Study to Evaluate LB-LR1109, Administered Alone for the Treatment of Solid Tumor and in Combination With Atezolizumab for the Treatment of NSCLC
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)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests the safety and dose of LB-LR1109, alone or with atezolizumab, and looks for early signs that it works. It is for adults with certain advanced cancers or cancers that have spread; the two-drug treatment is only for people with non-small cell lung cancer.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 or older.
- For Phase 1a: Have cancer confirmed by a tissue test in the lung, head and neck, kidney, urinary tract, or skin (melanoma). The cancer must be advanced or have spread.
- For Phase 1a: Have cancer that has spread and worsened during or after standard treatment, or be unable or unwilling to receive standard treatment.
- For Phase 1b: Have advanced or spread non-small cell lung cancer confirmed by a tissue test. It must be measurable and have no gene changes with approved treatments where you live.
- Be fully active or able to do light work, and be expected to live at least 12 weeks.
- Have organs that work well enough for the study.
- Be unable to have children or agree to use suitable birth control.
- Understand the study and be willing to sign a consent form.
Who can't join
- Have serious heart disease or heart failure, or another active cancer at the same time.
- Have untreated or unstable cancer spread to the brain or spinal cord, or cancer in the lining around them.
- Have had treatment targeting the LILRB pathway, a signal system in immune cells. For Phase 1b, prior atezolizumab treatment also rules you out.
- Have had life-threatening side effects from immune treatment, or still have more than mild side effects from earlier cancer treatment or surgery that have not returned to your usual level.
- Have a known or suspected active autoimmune disease, where the immune system attacks the body.
- Have an active infection needing antibiotics through a vein within 7 days before study treatment. Some viruses linked to the cancer being studied are exceptions.
- Be pregnant, breastfeeding, or planning to conceive a child during the study or within 6 months after the last dose.
- Have another condition that the study doctor thinks could make participation unsafe, prevent full participation, or affect the study results.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility 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
Study sites (1)
VA
- NEXT Oncology · Fairfax, VA 22031Alexander Spirra · Study contact · (703)-783-4508 · alexander.spira@usoncology.comMore trials in Fairfax