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.
Primary Objectives:
- To evaluate the safety and tolerability of LYL845 in participants with R/R metastatic or locally advanced melanoma and selected solid tumors
- To determine the RP2DR of LYL845
Secondary Objectives:
- To evaluate the antitumor activity of LYL845
Exploratory Objectives:
- To measure the expansion of LYL845 in participants
- To evaluate the phenotype of T cells in LYL845 product and in participants
- To assess the clonal diversity of LYL845, identify clones with high prevalence, and track the clones in participants
- To measure the degree of TMB and evaluate the relationship with LYL845 yield, clonal diversity, and clinical response
- To evaluate the prevalence and phenotype of TIL in participants
- To evaluate the expression of tumor markers associated with immune response and with resistance to immunotherapy
- Rutgers Cancer Institute of New Jersey
- Principal Investigator
- Sarah Weiss MD
- Principal Investigator
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
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
For further information about clinical trials, please contact us at 732-235-7356.