Brief Title: Lurbinectedin Monotherapy in Participants With Advanced or Metastatic Solid Tumors

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Investigator-Assessed Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1

Primary Outcome 1 - Timeframe: Baseline to disease progression or death, up to 36 weeks.

CONDITION

• Advanced Solid Tumor
• Metastatic Solid Tumor
• Urothelial Cancer
• Poorly Differentiated Neuroendocrine Carcinomas
• Homologous Recombination Deficient-Positive Malignancies Agnostic

ELIGIBILITY

Inclusion Criteria:
Signed informed consent

- ≥ 18 years of age

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

- Adequate organ and bone marrow function

- Has measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Have advanced (metastatic/unresectable) cancers in one of the following:
Histologically or cytologically confirmed urothelial cancer

- Histologically or cytologically confirmed poorly differentiated neuroendocrine carcinoma

- 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

- Adequate contraceptive precautions
Exclusion Criteria:
Known symptomatic central nervous system (CNS) metastasis requiring steroids

- History of prior malignancy within 2 years of enrollment

- Clinically significant cardiovascular disease

- Active infection requiring systemic therapy

- Significant non-neoplastic liver disease

- Prior treatment with trabectedin or lurbinectedin

- Treatment with an investigational agent within 4 weeks of enrollment

- Received live vaccine with 4 weeks of first dose

- Prior allogeneic bone marrow or solid organ transplant

- Positive hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening

- Positive human immunodeficiency virus (HIV) infection at screening

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact

Name: N/A

Phone: 215-832-3750

Email: ClinicalTrialDisclosure@JazzPharma.com

LOCATION