Lurbinectedin Monotherapy in Participants With Advanced or Metastatic Solid Tumors

Not Recruiting

Trial ID: NCT05126433


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

Stanford Investigator(s)

Sandy Srinivas
Sandy Srinivas

Professor of Medicine (Oncology) and, by courtesy, of Urology


Inclusion 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

      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

   7. Adequate contraceptive precautions

Exclusion Criteria:

   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


drug: Lurbinectedin

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Paige Nicole Baker

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