Evaluating LB-LR1109 for treating solid tumors
A Phase 1a/1b, First-in-Human, Open-Label, Multi-Center, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LB-LR1109, When Administered Alone for the Treatment of Advanced or Metastatic Solid Tumors, and in Combination With Atezolizumab for the Treatment of Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)
This study is testing a new treatment called LB-LR1109 to see how safe it is and how well it works for people with advanced solid tumors that can't be treated with standard options.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 76 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | LG Chem Industry-sponsored |
| Drugs / interventions | atezolizumab |
| Locations | 1 site (Fairfax, Virginia) |
| Trial ID | NCT06332755 on ClinicalTrials.gov |
What this trial studies
This Phase 1, first-in-human, multi-center, open-label study aims to determine the maximum tolerated dose and recommended Phase 2 dose of LB-LR1109. It will evaluate the safety, tolerability, preliminary efficacy, pharmacokinetics, immunogenicity, and pharmacodynamics of LB-LR1109 in patients with unresectable and metastatic solid tumors, including non-small cell lung cancer, head and neck squamous cell carcinoma, renal cell carcinoma, urothelial carcinoma, and malignant melanoma. Participants must have advanced disease with no available standard treatment options.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with advanced or metastatic solid tumors that have progressed after standard therapies or for whom standard therapies are not an option.
Not a fit: Patients with early-stage tumors or those who have not yet undergone standard treatment options may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors who have exhausted standard care.
How similar studies have performed: Other studies evaluating similar immunotherapeutic approaches have shown promising results, indicating potential for success in this novel treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
Key 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 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. 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
Where this trial is running
Fairfax, Virginia
- NEXT Oncology — Fairfax, Virginia, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.