A Phase I Study to Evaluate the Safety and Efficacy of L19IL2 in Combination With Ruxolitinib in … (NCT07566897) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Phase I Study to Evaluate the Safety and Efficacy of L19IL2 in Combination With Ruxolitinib in Patients With Advanced Solid Tumors
Italy96 participantsStarted 2026-05-01
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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:
. Metastatic proficient mismatch repair / microsatellite stable (pMMR/MSS), BRAF V600E-negative colorectal adenocarcinoma, that has progressed following:
. Metastatic clear cell renal cell carcinoma, that has progressed following:
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
STEP A and STEP B: DLT
Timeframe: From Day 1 to Day 28 of the treatment
2
Safety (AE)
Timeframe: Through study completion, an average of 1 year
3
Safety (SAEs)
Timeframe: Through study completion, an average of 1 year
4
Safety (DILI)
Timeframe: Through study completion, an average of 1 year
. At least one unidimensionally measurable lesion as defined by RECIST v.1.1.
. Eastern cooperative oncology group (ECOG) performance status ≤ 2.
Exclusion criteria
. 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: