Lurbinectedin Monotherapy in Participants With Advanced or Metastatic Solid Tumors

NCT05126433 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: JZP712-201
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 17

Brief Summary

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

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to disease progression or death, up to 36 weeks.

Secondary Outcomes (5)

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

  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

  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

  Baseline to disease progression or death, up to 36 weeks

• Investigator-assessed Disease Control Rate (DCR) as Assessed Per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1

  Baseline to disease progression or death, up to 36 weeks.

• Overall Survival (OS) in Participants Treated With Lurbinectedin

  Baseline and every 3 months, up to 16 months

Study Arms (3)

Urothelial Cancer Cohort

EXPERIMENTAL

Participants with advanced (metastatic and/or unresectable) urothelial carcinoma who have progressed on platinum-containing regimen (prior therapies may include but are not limited to immune checkpoint inhibitor, enformumab vendotin, or sacituzumab govitecan) will receive Lurbinectedin 3.2 mg/m\^2 intravenous (IV) on Day 1 of every 3 weeks (Q3W) cycle until confirmed disease progression, withdrawal of participant consent, participant lost to follow-up, unacceptable toxicity, or the study or individual cohort may be terminated by the sponsor for lack of efficacy signal or any other reason.

Drug: Lurbinectedin

Poorly Differentiated Neuroendocrine Carcinomas Cohort

EXPERIMENTAL

Participants with advanced (metastatic and/or unresectable) poorly differentiated neuroendocrine carcinomas who received at least 1 prior line of therapy will receive Lurbinectedin 3.2 mg/m\^2 intravenous (IV) on Day 1 of every 3 weeks (Q3W) cycle until confirmed disease progression, withdrawal of participant consent, participant lost to follow-up, unacceptable toxicity, or the study or individual cohort may be terminated by the sponsor for lack of efficacy signal or any other reason.

Drug: Lurbinectedin

Homologous Recombination Deficient-Positive Malignancies Agnostic Cohort

EXPERIMENTAL

Participants with advanced (metastatic and/or unresectable) 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 and received at least 1 prior line of therapy will receive Lurbinectedin 3.2 mg/m\^2 intravenous (IV) on Day 1 of every 3 weeks (Q3W) cycle until confirmed disease progression, withdrawal of participant consent, participant lost to follow-up, unacceptable toxicity, or the study or individual cohort may be terminated by the sponsor for lack of efficacy signal or any other reason.

Drug: Lurbinectedin

Interventions

Lurbinectedin DRUG

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

Homologous Recombination Deficient-Positive Malignancies Agnostic Cohort; Poorly Differentiated Neuroendocrine Carcinomas Cohort; Urothelial Cancer Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 poorly differentiated neuroendocrine carcinoma
• 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
• Adequate contraceptive precautions

You may not qualify if:

• 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

Sponsors & Collaborators

• Jazz Pharmaceuticals: lead
• Jazz Pharmaceuticals Ireland Limited: collaborator

Study Sites (17)

Stanford Cancer Center

Stanford, California, 94305, United States

Location

Eastern Connecticut Hematology and Oncology

Norwich, Connecticut, 06360, United States

Location

Florida Cancer Specialists

Fort Myers, Florida, 33901, United States

Location

Sarah Cannon, Florida Cancer Specialist

St. Petersburg, Florida, 33705, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Pikeville Medical Center

Pikeville, Kentucky, 41501, United States

Location

Dana Farber

Boston, Massachusetts, 02215, United States

Location

Oncology Hematology West, PC dba Nebraska Cancer Specialists

Omaha, Nebraska, 68124, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Levine Cancer Institute

Charlotte, North Carolina, 28203, United States

Location

Sarah Cannon, Zangmeister Cancer Center

Columbus, Ohio, 43219, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

UPMC Hillman Cancer Center Investigational Drug Service

Pittsburgh, Pennsylvania, 15232, United States

Location

Bon Secours Hematology and Oncology

Greenville, South Carolina, 29607, United States

Location

Sarah Cannon, Tennesse Oncology

Nashville, Tennessee, 37203, United States

Location

MD Anderson

Houston, Texas, 77030, United States

Location

Inova Schar Cancer Institute

Fairfax, Virginia, 22031, United States

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

PM 01183

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Clinical Trial Disclosure & Transparency
• Organization: Jazz Pharmaceuticals Inc.

ClinicalTrialDisclosure@JazzPharma.com

215-832-3750

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2021
• First Posted: November 19, 2021
• Study Start: March 3, 2022
• Primary Completion: December 20, 2023
• Study Completion: December 20, 2023
• Last Updated: February 28, 2025
• Results First Posted: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share

Locations

US (17)