Actively Recruiting
A Phase I Study to Evaluate the Safety and Preliminary Signs of Efficacy of [177Lu]Lu-OncoFAP-23 Alone or in Combination With L19-IL2 as a Treatment of Metastatic FAP-positive Solid Tumors
Led by Philogen S.p.A. · Updated on 2026-01-14
56
Participants Needed
4
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and early signs of effectiveness of a drug called [177Lu]Lu-OncoFAP-23 alone or combined with another drug, L19-IL2, for treating advanced or metastatic solid tumors that test positive for Fibroblast Activation Protein (FAP). This phase I study aims to find the appropriate dose and understand how these treatments may work in patients who have limited treatment options. The study includes two parts: first, a dose escalation phase where small groups of patients receive increasing doses of [177Lu]Lu-OncoFAP-23 to identify the maximum tolerated dose and recommended dose. In the second part, more patients receive either the recommended dose of [177Lu]Lu-OncoFAP-23 alone or combined with L19-IL2. Treatments are given in up to four cycles spaced about eight weeks apart. Participants will undergo regular assessments including imaging scans, blood tests, and monitoring for side effects during and after treatment for up to one year. Researchers will track dose limiting toxicities, liver injury, and other adverse events while also looking for early signs that the treatment might be effective. Patients will have scheduled visits to follow the treatment plan and undergo laboratory tests to evaluate safety and response.
CONDITIONS
Brief Title
A Study to Evaluate the Safety and Preliminary Signs of Efficacy of [177Lu]Lu-OncoFAP-23 Alone or in Combination With L19-IL2 as a Treatment of Metastatic FAP-positive Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with advanced or metastatic solid tumors that have progressed after standard treatments
- Tumors must test positive for Fibroblast Activation Protein (FAP) by specific PET/CT imaging
- No other therapeutic options with curative or survival benefit available as judged by the investigator
- Male or non-pregnant, non-breastfeeding female, age 18 years or older
- At least one measurable tumor lesion by CT scan that has not been previously irradiated
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Expected survival of more than 12 weeks
- Able to undergo standard imaging procedures
- Negative test results for HIV, Hepatitis B, and Hepatitis C infections
- All acute side effects from prior treatments (except hair loss and fatigue) resolved to mild or less
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception
- Male participants able to father children must use two acceptable contraception methods
- Signed informed consent and willingness to comply with study procedures
You will not qualify if you...
- Received any cancer therapy within 4 weeks before study entry
- Active or history of autoimmune disease that could worsen with immunotherapy
- Previous treatment with certain radionuclides or hemi-body irradiation within 6 months
- Low blood counts including white blood cells, neutrophils, platelets, or hemoglobin below specific thresholds
- Impaired kidney function or serum creatinine above normal limits
- Abnormal liver function tests beyond defined levels
- Presence of liver cirrhosis or active hepatitis
- Central nervous system metastases
- Recent history (within one year) of serious heart or blood vessel disease
- Heart failure of major grade or significant arrhythmias
- Abnormal heart function or prolonged QT interval on ECG
- Cardioversion within the last 12 months
- Uncontrolled high blood pressure
- Severe peripheral vascular disease or diabetic retinopathy
- Pregnancy, lactation, or unwillingness to use birth control
- Severe concurrent medical conditions or recent major surgery
- Serious non-healing wounds, ulcers, or fractures
- Known allergy to study medication components
- Use of systemic steroids above 10 mg prednisone or equivalent within 14 days prior
- Active or uncontrolled infections or severe other diseases
- Other malignancies unless in remission for at least 2 years
- Recent use of growth factors or immunomodulatory agents
- Recent vascular events like deep vein thrombosis or pulmonary embolism within 6 months
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 32 weeks
Participants receive up to 4 consecutive cycles of radioligand therapy every 8 (± 1) weeks with either [177Lu]Lu-OncoFAP-23 alone or in combination with L19-IL2, depending on their assigned dose and cohort.
Up to 4 treatment visits every 8 (± 1) weeks
Duration - Up to 1 year after treatment completion
Participants are monitored for safety and preliminary signs of efficacy after completing treatment, including adverse events and drug-induced liver injury assessments.
Regular visits for safety assessments up to 1 year
Trial Site Locations
Total: 4 locations
1
ASST Papa Giovanni XXIII Piazza OMS
Bergamo, Bergamo, Italy, 24127
Actively Recruiting
2
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Milano, Italy, 20133
Actively Recruiting
3
Istituto Europeo di Oncologia
Milan, Milano, Italy, 20141
Not Yet Recruiting
4
Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale" Via Mariano Semmola
Naples, Napoli, Italy, 80131
Not Yet Recruiting
Research Team
J
Jacqueline Mock, PhD
F
Federica Bastioli, Pharmaceutical Chemist
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
7
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