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

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

Find similar trials in Stanford, CA

Related Studies

• Evaluation of Non-Invasive Assays for the Detection of Urothelial Cancer
  Recruiting · Lahey Clinic · Burlington, Massachusetts
• A Study of Tulmimetostat DZR123 (CPI-0209) in Patients With Advanced Solid Tumors and Lymphomas
  PHASE1/PHASE2 · Recruiting · Novartis Pharmaceuticals · Atlanta, Georgia
• Anti-PD-1 mAb Plus Metabolic Modulator in Solid Tumor Malignancies
  PHASE2 · Recruiting · Dan Zandberg · Pittsburgh, Pennsylvania
• Study of Ifinatamab Deruxtecan (DS-7300a, I-DXd) in Participants With Advanced Solid Malignant Tumors
  PHASE1/PHASE2 · Recruiting · Daiichi Sankyo · Los Angeles, California