A Study to Investigate LYL845 in Adults With Solid Tumors

L

Lyell Immunopharma

Status and phase

Enrolling
Phase 1

Conditions

Melanoma
Non-small Cell Lung Cancer
Colorectal Cancer

Treatments

Biological: LYL845

Study type

Interventional

Funder types

Industry

Identifiers

NCT05573035
LYL845-101

Details and patient eligibility

About

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).

Full 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.

Enrollment

108 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

108 participants in 1 patient group

Experimental LYL845
Experimental group
Description:
Epigenetically reprogrammed tumor infiltrating lymphocyte (TIL) therapy
Treatment:
Biological: LYL845

Trial contacts and locations

0

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Central trial contact

Lauren Levine, MD

Data sourced from clinicaltrials.gov

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