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NCT05229588

Lurbinectedin in Patients With Advanced Gastrointestinal Malignancies With DNA Repair Mutations

Completed Phase 2 Last updated 15 August 2025
What this trial tests

Phase 2 trial testing Lurbinectedin 4 MG Injection [Zepzelca] in Gastrointestinal Malignancies in 8 participants. Completed in 4 August 2025.

Timeline
14 June 2022
Primary endpoint
4 August 2025
4 August 2025

Quick facts

Lead sponsorHonorHealth Research Institute
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment8
Start date14 June 2022
Primary completion4 August 2025
Estimated completion4 August 2025
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

HonorHealth Research Institute

Who can join

18 and older, any sex, with Gastrointestinal Malignancies. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this research is to evaluate the activity and safety of lurbinectedin in adult patients with advanced Gastrointestinal Malignancies with DNA repair mutations.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Are targeted therapies or immunotherapies effective in metastatic pancreatic adenocarcinoma?
    Rémond MS, Pellat A, Brezault C, Dhooge M, et al · · 2022 · cited 22× · PMID 36399952 · DOI 10.1016/j.esmoop.2022.100638
  2. Marine natural products as a source of novel anticancer drugs: an updated review (2019-2023).
    El-Seedi HR, Refaey MS, Elias N, El-Mallah MF, et al · · 2025 · cited 16× · PMID 39853457 · DOI 10.1007/s13659-024-00493-5
  3. Tumor-associated macrophages (TAMs): Constructing an immunosuppressive microenvironment bridge for pancreatic ductal adenocarcinoma (PDAC).
    Liu R, Li J, Liu L, Wang W, et al · · 2025 · cited 6× · PMID 40458305 · DOI 10.1016/j.cpt.2024.07.004
  4. Innate Immunity and Platelets: Unveiling Their Role in Chronic Pancreatitis and Pancreatic Cancer.
    Blümke J, Schameitat M, Verma A, Limbecker C, et al · · 2025 · cited 2× · PMID 40427186 · DOI 10.3390/cancers17101689

Verify or expand the search:

Other trials of Lurbinectedin 4 MG Injection [Zepzelca]

Trials testing the same drug.

Other recruiting trials for Gastrointestinal Malignancies

Currently open trials in the same condition.

Other HonorHealth Research Institute trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05229588.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing