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

NCT07566897 | Not Yet Recruiting Phase 1 DMC

• 2 other identifiers: PH-L19IL2CORK-01/252025-522243-17-00
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreatic Adenocarcinoma Metastatic; Pancreatic Adenocarcinoma; Metastatic Colorectal Carcinoma (mCRC); Renal Carcinoma Metastatic

Keywords

Ruxolitinib; Advanced solid tumors

Outcome Measures

Primary Outcomes (4)

• STEP A and STEP B: DLT

  Occurrence of Dose Limiting Toxicity (DLT) of L19IL2 alone and in combination with ruxolitinib

  From Day 1 to Day 28 of the treatment

• Safety (AE)

  Adverse Events (AEs) of administration of L19IL2 alone and in combination with ruxolitinib, assessed by Common Toxicity Criteria (version 5.0, CTCAE)

  Through study completion, an average of 1 year

• Safety (SAEs)

  Serious Adverse Events(SAEs) of administration of L19IL2 alone and in combination with ruxolitinib, assessed by Common Toxicity Criteria (version 5.0, CTCAE)

  Through study completion, an average of 1 year

• Safety (DILI)

  Evaluation of possible Drug Induce Liver Injury (DILI), caused by L19IL2 alone and in combination with ruxolitinib, assessed by Common Toxicity Criteria (version 5.0, CTCAE)

  Through study completion, an average of 1 year

Secondary Outcomes (9)

• Overall Response Rate (ORR)

  Every 8 weeks from treatment start (every 2 cycles; each cycle is 28 days)

• Disease Control Rate (DCR)

  Every 8 weeks from treatment start (every 2 cycles; each cycle is 28 days)

• DoR

  Every 8 weeks from treatment start (every 2 cycles; each cycle is 28 days)

• PSF

  Every 8 weeks from treatment start (every 2 cycles; each cycle is 28 days)

• Human anti-fusion protein antibody (HAFA)

  Day 1 and 8 of cycle 1; Day 1 of cycle 2, 3, 4, 5, 6. Each cycle is 28 days.

Study Arms (3)

Experimental L19IL2 dose escalation intravenous administration

EXPERIMENTAL

Drug: L19IL2

Experimental L19IL2 + Ruxolitinib dose escalation intravenous administration

EXPERIMENTAL

Drug: L19IL2; Drug: Ruxolitinib

Experimental L19IL2 + Ruxolitinib dose expansion intravenous administration

EXPERIMENTAL

Drug: L19IL2; Drug: Ruxolitinib

Interventions

L19IL2 DRUG

Intravenous administration

Experimental L19IL2 + Ruxolitinib dose escalation intravenous administration; Experimental L19IL2 + Ruxolitinib dose expansion intravenous administration; Experimental L19IL2 dose escalation intravenous administration

Ruxolitinib DRUG

10 mg twice, oral administration

Experimental L19IL2 + Ruxolitinib dose escalation intravenous administration; Experimental L19IL2 + Ruxolitinib dose expansion intravenous administration

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed diagnosis of one of the following tumor types for which no further approved systemic treatment options are available:
• Unresectable locally advanced or metastatic pancreatic ductal adenocarcinoma, that has progressed following:
• 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
• Metastatic proficient mismatch repair / microsatellite stable (pMMR/MSS), BRAF V600E-negative colorectal adenocarcinoma, that has progressed following:
• 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;
• Metastatic clear cell renal cell carcinoma, that has progressed following:
• at least one prior PD-(L)1-based systemic regimen, and
• at least one VEGF-targeted tyrosine kinase inhibitor (TKI), or where these treatments are not suitable due to contraindication or prior intolerance
• Patients must have no further approved and available therapy options or be documented as ineligible or intolerant.
• Patients must have radiographic disease progression on/after the last line of prior treatment.
• At least one unidimensionally measurable lesion as defined by RECIST v.1.1.
• Eastern cooperative oncology group (ECOG) performance status ≤ 2.
• Patient has an estimated life expectancy of at least 12 weeks.

You may not qualify if:

• 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.
• Presence of active severe bacterial or viral infections or other severe concurrent disease, which, in the opinion of the investigator, would place the patient at undue risk or interfere with the study.
• Impaired cardiocirculatory functions due to any of the following conditions:
• a History within the last year of acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris.
• b Inadequately controlled cardiac arrhythmias including atrial fibrillation. c Heart insufficiency (\> Grade II, New York Heart Association (NYHA) criteria). d Any abnormalities observed during baseline ECG and Echocardiogram investigations are considered clinically significant by the investigator.
• e Uncontrolled hypertension defined by systolic blood pressure ≥ 140 mmHg and diastolic blood pressure ≥ 90 mmHg.
• f Ischemic peripheral vascular disease (Grade IIb-IV).
• Known arterial aneurysms.
• INR \> 3.
• Known uncontrolled coagulopathy or bleeding disorder, if the subject is being treated for coagulopathy or bleeding disorder and has tests within screening limits, he/she may be included.
• Known hepatic cirrhosis or severe pre-existing hepatic impairment (Child-Pugh class B or C).
• Moderate to severe respiratory failure.

Sponsors & Collaborators

• Philogen S.p.A.: lead

Study Sites (1)

Fondazione Policlinico Gemelli Unità di Fase 1: Unità di Farmacologia Clinica

Roma, Roma, 00168, Italy

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

ruxolitinib

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Claudio Nanni

CONTACT

+39 057717816; regulatory@philogen.com

Federica Bastioli

CONTACT

+39 057717816; regulatory@philogen.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: May 5, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): May 1, 2030
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)