Lurbinectedin Monotherapy in Participants With Advanced or Metastatic Solid Tumors
Study Phase: Phase 2
Recruitment Status: Recruiting
Start Date: February 28, 2022
End Date: June 23, 2024
Clinical Trial Disclosure & Transparency
215-832-3750
215-832-3750
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
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Conditions:
- Neoplasms
- Carcinoma, Neuroendocrine