What is [177Lu]Lu-OncoFAP-23 studying for metastatic FAP-positive solid tumors?

This trial is studying the safety and early signs of effectiveness of the drug [177Lu]Lu-OncoFAP-23 alone or combined with L19-IL2 in patients with advanced tumors that test positive for Fibroblast Activation Protein. The research aims to find the best dose and assess how these treatments might work. The study is sponsored by Philogen S.p.A.

Who may be eligible for this metastatic FAP-positive solid tumor clinical trial?

Adults aged 18 or older with advanced or metastatic FAP-positive solid tumors who have progressed on standard treatments may be eligible. Both males and females who are not pregnant or breastfeeding can join. Important factors include having measurable tumors, adequate organ function, and no recent cancer therapy. Please review eligibility criteria for more details.

Is there any cost to participate in this metastatic FAP-positive solid tumor clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses and related costs may vary and are not guaranteed to be covered. Participants should plan accordingly.

Actively Recruiting

Phase 1

Age: 18Years +

All Genders

ID06640413

Phase I Study of 177LuLu-OncoFAP-23 Alone or With L19-IL2 for Advanced FAP-positive Solid Tumors

Led by Philogen S.p.A. · Updated on 2026-01-14

Participants Needed

Research Sites

30 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and early signs of effectiveness of a drug called 177LuLu-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 177LuLu-OncoFAP-23 to identify the maximum tolerated dose and recommended dose. In the second part, more patients receive either the recommended dose of 177LuLu-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

Age: 18Years +

All Genders

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

Research Team

Jacqueline Mock, PhD

Federica Bastioli, Pharmaceutical Chemist

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