Actively Recruiting
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
Led by Philogen S.p.A. · Updated on 2026-01-14
56
Participants Needed
4
Research Sites
165 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The aim of this study is to assess the safety of \[177Lu\]Lu-OncoFAP-23 alone or in combination with L19-IL2 for the treatment of advanced/metastatic Fibroblast Activation Protein (FAP)-positive solid tumors and to establish a Recommended Dose (RD).
CONDITIONS
Official 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 who have progressed on standard treatments.
- Tumors must be positive for FAP on specialized PET/CT imaging.
- Patients without other curative or survival-prolonging treatment options.
- Male or non-pregnant, non-breastfeeding female patients aged 18 or older.
- At least one measurable tumor lesion by CT scan not previously irradiated.
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less.
- Expected survival of more than 12 weeks.
- Ability to undergo standard imaging procedures.
- Negative tests for HIV, Hepatitis B, and Hepatitis C as specified.
- Prior therapy side effects resolved to mild or less (Grade 1 or less).
- Women of childbearing potential must have negative pregnancy test and agree to effective contraception.
- Male patients able to father children must agree to use two contraception methods during the study.
- 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 immune stimulation.
- Prior treatment with certain radionuclide therapies or hemi-body irradiation within 6 months.
- Low blood counts below specified limits.
- Impaired kidney function or abnormal liver function above specified thresholds.
- Presence of cirrhosis, active hepatitis, or central nervous system metastases.
- Recent serious cardiovascular events or heart conditions.
- Clinically significant heart rhythm abnormalities or abnormal ECG findings.
- Uncontrolled high blood pressure.
- Peripheral vascular disease of moderate to severe grade.
- Severe diabetic retinopathy.
- Pregnancy, lactation, or unwillingness to use birth control.
- Severe other medical conditions or recent major surgery or trauma.
- Known allergies to study medication ingredients.
- Use of systemic steroids above specified doses or immunosuppressants recently.
- Active uncontrolled infections or serious concurrent diseases.
- Other cancers within past two years unless in complete remission.
- Recent use of growth factors or immunomodulatory agents.
- Recent blood clots or acute vascular events within 6 months.
AI-Screening
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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
CONTACT
F
Federica Bastioli, Pharmaceutical Chemist
CONTACT
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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