RECRUITING

Study to Evaluate LB-LR1109, Administered Alone for the Treatment of Solid Tumor and in Combination With Atezolizumab for the Treatment of NSCLC

Conditions

Non-small Cell Lung Cancer(NSCLC)Head and Neck Squamous Cell Carcinoma(HNSCC)Renal Cell Carcinoma(RCC)Urothelial Carcinoma Malignant Melanoma solid tumor

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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)

Quick Facts

Study Start:2024-06-05

Study Completion:2028-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06332755

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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, 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	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

Inclusion Criteria

Exclusion 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,
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

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

Contacts and Locations

Study Locations (Sites)

NEXT Oncology

Fairfax, Virginia, 22031

United States

Collaborators and Investigators

Sponsor: LG Chem

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-05

Study Completion Date2028-03

Study Record Updates

Study Start Date2024-06-05

Study Completion Date2028-03

Terms related to this study

Keywords Provided by Researchers

solid tumor

Additional Relevant MeSH Terms

Non-small Cell Lung Cancer(NSCLC)
Head and Neck Squamous Cell Carcinoma(HNSCC)
Renal Cell Carcinoma(RCC)
Urothelial Carcinoma
Malignant Melanoma