Clinical trial NCT05126433: Lurbinectedin Monotherapy in Participants With Advanced or Metastatic Solid Tumors
Official title: EMERGE-201: A Phase 2, Multicenter, Open-label Study of Lurbinectedin Efficacy and Safety in Participants With Advanced or Metastatic Solid Tumors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Advanced Solid Tumor
Metastatic Solid Tumor
Urothelial Cancer
Poorly Differentiated Neuroendocrine Carcinomas
Homologous Recombination Deficient-Positive Malignancies Agnostic
Keywords: Lurbinectedin
Monotherapy
Urothelial cancer
Poorly differentiated neuroendocrine carcinomas
Homologous recombination deficient-positive malignancies agnostic
Lead sponsor: Jazz Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Jazz Pharmaceuticals Ireland Limited
First posted: 2021-11-19
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Investigator-Assessed Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1
timeFrame: Baseline to disease progression or death, up to 36 weeks.
Secondary outcomes:
measure: Investigator-Assessed Progression Free Survival (PFS) as Assessed Per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1
timeFrame: Baseline to disease progression or death, up to 36 weeks
measure: Investigator-Assessed Time-To-Response (TTR) as Assessed Per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1
timeFrame: Baseline to disease progression or death, up to 36 weeks
measure: Investigator-Assessed Duration of Response (DOR) as Assessed Per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1
timeFrame: Baseline to disease progression or death, up to 36 weeks
measure: Investigator-assessed Disease Control Rate (DCR) as Assessed Per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1
timeFrame: Baseline to disease progression or death, up to 36 weeks.
measure: Overall Survival (OS) in Participants Treated With Lurbinectedin
timeFrame: Baseline and every 3 months, up to 16 months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Cancer Center
state: California
city: Norwich
country: United States
facility: Eastern Connecticut Hematology and Oncology
state: Connecticut
city: Fort Myers
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Saint Petersburg
country: United States
facility: Sarah Cannon, Florida Cancer Specialist
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Pikeville
country: United States
facility: Pikeville Medical Center
state: Kentucky
city: Boston
country: United States
facility: Dana Farber
state: Massachusetts
city: Omaha
country: United States
facility: Oncology Hematology West, PC dba Nebraska Cancer Specialists
state: Nebraska
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Charlotte
country: United States
facility: Levine Cancer Institute
state: North Carolina
city: Columbus
country: United States
facility: Sarah Cannon, Zangmeister Cancer Center
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Center Investigational Drug Service
state: Pennsylvania
city: Greenville
country: United States
facility: Bon Secours Hematology and Oncology
state: South Carolina
city: Nashville
country: United States
facility: Sarah Cannon, Tennesse Oncology
state: Tennessee
city: Houston
country: United States
facility: MD Anderson
state: Texas
city: Fairfax
country: United States
facility: Inova Schar Cancer Institute
state: Virginia
Study officials:
References: