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

EMERGE-201: A Phase 2, Multicenter, Open-label Study of Lurbinectedin Efficacy and Safety in Participants With Advanced or Metastatic Solid Tumors

INTRODUCTION

  • Org Study ID: JZP712-201
  • Secondary ID: N/A
  • NTC ID: NCT05126433
  • Sponsor: Jazz Pharmaceuticals

BRIEF SUMMARY

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

DETAILED DESCRIPTION

This phase 2, multicenter, open-label study is designed to assess the safety and efficacy of lurbinectedin monotherapy in 3 cohorts of participants with high-unmet medical need: advanced (metastatic and/or unresectable) urothelial cancer (UC), large cell neuroendocrine tumor (LCNET) of lung, and a tumor agnostic cohort of participants with homologous recombination deficient (HRD) positive malignancies.

  • Overall Status
    Recruiting
  • Start Date
    March 3, 2022
  • Phase
    Phase 2
  • Study Type
    Interventional

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 Carcinoma
  • Large Cell Neuroendocrine Carcinoma of the Lung
  • Homologous Recombination Deficiency

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 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

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

Facility Status Contact
Facility: Eastern Connecticut Hematology and Oncology
Norwich, Connecticut 06360
United States
Status: Recruiting Contact: N/A
Facility: Icahn School of Medicine at Mount Sinai
New York, New York 10029
United States
Status: Recruiting Contact: N/A
Facility: UPMC Hillman Cancer Center Investigational Drug Service
Pittsburgh, Pennsylvania 15232
United States
Status: Recruiting Contact: N/A
Facility: Bon Secours Hematology and Oncology
Greenville, South Carolina 29607
United States
Status: Recruiting Contact: N/A