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

Launched by LG CHEM · Mar 22, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called LB-LR1109 for patients with certain types of advanced cancer, including non-small cell lung cancer, head and neck cancer, kidney cancer, bladder cancer, and malignant melanoma. This is a Phase 1 study, meaning it’s the first time this treatment is being tested in humans. The main goals are to find out the highest dose that can be safely given and to learn more about how the treatment works, its side effects, and how it might improve patients' quality of life.

To participate, individuals must be at least 18 years old and have a confirmed diagnosis of one of the specified cancers that have not responded to existing treatments. They should also be able to provide a sample of their tumor tissue and have a good performance status, meaning they can carry out daily activities with minimal issues. Participants will receive LB-LR1109 and will be monitored closely for safety and effectiveness. It's important to note that individuals with certain health conditions or who are pregnant or breastfeeding cannot participate. This trial is currently recruiting participants, and those who join will be contributing to important research that could help many others in the future.

Gender

ALL

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.