Lurbinectedin Monotherapy in Participants With Advanced or Metastatic Solid Tumors
Trial ID or NCT#
Status
Purpose
This is an open-label, multicenter, phase 2 study of lurbinectedin monotherapy in participants with advanced (metastatic and/or unresectable) solid tumors.
Official Title
EMERGE-201: A Phase 2, Multicenter, Open-label Study of Lurbinectedin Efficacy and Safety in Participants With Advanced or Metastatic Solid Tumors
Eligibility Criteria
- 1. Signed informed consent 2. ≥ 18 years of age 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 4. Adequate organ and bone marrow function 5. Has measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. 6. Have advanced (metastatic/unresectable) cancers in one of the following: 1. Histologically or cytologically confirmed urothelial cancer 2. Histologically or cytologically confirmed poorly differentiated neuroendocrine carcinoma 3. 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 7. Adequate contraceptive precautions
- 1. Known symptomatic central nervous system (CNS) metastasis requiring steroids 2. History of prior malignancy within 2 years of enrollment 3. Clinically significant cardiovascular disease 4. Active infection requiring systemic therapy 5. Significant non-neoplastic liver disease 6. Prior treatment with trabectedin or lurbinectedin 7. Treatment with an investigational agent within 4 weeks of enrollment 8. Received live vaccine with 4 weeks of first dose 9. Prior allogeneic bone marrow or solid organ transplant 10. Positive hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening 11. Positive human immunodeficiency virus (HIV) infection at screening
Investigator(s)
Contact us to find out if this trial is right for you.
Contact
Paige Nicole Baker
650-736-3687
View on ClinicalTrials.gov