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 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