A Phase I Study to Evaluate the Safety and Efficacy of L19IL2 in Combination With Ruxolitinib in Patients With Advanced Solid Tumors

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorPhilogen S.p.A.

About this trial

This trial aims to address unmet medical needs in advanced solid tumors, specifically metastatic clear cell renal carcinoma, locally advanced or metastatic pancreatic adenocarcinoma, and metastatic colorectal adenocarcinoma.

Eligibility criteria

Qualifiers

at least one prior line containing FOLFIRINOX and/or gemcitabine plus nab-paclitaxel, and

at least one approved second-line regimen (e.g., 5-FU/leucovorin plus liposomal irinotecan), or where these regimens are not suitable due to contraindication or prior intolerance

at least one prior line of systemic therapy including a fluoropyrimidine and oxaliplatin or irinotecan, with or without anti-VEGF and, if RAS wild-type, with or without anti-EGFR, and

at least one approved subsequent line of therapy with trifluridine-tipiracil, regorafenib or fruquintinib, or where these agents are not suitable due to contraindication or prior intolerance;

Disqualifiers

Patients with primary brain tumors, brain metastases or CNS disease will be excluded.

Chemotherapy, immunotherapy, or radiation therapy at the tumor sites within 4 weeks prior to study treatment start.

Active or history of autoimmune disease that might deteriorate when receiving an immunostimulatory agent.

Previous or concurrent cancer type that is distinct from the cancer being evaluated in this study. Exception made for any other cancer curatively treated ≥ 2 years prior to study treatment start.

Trial design

Treatments tested in this trial

  • L19IL2
  • Ruxolitinib

Treatment groups

96 Participants
are divided into 3 treatment groups

Sponsors and collaborators