Evaluating LB-LR1109 for treating solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• NEXT Oncology
  Fairfax, Virginia, United States Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.