Lurbinectedin Monotherapy in Participants With Advanced or Metastatic Solid Tumors (EMERGE-201)

Trial ID or NCT#

NCT05126433

Status

not recruiting iconNOT RECRUITING

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

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. 1. Signed informed consent2. ≥ 18 years of age3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 14. Adequate organ and bone marrow function5. Has measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.6. Have advanced (metastatic/unresectable) cancers in one of the following:
  2. 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 mutation7. Adequate contraceptive precautions
Exclusion Criteria:
  1. 1. Known symptomatic central nervous system (CNS) metastasis requiring steroids2. History of prior malignancy within 2 years of enrollment3. Clinically significant cardiovascular disease4. Active infection requiring systemic therapy5. Significant non-neoplastic liver disease6. Prior treatment with trabectedin or lurbinectedin7. Treatment with an investigational agent within 4 weeks of enrollment8. Received live vaccine with 4 weeks of first dose9. Prior allogeneic bone marrow or solid organ transplant10. Positive hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening11. Positive human immunodeficiency virus (HIV) infection at screening
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Investigator(s)

Sandy Srinivas
Sandy Srinivas
Medical oncologist, Urologic specialist, Genitourinary specialist
Professor of Medicine (Oncology) and, by courtesy, of Urology

Contact us to find out if this trial is right for you.

Contact

Paige Nicole Baker
650-736-3687

View on ClinicalTrials.gov