Lurbinectedin Monotherapy in Participants With Advanced or Metastatic Solid Tumors

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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

Key Dates

First listed

Nov 19, 2021

Start date

Mar 3, 2022

Status verified

Feb 2025

Primary completion

Dec 20, 2023

Completion

Dec 20, 2023

Study Design

Enrollment

47 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Urothelial Cancer Cohort
  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.
• Experimental: Poorly Differentiated Neuroendocrine Carcinomas Cohort
  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.
• Experimental: Homologous Recombination Deficient-Positive Malignancies Agnostic Cohort
  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.

Primary Outcome Measure

Investigator-Assessed Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 [ Time Frame: Baseline to disease progression or death, up to 36 weeks. ]

Locations (17)

Related coverage on Hipa.ai

• Lurbinectedin Monotherapy Shows Limited ORR in Advanced Solid Tumors
  Lurbinectedin · Feb 28, 2025 · ClinicalTrials.gov

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