Lurbinectedin Monotherapy in Participants With Advanced or Metastatic Solid Tumors

Phase 2TerminatedNCT05126433

Jazz Pharmaceuticals47 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Interventions

LurbinectedinDRUG

Lurbinectedin 3.2 mg/m\^2 intravenous (IV) every 3 weeks (Q3W)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (17)

Stanford Cancer Center

Stanford, California, United States

Eastern Connecticut Hematology and Oncology

Norwich, Connecticut, United States

Outcomes

Primary Outcomes

Investigator-Assessed Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1

The ORR is defined as the proportion of participants whose best overall response (BOR) is investigator-assessed confirmed complete response (CR) or partial response (PR) using the RECIST v1.1 criteria. BOR is defined as the best response recorded between the date of first dose and the date of objectively documented progression per RECIST v1.1, or the date of subsequent anticancer therapy, death due to any cause, loss to follow-up, or study discontinuation, whichever occurs first.

Time frame: Baseline to disease progression or death, up to 36 weeks.

Secondary Outcomes

Investigator-Assessed Progression Free Survival (PFS) as Assessed Per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1

PFS is defined as the time from the first dosing date to the date of first documented disease progression or death due to any cause, whichever occurs first.

Time frame: Baseline to disease progression or death, up to 36 weeks

Investigator-Assessed Time-To-Response (TTR) as Assessed Per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1

TTR is defined as the time from the first dosing date to the date of the first confirmed response (complete response \[CR\] or partial response \[PR\]), as assessed by the investigators.

Time frame: Baseline to disease progression or death, up to 36 weeks

Investigator-Assessed Duration of Response (DOR) as Assessed Per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1

DOR is defined as the time from the first confirmed response (complete response \[CR\] or partial response \[PR\]) to the date of the first documented tumor progression as determined using RECIST v1.1 criteria or death due to any cause, whichever occurs first

Time frame: Baseline to disease progression or death, up to 36 weeks

Data from ClinicalTrials.gov

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