A Study to Investigate LYL845 in Adults With Solid Tumors

About

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).

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase I

Eligibility

Gender

All

Healthy Volunteers

Minimum Age

18 Years

Maximum Age

75 Years

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

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