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NCT05440942
Combined MEK, STAT3 and PD-1 Inhibition in Metastatic Pancreatic Ductal Adenocarcinoma
Phase 1 trial testing Trametinib in Pancreatic Ductal Adenocarcinoma in 28 participants. Completed in 30 May 2025.
30 May 2025
Quick facts
| Lead sponsor | Peter Hosein, MD |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 28 |
| Start date | 19 January 2023 |
| Primary completion | 30 May 2025 |
| Estimated completion | 30 May 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Trametinib (trametinib) — full drug profile →
- Ruxolitinib (RUXOLITINIB) — full drug profile →
- Retifanlimab (RETIFANLIMAB) — full drug profile →
Conditions studied
- Pancreatic Ductal Adenocarcinoma — all drugs for Pancreatic Ductal Adenocarcinoma →
Sponsor
Peter Hosein, MD — full company profile →
Who can join
18 and older, any sex, with Pancreatic Ductal Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this research is to test whether a combination treatment of Trametinib, Retifanlimab, and Ruxolitinib (TR\^2) will reduce tumor size in patients with metastatic pancreatic ductal adenocarcinoma (PDAC).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Combined MEK and STAT3 Inhibition Uncovers Stromal Plasticity by Enriching for Cancer-Associated Fibroblasts With Mesenchymal Stem Cell-Like Features to Overcome Immunotherapy Resistance in Pancreatic Cancer.
Datta J, Dai X, Bianchi A, De Castro Silva I, et al · · 2022 · cited 128× · PMID 35948109 · DOI 10.1053/j.gastro.2022.07.076 -
Barriers and opportunities in pancreatic cancer immunotherapy.
Ju Y, Xu D, Liao MM, Sun Y, et al · · 2024 · cited 83× · PMID 39266715 · DOI 10.1038/s41698-024-00681-z -
Transcription factors in fibroblast plasticity and CAF heterogeneity.
Melchionna R, Trono P, Di Carlo A, Di Modugno F, et al · · 2023 · cited 46× · PMID 38124183 · DOI 10.1186/s13046-023-02934-4 -
STAT3 Inhibitors: A Novel Insight for Anticancer Therapy of Pancreatic Cancer.
Li X, Jiang W, Dong S, Li W, et al · · 2022 · cited 32× · PMID 36291659 · DOI 10.3390/biom12101450 -
Pancreatic Cancer Treatment Targeting the HGF/c-MET Pathway: The MEK Inhibitor Trametinib.
Kim J, Lee TS, Lee MH, Cho IR, et al · · 2024 · cited 12× · PMID 38473413 · DOI 10.3390/cancers16051056 -
Sex-Related Differences in Pancreatic Ductal Adenocarcinoma Progression and Response to Therapy.
Grahovac J, Đurić A, Tanić M, Krivokuća A. · · 2024 · cited 6× · PMID 39684385 · DOI 10.3390/ijms252312669 -
A STAT3/integrin axis accelerates pancreatic cancer initiation and progression.
Campos AD, Shepard RM, Ortega Z, Heumann I, et al · · 2025 · cited 5× · PMID 40701148 · DOI 10.1016/j.celrep.2025.116010 -
Top advances of the year: Pancreatic cancer.
Warren EAK, Lesinski GB, Maithel SK. · · 2023 · cited 5× · PMID 37776536 · DOI 10.1002/cncr.35031
Verify or expand the search:
- PubMed search for NCT05440942
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Trametinib
Trials testing the same drug.
- NCT05275374 — XP-102 and XP-102 in Combination With Trametinib in Advanced Solid Tumor Patients With a BRAF V600 Mutation · Phase 1, PHASE2 · not yet recruiting
- NCT07110246 — Dabrafenib and Trametinib for BRAF V600 Mutant Low-Grade Gliomas · Phase 2 · recruiting
- NCT07010393 — Genotype-Driven Neoadjuvant Therapy for Locally Advanced Thyroid Cancer: A Real-World Cohort Study · Phase 4 · not yet recruiting
- NCT06962254 — Imatinib and Trametinib for KRAS-mutated Solid Tumor · Phase 1 · recruiting
- NCT06119789 — Precision Cancer Therapy in Rare Cancers · Phase 2 · recruiting
Other recruiting trials for Pancreatic Ductal Adenocarcinoma
Currently open trials in the same condition.
- NCT07324096 — A Screening Program to Improve the Early Detection of Sporadic Pancreatic Cancer in Individuals With a High-Risk of Deve · NA · recruiting
- NCT07432633 — [18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications · Phase 1, PHASE2 · recruiting
- NCT07328607 — Outcomes After Laparoscopic Versus Open Pancreaticoduodenectomy · NA · recruiting
- NCT07232810 — Prognostic Outcomes of Total Mesopancreas Excision for Pancreatic Head Cancer · NA · recruiting
- NCT07261631 — Phase I Study of [177Lu]Lu-DFC413 in Patients With Solid Tumors · Phase 1 · recruiting
Other Peter Hosein, MD trials
Trials by the same sponsor.
- NCT06889493 — SVV-001 With Nivolumab and Ipilimumab in Patients With Poorly Differentiated Neuroendocrine Carcinomas (NEC) or Well-Dif · Phase 1 · recruiting
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 NCT05440942 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 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 Peter Hosein, MD
- Last refreshed: 5 June 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/NCT05440942.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing