This is a first in human, single arm, open label, Phase 1a/1b study to determine the safety, feasibility, and efficacy of a single dose of NeoTCR-P1 T cells in participants with solid tumors.
Histologically or cytologically documented incurable or metastatic solid tumors of the following types: melanoma, UC, ovarian cancer, colorectal cancer, breast cancer (HR+), or prostate cancer. Disease has progressed after at least one available standard therapy or no additional curative therapies are available. Measurable disease per RECIST v1.1 Eastern cooperative oncology group (ECOG) performance status of 0 or 1 Adequate hematologic and end organ function determined within 30 days prior to enrollment. Disease-specific criteria related to the specific tumor type are required.
Note: There are additional inclusion criteria. The study center will determine if you meet all of the criteria.
Exclusion Criteria:
Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, cirrhosis, and/or inherited liver disease Known primary central nervous system (CNS) malignancy or symptomatic CNS metastases Uncontrolled or symptomatic hypercalcemia Pregnancy, lactation, or breastfeeding Prior allogeneic stem cell transplant or solid organ transplant Prior chimeric antigen receptor therapy or other genetically modified T cell therapy Active HIV, Hepatitis B, or Hepatitis C infection Active tuberculosis Severe infection within 2 weeks prior to enrollment Major surgical procedure within 4 weeks prior to enrollment or anticipation of need for a major surgical procedure during the study.
Note: There are additional exclusion criteria. The study center will determine if you meet all of the criteria.
