Breast Cancer Clinical Trial
Lurbinectedin Monotherapy in Participants With Advanced or Metastatic Solid Tumors
Summary
This is an open-label, multicenter, phase 2 study of lurbinectedin monotherapy in participants with advanced (metastatic and/or unresectable) solid tumors.
Full Description
This phase 2, multicenter, open-label study is designed to assess the safety and efficacy of lurbinectedin monotherapy in 3 cohorts of participants with high-unmet medical need: advanced (metastatic and/or unresectable) urothelial cancer (UC), large cell neuroendocrine tumor (LCNET) of lung, and a tumor agnostic cohort of participants with homologous recombination deficient (HRD) positive malignancies.
Eligibility Criteria
Inclusion Criteria:
Signed informed consent
≥ 18 years of age
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Adequate organ and bone marrow function
Has measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Have advanced (metastatic/unresectable) cancers in one of the following:
Histologically or cytologically confirmed urothelial cancer
Histologically or cytologically confirmed large cell neuroendocrine tumor of lung
Histologically or cytologically confirmed homologous recombination deficient (HRD) positive endometrial, biliary tract, urothelial, breast (TNBC or HR+HER2- breast cancer), pancreas, gastric, or esophageal solid tumors with preidentified germline and/or somatic pathogenic mutation
Adequate contraceptive precautions
Exclusion Criteria:
Known symptomatic central nervous system (CNS) metastasis requiring steroids
History of prior malignancy within 2 years of enrollment
Clinically significant cardiovascular disease
Active infection requiring systemic therapy
Significant non-neoplastic liver disease
Prior treatment with trabectedin or lurbinectedin
Treatment with an investigational agent within 4 weeks of enrollment
Received live vaccine with 4 weeks of first dose
Prior allogeneic bone marrow or solid organ transplant
Positive hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening
Positive human immunodeficiency virus (HIV) infection at screening
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There are 13 Locations for this study
Norwich Connecticut, 06360, United States
Saint Petersburg Florida, 33705, United States
Pikeville Kentucky, 41501, United States
Boston Massachusetts, 02215, United States
Omaha Nebraska, 68124, United States
New York New York, 10029, United States
Charlotte North Carolina, 28203, United States
Columbus Ohio, 43219, United States
Philadelphia Pennsylvania, 19104, United States
Pittsburgh Pennsylvania, 15232, United States
Greenville South Carolina, 29607, United States
Nashville Tennessee, 37203, United States
Houston Texas, 77030, United States
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