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NCT05229588
Lurbinectedin in Patients With Advanced Gastrointestinal Malignancies With DNA Repair Mutations
Phase 2 trial testing Lurbinectedin 4 MG Injection [Zepzelca] in Gastrointestinal Malignancies in 8 participants. Completed in 4 August 2025.
4 August 2025
Quick facts
| Lead sponsor | HonorHealth Research Institute |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 8 |
| Start date | 14 June 2022 |
| Primary completion | 4 August 2025 |
| Estimated completion | 4 August 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Lurbinectedin 4 MG Injection [Zepzelca] — full drug profile →
Conditions studied
- Gastrointestinal Malignancies — all drugs for Gastrointestinal Malignancies →
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):
-
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 -
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 -
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 -
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:
- PubMed search for NCT05229588
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Lurbinectedin 4 MG Injection [Zepzelca]
Trials testing the same drug.
- NCT07121478 — Patients With High-grade Pancreatic Neuroendocrine Tumors · Phase 2 · enrolling by invitation
Other recruiting trials for Gastrointestinal Malignancies
Currently open trials in the same condition.
- NCT06644274 — The Value of 68Ga-grazytracer PET in Monitoring Responses to Immunotherapy of Gastrointestinal Malignancies · recruiting
Other HonorHealth Research Institute trials
Trials by the same sponsor.
- NCT05216120 — Pemigatinib in Subjects With Adenosquamous Carcinoma of the Pancreas · Phase 2 · withdrawn
- NCT05004025 — Single Arm Trial of Tumor-Treating Fields in Combination With Nivolumab and Ipilimumab in Metastatic Uveal Melanoma · Phase 1 · completed
- NCT04611139 — Pilot Trial of SP-2577 Plus Pembrolizumab in Select Gynecologic Cancers · Phase 1 · withdrawn
- NCT05175521 — Inhaled IAV vs Inhaled Eucalyptus for the Treatment of Nausea With Acute Migraine · NA · completed
- NCT05068752 — Phase II Trial of Vemurafenib and Sorafenib in Pancreatic Cancer · Phase 2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05229588 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by HonorHealth Research Institute
- Last refreshed: 15 August 2025
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