Renal Carcinoma MetastaticPhase 1NCT07566897
A Phase I Study to Evaluate the Safety and Efficacy of L19IL2 in Combination With Ruxolitinib in Patients With Advanced Solid Tumors
A Phase 1 study testing L19IL2 and Ruxolitinib in people with Renal Carcinoma Metastatic and Pancreatic Adenocarcinoma Metastatic, run by Philogen S.p.A. at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Renal Carcinoma Metastatic, Pancreatic Adenocarcinoma Metastatic, Pancreatic Adenocarcinoma
- What is being tested?
- L19IL2 and Ruxolitinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2026to May 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
- Hemoglobin > 10.0 g/dL.
- Platelets ≥ 100 x 109/L.
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L.
- Negative TB test (e.g., Mantoux or Quantiferon assay).
- Documented negative test for HIV, HBV, HCV excluding active infection is needed. For HBV serology: the determination of HBsAg and anti-HBcAg-Ab is required. In patients with serology documenting previous exposure to HBV (i.e., anti-HBs Ab with no history of vaccination and/or anti-HBc Ab), negative serum HBV-DNA is required. For HCV: HCV-RNA or HCV antibody test. Subjects with a positive test for HCV antibody but no detection of HCV-RNA indicating no current infection are eligible.
- Serum creatinine < 1.5 x ULN and estimated Glomerular Filtration Rate (eGFR) value above 75 mL/min/1.73m2. An age-calibrated definition of Chronic Kidney Disease (CKD) has been proposed to distinguish age-related from disease-related changes in eGFR. For patients younger than 40 years, CKD is defined by estimated Glomerular Filtration Rate (eGFR) below 75 mL/min/1.73m2.
- All acute toxic effects (excluding alopecia) of any prior therapy must have been resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v.5.0) Grade ≤ 1.
- Women Of Childbearing Potential (WOCBP) must have negative pregnancy test results at screening. WOCBP must be using, from screening to six months following the last study treatment administration, highly effective contraception methods, as defined by the "Recommendations for contraception and pregnancy testing in clinical trials" issued by the Head of Medicine Agencies' Clinical Trial Facilitation Group and which include, for instance, progesterone-only or combined (estrogen- and progesterone-containing) hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone-releasing systems, bilateral tubal occlusion, vasectomized partner. Double-barrier contraception is required.
- Male patients with WOCBP partners must agree to use simultaneously two acceptable methods of contraception (i.e. spermicidal gel plus condom) from the screening to six months following the last study treatment administration. Double-barrier contraception is required.
- Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
Who cannot join
- 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:
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- 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.
- Inadequate liver function (ALT, AST, ALP ≥ 2.5 x ULN or total bilirubin ≥ 2.0 x ULN). At the discretion of the investigator, an increased exclusion threshold for patients with liver metastasis can be accepted as follows: ALT, AST and ALP ≥ 5 x ULN.
- 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.
- Patient requires or is taking systemic corticosteroids (> 10 mg/day prednisone or equivalent) or other immunosuppressant drugs on a long-term basis. Limited use of corticosteroids to treat or prevent acute hypersensitivity reactions and asthma/COPD is not considered an exclusion criterion.
- Known history of allergy to an excipient in study medication (e.g. IL2, ruxolitinib) or other human proteins/peptides/antibodies.
- Pregnancy or breast-feeding.
- Severe diabetic retinopathy.
- Recovery from major trauma including surgery within 4 weeks prior to enrollment.
- Patient with iatrogenic or pathologic severe immune suppression.
- Requirement of concurrent use of other anti-cancer treatments or agents other than study medication.
- Patient taking herbal medications within 7 days prior to study treatment start.
- Anticoagulation therapy with P2Y12 antagonists (e.g., clopidogrel, ticagrelor) and vitamin K antagonists (e.g., phenprocoumon, warfarin).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Fondazione Policlinico Gemelli Unità di Fase 1: Unità di Farmacologia Clinica
Roma, Roma, 00168
Gennaro Daniele, +39 06 30158802, gennaro.daniele@policlinicogemelli.it
About this study
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
- Renal Carcinoma Metastatic, Pancreatic Adenocarcinoma Metastatic, Pancreatic Adenocarcinoma, Metastatic Colorectal Carcinoma (mCRC)
- Being tested
- L19IL2, Ruxolitinib
- Keywords
- Ruxolitinib, Advanced solid tumors
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L19IL2Drug
Intravenous administration
RuxolitinibDrug
10 mg twice, oral administration
| Study group | Role | What they receive |
|---|---|---|
| Experimental L19IL2 dose escalation intravenous administration | Experimental | Not described Receives: Drug: L19IL2 |
| Experimental L19IL2 + Ruxolitinib dose escalation intravenous administration | Experimental | Not described Receives: Drug: L19IL2; Drug: Ruxolitinib |
| Experimental L19IL2 + Ruxolitinib dose expansion intravenous administration | Experimental | Not described Receives: Drug: L19IL2; Drug: Ruxolitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
STEP A and STEP B: DLT
Occurrence of Dose Limiting Toxicity (DLT) of L19IL2 alone and in combination with ruxolitinib
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Through study completion, an average of 1 year
Secondary outcomes (9)
Overall Response Rate (ORR)
Overall Response Rate (ORR, including CR and PR) as per RECIST 1.1
Measured: Every 8 weeks from treatment start (every 2 cycles; each cycle is 28 days)
Disease Control Rate (DCR)
Disease Control Rate (DCR, including CR, PR, and SD) as per RECIST 1.1
Measured: Every 8 weeks from treatment start (every 2 cycles; each cycle is 28 days)
DoR
Duration of Response (DoR)
Measured: Every 8 weeks from treatment start (every 2 cycles; each cycle is 28 days)
PSF
Progression Free Survival (PFS)
Measured: Every 8 weeks from treatment start (every 2 cycles; each cycle is 28 days)
Human anti-fusion protein antibody (HAFA)
Blood samples will be obtained to assess the potential development of antibody to L19IL2.
Measured: Day 1 and 8 of cycle 1; Day 1 of cycle 2, 3, 4, 5, 6. Each cycle is 28 days.
Maximum Plasma Concentration (Cmax)
Maximum observed plasma concentration (Cmax) of L19IL2 and ruxolitinib following administration
Measured: Day 1, 2, 8, 15, 22, 23 of Cycle 1 and Day 1 of Cycles 2, 3, 4, 5, and 6 (each cycle is 28 days)
Time to Maximum Plasma Concentration (Tmax)
Time to reach maximum observed plasma concentration (Tmax) of L19IL2 and ruxolitinib.
Measured: Day 1, 2, 8, 15, 22, 23 of Cycle 1 and Day 1 of Cycles 2, 3, 4, 5, and 6 (each cycle is 28 days)
Area Under Concentration (AUC)
Area under the plasma concentration-time curve (AUC) of L19IL2 and ruxolitinib
Measured: Day 1, 2, 8, 15, 22, 23 of Cycle 1 and Day 1 of Cycles 2, 3, 4, 5, and 6 (each cycle is 28 days)
Terminal Elimination Half-life (t½)
Terminal elimination half-life (t½) of L19IL2 and ruxolitinib
Measured: Day 1, 2, 8, 15, 22, 23 of Cycle 1 and Day 1 of Cycles 2, 3, 4, 5, and 6 (each cycle is 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study start1 May 2026 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Carcinoma MetastaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Philogen S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07566897
- Sponsor's protocol ID
- PH-L19IL2CORK-01/25
- Other IDs
- 2025-522243-17-00, 2025
- Status last verified
- Apr 2026
- First submitted
- 15 Apr 2026
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Safety and Efficacy of L19IL2 in Combination With Ruxolitinib in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07566897
- Acronym / sponsor ID
- PH-L19IL2CORK-01/25
- Conditions
- Renal Carcinoma Metastatic, Pancreatic Adenocarcinoma Metastatic, Pancreatic Adenocarcinoma, Metastatic Colorectal Carcinoma (mCRC)
- Keywords
- Ruxolitinib, Advanced solid tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Philogen S.p.A.Industry (pharma, biotech, devices)
- Study start
- 1 May 2026 (estimated)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 5 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Histologically or cytologically confirmed diagnosis of one of the following tumor types for which no further approved systemic treatment options are available:
- 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.
Key exclusion criteria (25 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L19IL2Intravenous administration | Drug | Experimental L19IL2 + Ruxolitinib dose escalation intravenous administration, Experimental L19IL2 + Ruxolitinib dose expansion intravenous administration, Experimental L19IL2 dose escalation intravenous administration |
| Ruxolitinib10 mg twice, oral administration | Drug | Experimental L19IL2 + Ruxolitinib dose escalation intravenous administration, Experimental L19IL2 + Ruxolitinib dose expansion intravenous administration |
Primary outcome
STEP A and STEP B: DLT
Time frame: From Day 1 to Day 28 of the treatment
Occurrence of Dose Limiting Toxicity (DLT) of L19IL2 alone and in combination with ruxolitinib
Safety (AE)
Time frame: Through study completion, an average of 1 year
Adverse Events (AEs) of administration of L19IL2 alone and in combination with ruxolitinib, assessed by Common Toxicity Criteria (version 5.0, CTCAE)
Safety (SAEs)
Time frame: Through study completion, an average of 1 year
Serious Adverse Events(SAEs) of administration of L19IL2 alone and in combination with ruxolitinib, assessed by Common Toxicity Criteria (version 5.0, CTCAE)
Safety (DILI)
Time frame: Through study completion, an average of 1 year
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)
9 secondary outcomes
Overall Response Rate (ORR)
Time frame: Every 8 weeks from treatment start (every 2 cycles; each cycle is 28 days)
Disease Control Rate (DCR)
Time frame: Every 8 weeks from treatment start (every 2 cycles; each cycle is 28 days)
DoR
Time frame: Every 8 weeks from treatment start (every 2 cycles; each cycle is 28 days)
PSF
Time frame: Every 8 weeks from treatment start (every 2 cycles; each cycle is 28 days)
Human anti-fusion protein antibody (HAFA)
Time frame: Day 1 and 8 of cycle 1; Day 1 of cycle 2, 3, 4, 5, 6. Each cycle is 28 days.
Maximum Plasma Concentration (Cmax)
Time frame: Day 1, 2, 8, 15, 22, 23 of Cycle 1 and Day 1 of Cycles 2, 3, 4, 5, and 6 (each cycle is 28 days)
Time to Maximum Plasma Concentration (Tmax)
Time frame: Day 1, 2, 8, 15, 22, 23 of Cycle 1 and Day 1 of Cycles 2, 3, 4, 5, and 6 (each cycle is 28 days)
Area Under Concentration (AUC)
Time frame: Day 1, 2, 8, 15, 22, 23 of Cycle 1 and Day 1 of Cycles 2, 3, 4, 5, and 6 (each cycle is 28 days)
Terminal Elimination Half-life (t½)
Time frame: Day 1, 2, 8, 15, 22, 23 of Cycle 1 and Day 1 of Cycles 2, 3, 4, 5, and 6 (each cycle is 28 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing L19IL2 and Ruxolitinib in people with Renal Carcinoma Metastatic and Pancreatic Adenocarcinoma Metastatic, run by Philogen S.p.A. at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claudio Nanni (+39 057717816, regulatory@philogen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
STEP A and STEP B: DLT (time frame: From Day 1 to Day 28 of the treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.