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 range18 Years – 75 Years
SexALL
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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.
✓. 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.
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
. 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: