A Study to Investigate LYL845 in Adults With Solid Tumors (NCT05573035) | Clinical Trial Compass
TerminatedPhase 1
A Study to Investigate LYL845 in Adults With Solid Tumors
Stopped: Pipeline Reprioritization
United States39 participantsStarted 2022-12-19
Plain-language 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).
Who can participate
Age range18 Years – 75 Years
SexALL
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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 participan…
What they're measuring
1
Incidence of dose-limiting toxicities (DLTs)
Timeframe: Up to 28 days
2
Incidence of treatment-emergent adverse events (TEAEs)
Timeframe: Up to 2 years
3
Severity of treatment-emergent adverse events (TEAEs)