Lurbinectedin Monotherapy in Participants With Advanced or Metastatic Solid Tumors

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 poorly differentiated neuroendocrine carcinoma
• Histologically or cytologically confirmed homologous recombination deficient-positive malignancies agnostic, which may include 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