EMERGE-201: A Phase 2, Multicenter, Open-label Study of Lurbinectedin Efficacy and Safety in Participants With Advanced or Metastatic Solid Tumors

JZP712-201

This is an open-label, multicenter, phase 2 study of lurbinectedin monotherapy in participants with advanced (metastatic and/or unresectable) solid tumors.

2022-03-03

2023-12-20

2023-12-20

Completed

Early phase I

47

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 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 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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 47, 'type': 'ACTUAL'}}

2024-02-26