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

March 22, 2024 updated by: LG Chem

A Phase 1, First-in-Human, Open-Label, Multi-Center, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LB-LR1109 for the Treatment of Advanced or Metastatic Solid Tumors

This is a Phase 1, 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) of LB-LR1109 and to evaluate safety, tolerability, preliminary efficacy, pharmacokinetics, immunogenicity, pharmacodynamics of LB-LR1109, and its impact on quality of life in participants with unresectable and metastatic nonsmall 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

42

Phase

  • Phase 1

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 all 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose Escalation
Drug: LB-LR1109
intravenous administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MTD and/or RP2D of LB-LR1109 in participants with advanced or metastatic solid tumors
Time Frame: through study completion, an average of 1year
Number of participants with dose-limiting toxicities (DLTs)
through study completion, an average of 1year
Incidence of Treatment-Emergent Adverse Events of LB-LR1109
Time Frame: through study completion, an average of 1year
Incidence, severity (assessed by NCI CTCAE v5.0), and causality of AEs
through study completion, an average of 1year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preliminary efficacy of LB-LR1109
Time Frame: through study completion, an average of 1year
ORR(overall response rate) assessed by RECIST v1.1 (%)
through study completion, an average of 1year
Anti-tumor efficacy of LB-LR1109
Time Frame: through study completion, an average of 1year
PFS(Progression free survival) and OS(Overall survival) (months)
through study completion, an average of 1year
Pharmacokinetic profile of LB-LR1109
Time Frame: through study completion, an average of 1year
Cmax (Maximum serum drug concentration)
through study completion, an average of 1year
Characterize PK of LB-LR1109
Time Frame: through study completion, an average of 1year
Area under the concentration-time curve (AUC) 0-last
through study completion, an average of 1year
Immunogenicity of LB-LR1109
Time Frame: through study completion, an average of 1year
Number and percentage of participants with ADAs
through study completion, an average of 1year
Quality of life of participants
Time Frame: through study completion, an average of 1year
assessed by EORTC QLQ-C30
through study completion, an average of 1year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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 Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

February 16, 2024

First Submitted That Met QC Criteria

March 22, 2024

First Posted (Actual)

March 27, 2024

Study Record Updates

Last Update Posted (Actual)

March 27, 2024

Last Update Submitted That Met QC Criteria

March 22, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LG-LRCL001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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