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

Sponsor
Philogen S.p.A.
Study ID
NCT07566897
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • L19IL2 — DRUG
    Intravenous administration
  • Ruxolitinib — DRUG
    10 mg twice, oral administration

Study Details

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.

Key Dates

Start date
May 1, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2029
Completion
May 31, 2030

Study Design

Enrollment
96 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental L19IL2 dose escalation intravenous administration
  • Experimental: Experimental L19IL2 + Ruxolitinib dose escalation intravenous administration
  • Experimental: Experimental L19IL2 + Ruxolitinib dose expansion intravenous administration

Primary Outcome Measure

STEP A and STEP B: DLT [ Time Frame: From Day 1 to Day 28 of the treatment ]

Central Contacts

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