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Trial record 1 of 1 for:    LYL845
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A Study to Investigate LYL845 in Adults With Solid Tumors

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ClinicalTrials.gov Identifier: NCT05573035
Recruitment Status : Not yet recruiting
First Posted : October 10, 2022
Last Update Posted : October 14, 2022
Sponsor:
Information provided by (Responsible Party):
Lyell Immunopharma, Inc.

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Melanoma Non-small Cell Lung Cancer Colorectal Cancer Biological: LYL845 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single-arm, open-label, dose-escalation and -expansion study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : December 2022
Estimated Primary Completion Date : August 2025
Estimated Study Completion Date : September 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

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




Primary Outcome Measures :
  1. Incidence of dose-limiting toxicities (DLTs) [ Time Frame: Up to 2 years ]
    Evaluate incidence of dose-limiting toxicities (DLTs)

  2. Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: Up to 2 years ]
    Evaluate incidence of treatment-emergent adverse events (TEAEs)

  3. Severity of treatment-emergent adverse events (TEAEs) [ Time Frame: Up to 2 years ]
    Evaluate severity of treatment-emergent adverse events (TEAEs)

  4. Determine recommended Phase 2 Dose Range (RP2DR) [ Time Frame: Up to 2 years ]
    Determine the recommended Phase 2 dose range (during dose-escalation phase)


Secondary Outcome Measures :
  1. 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

  2. Complete response rate (CR) by RECIST, version 1.1 [ Time Frame: up to 2 years ]
    Evaluate anti-tumor activity of LYL845 based on complete response rate (CR) by RECIST, version 1.1

  3. Duration of response (DOR) [ Time Frame: up to 2 years ]
    Evaluate duration of response (DOR)

  4. Progression-free survival (PFS) [ Time Frame: up to 2 years ]
    Evaluate progression-free survival (PFS)

  5. Overall survival (OS) [ Time Frame: up to 2 years ]
    Evaluate overall survival (OS)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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) and if BRAF-mutated, BRAF/MEK inhibition
  • 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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05573035


Contacts
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Contact: Heidi Gillenwater, MD 888-707-7917 clinicaltrials@lyell.com

Locations
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United States, Ohio
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Contact: Joal Beane, MD         
United States, Oregon
Oregon Health Sciences University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
Contact: Yazan Samhouri, MD    412-330-6151    clinicaltrials@ahn.org   
United States, Utah
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, United States, 84112
Contact: John Hyngstrom, MD    801-581-4477      
Sponsors and Collaborators
Lyell Immunopharma, Inc.
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Responsible Party: Lyell Immunopharma, Inc.
ClinicalTrials.gov Identifier: NCT05573035    
Other Study ID Numbers: LYL845-101
First Posted: October 10, 2022    Key Record Dates
Last Update Posted: October 14, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lyell Immunopharma, Inc.:
TIL
tumor infiltrating lymphocyte
melanoma
non-small cell lung cancer
colorectal cancer
NSCLC
CRC
relapsed
refractory
locally advanced
advanced
metastatic
epigenetic
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Melanoma
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas