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New treatment option for Non-small Cell Lung Cancer(NSCLC)
Official title Study to Evaluate LB-LR1109, Administered Alone for the Treatment of Solid Tumor and in Combination With Atezolizumab for the Treatment of NSCLC
ClinicalTrials.gov ID: NCT06332755
What this study is testing
What is Phase 1a: LB-LR1109?
Phase 1a: LB-LR1109 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for non-small cell lung cancer(nsclc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase 1a/1b, 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) and to evaluate safety, tolerability, preliminary efficacy, pharmacokinetics, immunogenicity, pharmacodynamics of LB-LR1109 as monotherapy in participants with advanced and/or metastatic non small 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, and as combination therapy with atezolizumab in participants with advanced and/or metastatic NSCLC.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥18 years old at the time of signing the ICF.
- (Phase 1a only) Participants must have 1 of the following histologically confirmed advanced or metastatic solid tumors with measurable or...
- (Phase 1a only) Participants who have metastatic disease which has progressed during or after approved standard therapies or are intolerant to...
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1.
- Life expectancy ≥12 weeks.
You likely can't join if
- Clinically significant cardiac disease or cardiac failure.
- Untreated or unstable brain or central nervous system (CNS) metastases or Leptomeningeal disease
- Participants with any concurrent active malignancies
- Has received prior therapy targeting LILRB or immunoglobulin-like transcript pathway.
- History of life-threatening toxicity related to prior immune therapy
- Has not recovered to ≤ Grade 1 or baseline from AEs and/or complications from prior surgical intervention or any anti-cancer treatment before...
See the full eligibility criteria
- Age ≥18 years old at the time of signing the ICF.
- (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...
- (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...
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1.
- Life expectancy ≥12 weeks.
- Participants with adequate organ function
- No potential for childbearing or agree to use adequate contraception
- Ability to understand the study purpose and procedures and have the willingness to sign a written informed consent document.
- (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...
- Clinically significant cardiac disease or cardiac failure.
- Untreated or unstable brain or central nervous system (CNS) metastases or Leptomeningeal disease
- Participants with any concurrent active malignancies
- Has received prior therapy targeting LILRB or immunoglobulin-like transcript pathway.
- History of life-threatening toxicity related to prior immune therapy
- 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
- Participants must not have an active, known, or suspected autoimmune disease.
- 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...
- Pregnant or lactating or expecting to conceive a child during the study or within 6 months after the last dose of study intervention.
- 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...
- (Phase 1b only) Participants who were previously exposed to atezolizumab
The study team makes the final eligibility decision.
Where it's taking place
- Fairfax, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fairfax, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.