion, an average of 1year
measure: Incidence of Treatment-Emergent Adverse Events of LB-LR1109
timeFrame: through study completion, an average of 1year
Secondary outcomes:
measure: Preliminary efficacy of LB-LR1109
timeFrame: through study completion, an average of 1year
measure: Anti-tumor efficacy of LB-LR1109
timeFrame: through study completion, an average of 1year
measure: Pharmacokinetic profile of LB-LR1109
timeFrame: through study completion, an average of 1year
measure: Characterize PK of LB-LR1109
timeFrame: through study completion, an average of 1year
measure: Immunogenicity of LB-LR1109
timeFrame: through study completion, an average of 1year
measure: Quality of life of participants
timeFrame: through study completion, an average of 1year
Other outcomes:
Locations:
city: Fairfax
country: United States
facility: NEXT Oncology
state: Virginia
Study officials:
References: