A Study to Investigate LYL845 in Adults With Solid Tumors

January 22, 2024 updated by: Lyell Immunopharma, Inc.

A Phase 1 Study to Assess the Safety and Efficacy of LYL845 in Adults With Relapsed and/or Refractory Metastatic or Locally Advanced Melanoma and Selected Solid Tumor Malignancies

This is an open-label, multi-center, dose-escalation study with expansion cohorts, designed to evaluate the safety and anti-tumor activity of LYL845, an epigenetically reprogrammed tumor infiltrating lymphocyte (TIL) therapy, in participants with relapsed or refractory (R/R) metastatic or locally advanced melanoma, non-small cell lung cancer (NSCLC), and colorectal cancer (CRC).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is an open-label, multi-center, dose-escalation study with expansion cohorts, designed to evaluate the safety and anti-tumor activity of LYL845, an epigenetically reprogrammed tumor infiltrating lymphocyte (TIL) therapy, in participants with relapsed or refractory (R/R) metastatic or locally advanced melanoma, non-small cell lung cancer (NSCLC), and colorectal cancer (CRC). During the dose-escalation phase of the study (Part A), participants with melanoma will be enrolled. Once a safe recommended Phase 2 dose range (RP2DR) has been established in Part A, enrollment will be expanded (Part B) to include additional participants with melanoma, NSCLC and CRC.

Study Type

Interventional

Enrollment (Estimated)

108

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95817
        • Recruiting
        • UC Davis Coomprehensive Cancer Center
        • Contact:
          • Laura Molnar
          • Phone Number: 916-734-3089
        • Principal Investigator:
          • Naseem Esteghamat, MD
      • Santa Monica, California, United States, 90404
    • Connecticut
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Recruiting
        • Georgetown University
        • Contact:
          • Geoffrey Gibney, MD
        • Contact:
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa Hospitals and Clinics
        • Contact:
          • Asad Javed, MD
          • Phone Number: 319-356-4200
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • Hackensack Meridian Health Inc
        • Contact:
          • Martin Gutierrez, MD
          • Phone Number: 551-996-5499
        • Contact:
      • New Brunswick, New Jersey, United States, 08901
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University Medical Center
        • Contact:
          • Brent Hanks, MD
        • Contact:
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Ohio State University Medical Center
        • Contact:
        • Contact:
          • Joal Beane, MD
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health Sciences University
        • Contact:
        • Principal Investigator:
          • Robert Eil
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212
        • Recruiting
        • Allegheny General Hospital
        • Contact:
    • Texas
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • Huntsman Cancer Institute at University of Utah
        • Contact:
          • John Hyngstrom, MD
        • Contact:
          • Kaitlin Stephens
          • Phone Number: 801-213-8494
    • Washington
      • Seattle, Washington, United States, 98109
        • Recruiting
        • Fred Hutchinson Cancer Center
        • Contact:
          • Fred Hutch Intake
          • Phone Number: 206-606-1024

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 18 years up to ≤ 75 years at the time of informed consent
  • Confirmed diagnosis of melanoma, non-small cell lung cancer (NSCLC), or colorectal cancer (CRC) that is metastatic or locally advanced or unresectable and is relapsed and/or refractory (R/R) after standard therapy for each tumor histology
  • Participants must have received prior systemic treatment for their metastatic disease or locally advanced disease based on tumor type as follows:
  • Melanoma: participants with disease progression following an immune checkpoint inhibitor (CPI)
  • NSCLC: participants with disease progression following at least 1 approved systemic therapy, including an immune CPI-containing regimen for appropriate patients or an approved targeted therapy for known molecular abnormalities if applicable to their disease
  • CRC: participants with disease progression following at least 1 line of therapy, including a fluoropyrimidine with oxaliplatin or irinotecan. Microsatellite instability (MSI) high/mismatch repair deficient (dMMR) CRC participants must have disease progression following systemic therapy with immune CPIs.
  • Measurable disease including at least 1 lesion that is safely resectable AND a target lesion to measure response and an additional lesion for biopsy
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate organ and marrow function
  • Women of childbearing potential must have a negative pregnancy test at screening
  • All participants must agree to practice highly effective methods of contraception
  • Fully recovered from toxicity from prior systemic anticancer therapy

Exclusion Criteria:

  • Prior treatment with adoptive cellular therapy
  • Prior solid organ transplantation
  • Central nervous system (CNS) involvement of disease that is extensive, symptomatic or untreated, or patients with leptomeningeal disease
  • Uncontrolled or symptomatic pleural effusion or ascites
  • Untreated or active systemic infection
  • Active autoimmune disease requiring treatment or primary immunodeficiency syndrome
  • Systemic corticosteroids at a dose of >10 mg of prednisone or equivalent per day
  • Other primary malignancy within 3 years prior to enrollment
  • Impaired cardiac function or clinically significant cardiovascular disease
  • Required chronic anticoagulation, such as warfarin, low molecular weight heparin, or Factor Xa inhibitors
  • Pregnant or nursing (lactating) women

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: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental LYL845
Epigenetically reprogrammed tumor infiltrating lymphocyte (TIL) therapy
Biological: LYL845
LYL845 is an autologous tumor infiltrating lymphocyte (TIL) enhanced via Epi-R, a proprietary epigenetic reprogramming technology

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of treatment-emergent adverse events (TEAEs)
Time Frame: Up to 2 years
Evaluate incidence of treatment-emergent adverse events (TEAEs)
Up to 2 years
Severity of treatment-emergent adverse events (TEAEs)
Time Frame: Up to 2 years
Evaluate severity of treatment-emergent adverse events (TEAEs)
Up to 2 years
Determine recommended Phase 2 Dose Range (RP2DR)
Time Frame: Up to 2 years
Determine the recommended Phase 2 dose range (during dose-escalation phase)
Up to 2 years
Incidence of dose-limiting toxicities (DLTs)
Time Frame: Up to 28 days
Evaluate incidence of dose-limiting toxicities (DLTs)
Up to 28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall response rate (ORR) by RECIST, version 1.1
Time Frame: up to 2 years
Evaluate anti-tumor activity of LYL845 based on overall response rate (ORR) by RECIST, version 1.1
up to 2 years
Duration of response (DOR)
Time Frame: up to 2 years
Evaluate duration of response (DOR)
up to 2 years
Progression-free survival (PFS)
Time Frame: up to 2 years
Evaluate progression-free survival (PFS)
up to 2 years
Overall survival (OS)
Time Frame: up to 2 years
Evaluate overall survival (OS)
up to 2 years

Collaborators and Investigators

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

Sponsor

Lyell Immunopharma, Inc.

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 (Actual)

December 19, 2022

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

October 6, 2022

First Submitted That Met QC Criteria

October 6, 2022

First Posted (Actual)

October 10, 2022

Study Record Updates

Last Update Posted (Actual)

January 24, 2024

Last Update Submitted That Met QC Criteria

January 22, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LYL845-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Clinical Trials on Melanoma

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Chile

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe