A Study to Investigate LYL845 in Adults With Solid Tumors
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| ClinicalTrials.gov Identifier: NCT05573035 |
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Recruitment Status :
Recruiting
First Posted : October 10, 2022
Last Update Posted : January 24, 2024
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Sponsor:
Lyell Immunopharma, Inc.
Information provided by (Responsible Party):
Lyell Immunopharma, Inc.
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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 |
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 (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 |
| Actual Study Start Date : | December 19, 2022 |
| Estimated Primary Completion Date : | August 2025 |
| Estimated Study Completion Date : | September 2027 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Experimental LYL845
Epigenetically reprogrammed tumor infiltrating lymphocyte (TIL) therapy
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Biological: LYL845
LYL845 is an autologous tumor infiltrating lymphocyte (TIL) enhanced via Epi-R, a proprietary epigenetic reprogramming technology |
Primary Outcome Measures :
- Incidence of dose-limiting toxicities (DLTs) [ Time Frame: Up to 28 days ]Evaluate incidence of dose-limiting toxicities (DLTs)
- Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: Up to 2 years ]Evaluate incidence of treatment-emergent adverse events (TEAEs)
- Severity of treatment-emergent adverse events (TEAEs) [ Time Frame: Up to 2 years ]Evaluate severity of treatment-emergent adverse events (TEAEs)
- 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 :
- 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
- Duration of response (DOR) [ Time Frame: up to 2 years ]Evaluate duration of response (DOR)
- Progression-free survival (PFS) [ Time Frame: up to 2 years ]Evaluate progression-free survival (PFS)
- Overall survival (OS) [ Time Frame: up to 2 years ]Evaluate overall survival (OS)
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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)
- 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
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
| Contact: Lauren Levine, MD | 888-707-7917 | clinicaltrials@lyell.com |
Locations
| United States, California | |
| UC Davis Coomprehensive Cancer Center | Recruiting |
| Sacramento, California, United States, 95817 | |
| Contact: Laura Molnar 916-734-3089 | |
| Principal Investigator: Naseem Esteghamat, MD | |
| UCLA Medical Center | Recruiting |
| Santa Monica, California, United States, 90404 | |
| Contact: J. Randolph Hecht, MD | |
| Contact: Chris Hannigan CHannigan@mednet.ucla.edu | |
| United States, Connecticut | |
| Yale Cancer Center, Yale University | Recruiting |
| New Haven, Connecticut, United States, 06511 | |
| Contact: Michael Hurwitz, MD, PhD michael.hurwitz@yale.edu | |
| Contact: Jialing Zhang jialing.zhang@yale.edu | |
| United States, District of Columbia | |
| Georgetown University | Recruiting |
| Washington, District of Columbia, United States, 20007 | |
| Contact: Geoffrey Gibney, MD | |
| Contact: Stephanie Wagner 202-687-9782 sw1095@georgetown.edu | |
| United States, Iowa | |
| University of Iowa Hospitals and Clinics | Recruiting |
| Iowa City, Iowa, United States, 52242 | |
| Contact: Asad Javed, MD 319-356-4200 | |
| United States, Massachusetts | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Donald Lawrence, MD dplawrence@mgh.harvard.edu | |
| United States, New Jersey | |
| Hackensack Meridian Health Inc | Recruiting |
| Hackensack, New Jersey, United States, 07601 | |
| Contact: Martin Gutierrez, MD 551-996-5499 | |
| Contact: Celina Joco celina.joco@hmhn.org | |
| Rutgers Cancer Institute of New Jersey | Recruiting |
| New Brunswick, New Jersey, United States, 08901 | |
| Contact: Sarah Weiss saweiss@cinj.rutgers.edu | |
| Contact: Xiaoru Chen xc194@cinj.rutgers.edu | |
| United States, North Carolina | |
| Duke University Medical Center | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Brent Hanks, MD | |
| Contact: CCI Clinical Trials Office (919) 681-6468 CCI-TrialReferrals@duke.edu | |
| United States, Ohio | |
| Ohio State University Medical Center | Recruiting |
| Columbus, Ohio, United States, 43210 | |
| Contact: Cara Dauch Cara.dauch@osumc.edu | |
| Contact: Joal Beane, MD | |
| United States, Oregon | |
| Oregon Health Sciences University | Recruiting |
| Portland, Oregon, United States, 97239 | |
| Contact: Clinical Trials Line 503-494-1080 trials@ohsu.edu | |
| Principal Investigator: Robert Eil | |
| United States, Pennsylvania | |
| Allegheny General Hospital | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15212 | |
| Contact: Yazan Samhouri, MD 412-330-6151 clinicaltrials@ahn.org | |
| United States, Texas | |
| University of Texas Southwestern Medical Center | Recruiting |
| Dallas, Texas, United States, 75235 | |
| Contact: Sanjay Chandrasekaran, MD Sanjay.Chandrasekaran@UTSouthwestern.edu | |
| United States, Utah | |
| Huntsman Cancer Institute at University of Utah | Recruiting |
| Salt Lake City, Utah, United States, 84112 | |
| Contact: John Hyngstrom, MD | |
| Contact: Kaitlin Stephens 801-213-8494 | |
| United States, Washington | |
| Fred Hutchinson Cancer Center | Recruiting |
| Seattle, Washington, United States, 98109 | |
| Contact: Fred Hutch Intake 206-606-1024 | |
Sponsors and Collaborators
Lyell Immunopharma, Inc.
| 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: | January 24, 2024 |
| Last Verified: | January 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Lyell Immunopharma, Inc.:
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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 Skin Neoplasms Skin Diseases |