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Spots Global Cancer Trial Database for A Study to Investigate LYL845 in Adults With Solid Tumors

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Trial Identification

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

Interventions

LYL845

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

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