Clinical trial • Phase III • Oncology

Ruxolitinib for Advanced solid tumors | Metastatic clear cell renal cell carcinoma | Colorectal carcinoma (pMMR/MSS, BRAF V600E-negative) | Pancreatic adenocarcinoma (locally advanced or metastatic)

Phase III trial of Ruxolitinib for Advanced solid tumors | Metastatic clear cell renal cell carcinoma | Colorectal carcinoma (pMMR/MSS, BRAF V600E-negativ…

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Advanced solid tumors | Metastatic clear cell renal cell carcinoma | Colorectal carcinoma (pMMR/MSS, BRAF V600E-negative) | Pancreatic adenocarcinoma (locally advanced or metastatic)
Trial Stage
Phase III
Drug Modality
Peptide/protein/enzyme | Small molecule

Key dates

Initial CTIS Submission Date
08-08-2025
First CTIS Authorization Date
22-12-2025

Trial design

Phase III trial across 1 site in Italy.

Target Sample Size
96

Recruitment

Planned Sample Size
96
Recruitment Window Months
43

Geography

Total Number Of Sites
1
Total Number Of Participants
96

Italy

Earliest CTIS Part Ii Submission Date
13-11-2025
Latest Decision Or Authorization Date
20-04-2026
Processing Time Days
158
Number Of Sites
1
Number Of Participants
96

Sites

Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
UOC Phase 1
Contact Person Name
Gennaro Daniele
Number Of Participants
96

Sponsor

Primary sponsor

Full Name
Philogen S.p.A.
Organisation Type
Pharmaceutical company
Country Of Registered Address
Italy

Investigational products

Investigational Product Name
L19IL2
Modality
Peptide/protein/enzyme
Investigational Product Name
Ruxolitinib
Active Substance
Ruxolitinib
Modality
Small molecule
Combination Treatment
Yes

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