Lurbinectedin Monotherapy in Participants With Advanced or Metastatic Solid Tumors

ID#: NCT05126433

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 2

Recruitment Status: Recruiting

Start Date: February 28, 2022

End Date: June 23, 2024

Contact Information:
Clinical Trial Disclosure & Transparency
Summary: This is an open-label, multicenter, phase 2 study of lurbinectedin monotherapy in participants with advanced (metastatic and/or unresectable) solid tumors.

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 large cell neuroendocrine tumor of lung

3. Histologically or cytologically confirmed homologous recombination deficient (HRD) positive 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