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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
  • NCT 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), poorly differentiated neuroendocrine carcinomas (PD-NEC), and a homologous recombination deficient-positive malignancies agnostic cohort.

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

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

CONDITION

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

ELIGIBILITY

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

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: N/A

Email: N/A

LOCATION

Facility Status Contact

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