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Clinical Trial 21698

Cancer Type: Multiple
Study Type: Treatment
NCT#: NCT05126433

Phase: Phase II
Principal Investigator: Shafique, Michael

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Overview

Study Title

A Phase 2, Multicenter, Open-Label Study of Lurbinectedin Efficacy and Safety in Participants with Advanced or Metastatic Solid Tumors

Summary

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

Objective

Primary * To evaluate the antitumor activity of lurbinectedin in the selected advanced solid tumors Secondary * To evaluate the overall safety profile of lurbinectedin in the selected advanced solid tumors * To assess other antitumor efficacy parameters of lurbinectedin in the selected advanced solid tumors. * To assess OS in participants treated with lurbinectedin in the selected advanced solid tumors.

Treatments

Therapies

Chemotherapy (NOS); Therapy (NOS)

Medications

Dexamethasone (); Metoclopramide (); Ondansetron (); PM01183 (lurbinectedin); Zofran (Ondansetron); lurbinectedin ()

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 large cell neuroendocrine tumor of lung
  • 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
  • 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

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