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Brief Title: A Study to Investigate LYL845 in Adults With Solid Tumors
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
Study ID: NCT05573035
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).
Detailed 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
UC Davis Coomprehensive Cancer Center, Sacramento, California, United States
UCLA Medical Center, Santa Monica, California, United States
Yale Cancer Center, Yale University, New Haven, Connecticut, United States
Georgetown University, Washington, District of Columbia, United States
University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Hackensack Meridian Health Inc, Hackensack, New Jersey, United States
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
Duke University Medical Center, Durham, North Carolina, United States
Ohio State University Medical Center, Columbus, Ohio, United States
Oregon Health Sciences University, Portland, Oregon, United States
Allegheny General Hospital, Pittsburgh, Pennsylvania, United States
University of Texas Southwestern Medical Center, Dallas, Texas, United States
Huntsman Cancer Institute at University of Utah, Salt Lake City, Utah, United States
Fred Hutchinson Cancer Center, Seattle, Washington, United States