FAPPhase 1TheraTriNCT06640413
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
A Phase 1 study testing [177Lu]Lu-OncoFAP-23 and L19IL2 in people with FAP, run by Philogen S.p.A. at 4 sites in Italy.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- FAP
- What is being tested?
- [177Lu]Lu-OncoFAP-23 and L19IL2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 4 sitesItaly
- Study dates
- 31 Oct 2025to 31 Dec 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with advanced/metastatic solid tumors, who have progressed on available standard treatments.
- Patients with FAP-positive tumors as evaluated by [68Ga]Ga-OncoFAP-DOTAGA-PET/CT imaging.
- Patients without other therapeutic alternatives with curative or survival prolonging potential as per investigator judgement.
- Male or non-pregnant and non-breast feeding female, age 18 or more.
- Patients must have at least one unidimensionally measurable lesion by computed tomography as defined by RECIST criteria 1.1. This lesion should not have been irradiated during previous treatments.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
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- Survival expectation of more than 12 weeks.
- Ability to undergo standard imaging.
- Documented negative test for Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV). For HBV serology: the determination of HBsAg and anti-HBcAg-Ab is required. In patients with serology documenting previous exposure to HBV (i.e., anti-HBsAg-Ab with no history of vaccination and/or anti-HBcAg-Ab), negative serum HBV-DNA is required. For HCV: HCV-RNA or HCV antibody test. Subjects with a positive test for HCV antibody but no detection of HCV-RNA indicating no current infection are eligible.
- All acute toxic effects (excluding alopecia and fatigue) of any prior therapy (including surgery, radiation therapy, chemotherapy) must have resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (v. 5.0) Grade ≤ 1.
- Female patients: negative blood pregnancy test at Screening for women of childbearing potential (WOCBP)*. WOCBP must agree to use, from the screening to six months following the last study drug administration, highly effective contraception methods, as defined by the Recommendations for contraception and pregnancy testing in clinical ; issued by the Head of Medicine Agencies; Clinical Trial Facilitation Group (www.hma.eu/ctfg.html) and which include, for instance, progesterone-only or combined (estrogen- and progesterone-containing) hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone-releasing systems, bilateral tubal occlusion or vasectomized partner.
- Male patients: male subjects able to father children must agree to use two acceptable methods of contraception throughout the study (e.g., condom with spermicidal gel). Double-barrier contraception is required.
- A personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study and has given consent to participate in the study.
- Willingness and ability to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures.
- Women of childbearing potential are defined as females who have experienced menarche, are not postmenopausal (12 months with no menses without an alternative medical cause) and are not permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral oophorectomy or bilateral salpingectomy).
Who cannot join
- Any cancer therapy within 4 weeks of study entry.
- Active or history of autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent.
- Previous treatment with Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, Iodine-131, Lutetium-177 conjugates or hemi-body irradiation within 6 months prior to enrollment.
- White blood cell count (WBC) minor than 2.5 x 109/L, absolute neutrophil count (ANC) minor than 1.5 x 109/L, platelets minor than 100 x 109/L or hemoglobin (Hb) minor than 9.0 g/dl,
- Chronically impaired renal function as expressed by creatinine clearance minor than 60 mL/min or serum creatinine major than 1.5 ULN.
- Inadequate liver function (Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) ≥ 3 x Upper Limit of Normal (ULN), or Alkaline Phosphatase (ALP) or Gamma Glutamyl Transferase (GGT) ≥ 2.5 x ULN, or total bilirubin ≥ 1.5 x ULN). For patients with metastatic lesions in the liver ALT, AST, GGT or ALP ≥ 5 x ULN.
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- Presence of cirrhosis or active hepatitis.
- Patients with Central Nervous System (CNS) metastases.
- History within the last year of cerebrovascular disease and/or acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris.
- Heart insufficiency (major Grade II, New York Heart Association (NYHA) criteria).
- Clinically significant cardiac arrhythmias or requiring permanent medication.
- Abnormal Left Ventricular Ejection Fraction (LVEF) or any other abnormalities observed during baseline Electrocardiogram (ECG) and echocardiogram investigations that are considered as clinically significant by the investigator. Subjects with current, or a history of QT/QTc prolongation would be excluded. In particular: - patients with a marked prolongation of QT/QTc interval (e.g., repeated demonstration of QTc major than 480 milliseconds using Fredricia's QT correction formula) are excluded; - patients with a history of risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, family history of prolonged QT syndrome) are excluded; - patients who require the use of concomitant medications that prolong the QT/QTc interval are excluded.
- Cardioversion in the previous 12 months
- Uncontrolled hypertension as defined by systolic blood pressure ≥ 140 mmHg and diastolic blood pressure ≥ 90 mmHg at 3 consecutive measurements performed within one week. Note: if the first blood pressure measurement is below threshold for systolic or diastolic blood pressure, it is not required to repeat the measurement.
- Ischemic peripheral vascular disease (Grade IIb-IV according to Leriche-Fontaine classification).
- Severe diabetic retinopathy such as severe non-proliferative retinopathy and proliferative retinopathy.
- Pregnancy or lactation or unwillingness to use adequate method of birth control.
- Any severe concomitant condition which in the opinion of investigators makes it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol.
- Major trauma including major surgery (such as abdominal/cardiac/thoracic surgery) within 4 weeks of administration of the study drug.
- Serious, non-healing wound, ulcer or bone fracture.
- Known history of allergy to an excipient in study medication or any other intravenously administered human proteins/peptides/antibodies
- Systemic chronic steroid therapy (major than 10 mg/day prednisone or equivalent) or any other immunosuppressive therapy within 14 days prior to study treatment start. Topical, inhaled, nasal and ophthalmic steroids are allowed.
- Presence of active and uncontrolled 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.
- Concurrent or previous malignancies (other than the indication for this trial), unless a complete remission without further recurrence was achieved at least 2 years prior to study treatment start.
- Growth factors or immunomodulatory agents within 7 days prior to study treatment start.
- Deep vein thrombosis, pulmonary embolism, or other acute vascular events within 6 months.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Federica Bastioli, Pharmaceutical Chemist contact
Italy4 sites, 4 recruiting
- Recruiting
ASST Papa Giovanni XXIII Piazza OMS
Bergamo, Bergamo, 24127
Paola Anna Erba, Prof MD PhD, +390352674642, paolaanna.erba@unimib.it
Paola Anna Erba, Prof MD PhD
- Recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Milano, 20133
Margarita Kirienko, MD PhD, +390223903084, margarita.kirienko@istitutotumori.mi.it
Margarita Kirienko, MD PhD
- Not yet recruiting
Istituto Europeo di Oncologia
Milan, Milano, 20141
Giuseppe Curigliano, MD PhD, +390257489960, Giuseppe.curigliano@ieo.it
Giuseppe Curigliano, MD PhD
- Not yet recruiting
Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale" Via Mariano Semmola
Naples, Napoli, 80131
Francesca Di Giacomo, MD, +3908117770329, f.digennaro@istitutotumori.na.it
Francesca Di Gennaro, MD
About this study
Official title: 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
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).
Read the detailed description
This study is a prospective phase I, open-label, multiple ascending, multi-center dose escalation study to evaluate the safety and preliminary signs of efficacy of [177Lu]Lu-OncoFAP-23 alone and in combination with the antibody-cytokine conjugate L19-IL2 for the treatment of advanced/metastatic FAP-positive solid tumors.
Eligible patients for this trial are male or non-pregnant and non-breastfeeding females aged 18 years or more, able to give informed consent.
Up to 56 evaluable patients will be enrolled in the trial and the trial is divided into two parts:
- Part I - Dose escalation part (2-36 pts) This dose escalation part of the study is designed as a standard 3+3 escalation scheme. Not more than 2 patients per cohort are treated simultaneously during the Dose Limiting Toxicity (DLT) observation period from Day 1 to Day 28 of the first cycle. Patients per cohort will be assigned to different dose levels of the study drug.
- Part II - Dose expansion part (20 pts) After completion of the dose escalation part, additional 20 patients will be enrolled at the RD to better understand the safety profile and to explore early signs of efficacy in different disease indications. Patients will be randomly assigned to arm 1 (monotherapy) or arm 2 (combination therapy) (10 patients each).
Both in part I and II, patients can receive up to 4 consecutive cycles of radioligand therapy every 8 (± 1) weeks.
The primary objective 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 FAP-positive malignancies and to establish a Recommended Dose (RD).
Secondary objectives include evaluation of pharmacokinetics and the collection of initial signs of efficacy of the treatment.
- Conditions
- FAP
- Being tested
- [177Lu]Lu-OncoFAP-23, L19IL2
- Keywords
- Patients with advanced/metastatic FAP-positive tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[177Lu]Lu-OncoFAP-23Drug
3.7, 7.4, or 11.1 GBq to define the RD
L19IL2Drug
22.5 Mio IU
| Study group | Role | What they receive |
|---|---|---|
| Part I - Dose Escalation - Cohort 1, Arm 1 | Experimental | In Arm 1, patients assigned to this cohort 1, receive monotherapy of [177Lu]Lu-OncoFAP-23 (3.7 GBq) Receives: Drug: [177Lu]Lu-OncoFAP-23 |
| Part I - Dose Escalation - Cohort 2, Arm 1 | Experimental | In Arm 1, patients assigned to this cohort 2, receive monotherapy of [177Lu]Lu-OncoFAP-23 (7.4 GBq) Receives: Drug: [177Lu]Lu-OncoFAP-23 |
| Part I - Dose Escalation - Cohort 3, Arm 1 | Experimental | In Arm 1, patients assigned to this cohort 3, receive monotherapy of [177Lu]Lu-OncoFAP-23 (11.1 GBq) Receives: Drug: [177Lu]Lu-OncoFAP-23 |
| Part I - Dose Escalation - Cohort 4, Arm 2 | Experimental | In Arm 2, patients assigned to this cohort 4, receive combination of [177Lu]Lu-OncoFAP-23 at at the dose level below the Maximum Tolerated Dose (MTD) with L19IL2 (22.5 Mio IU). Receives: Drug: [177Lu]Lu-OncoFAP-23; Drug: L19IL2 |
| Part I - Dose Escalation - Cohort 5, Arm 2 | Experimental | In Arm 2, patients assigned to this cohort 4, receive combination of [177Lu]Lu-OncoFAP-23 at MTD with L19IL2 (22.5 Mio IU). Receives: Drug: [177Lu]Lu-OncoFAP-23; Drug: L19IL2 |
| Part II - Dose Expansion - Arm 1 | Experimental | 10 patients receive the monotherapy of [177Lu]Lu-OncoFAP-23 at the recommended dose Receives: Drug: [177Lu]Lu-OncoFAP-23 |
| Part II - Dose Expansion - Arm 2 | Experimental | 10 patients receive the combination of [177Lu]Lu-OncoFAP-23 and L19IL2 at the recommended doses Receives: Drug: [177Lu]Lu-OncoFAP-23; Drug: L19IL2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicity
Dose Limiting Toxicity (DLT)
Measured: From Day 1 to 28 of the dose escalation part
Maximum Tolerated Dose (MTD) and Recommended Dose (RD)
Maximum Tolerated Dose (MTD) and Recommended Dose (RD)
Measured: From Day 1 to 28 of the dose escalation part
Maximum Administered Dose (MAD)
Maximum Administered Dose (MAD)
Measured: From Day 1 to 28 of the dose escalation part
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Adverse events (AEs) and Serious Adverse Events (SAEs) assessment based on Common Terminology Criteria for Adverse Events v. 5.0 (CTCAE)
Measured: through study completion, maximum 1 year
Drug Induced Liver Injury (DILI)
Drug Induced Liver Injury (DILI) assessment based on Common Terminology Criteria for Adverse Events v. 5.0 (CTCAE)
Measured: through study completion, maximum 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start31 Oct 2025
- Primary completion31 May 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FAPStudies of the same condition, open and under way.
- More trials run by Philogen S.p.A.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- In Part I patients are assigned to 5 sequential dose escalation cohorts. In this part, two arms are foreseen: Arm 1 foresees cohort 1-3 with monotherapy of \[177Lu\]Lu-OncoFAP-23 (3.7, 7.4, 11.1 GBq respectively); Arm 2, only opened when the MTD and RD is established, has cohorts 4-5 that are run with \[177Lu\]Lu-OncoFAP-23 in combination with L19IL2 at 22.5 Mio International Units (IU). In Part II, 10 patients are randomly assigned to Arm 1 (monotherapy of \[177Lu\]Lu-OncoFAP-23 at the recommended dose) and 10 patients are randomly assigned to Arm 2 (combination of \[177Lu\]Lu-OncoFAP-23 and L19IL2 at the recommended doses).
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Philogen S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06640413
- Sponsor's protocol ID
- PH-FAPLU-02/23
- Other IDs
- 2023-509453-31-00, 2023
- Acronym
- TheraTri
- Status last verified
- Oct 2026
- First submitted
- 10 Oct 2024
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06640413
- Acronym / sponsor ID
- TheraTri / PH-FAPLU-02/23
- Conditions
- FAP
- Keywords
- Patients with advanced/metastatic FAP-positive tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Philogen S.p.A.Industry (pharma, biotech, devices)
- Study start
- 31 Oct 2025 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This study is a prospective phase I, open-label, multiple ascending, multi-center dose escalation study to evaluate the safety and preliminary signs of efficacy of [177Lu]Lu-OncoFAP-23 alone and in combination with the antibody-cytokine conjugate L19-IL2 for the treatment of advanced/metastatic FAP-positive solid tumors.
Eligible patients for this trial are male or non-pregnant and non-breastfeeding females aged 18 years or more, able to give informed consent.
Up to 56 evaluable patients will be enrolled in the trial and the trial is divided into two parts:
- Part I - Dose escalation part (2-36 pts) This dose escalation part of the study is designed as a standard 3+3 escalation scheme. Not more than 2 patients per cohort are treated simultaneously during the Dose Limiting Toxicity (DLT) observation period from Day 1 to Day 28 of the first cycle. Patients per cohort will be assigned to different dose levels of the study drug.
- Part II - Dose expansion part (20 pts) After completion of the dose escalation part, additional 20 patients will be enrolled at the RD to better understand the safety profile and to explore early signs of efficacy in different disease indications. Patients will be randomly assigned to arm 1 (monotherapy) or arm 2 (combination therapy) (10 patients each).
Both in part I and II, patients can receive up to 4 consecutive cycles of radioligand therapy every 8 (± 1) weeks.
The primary objective 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 FAP-positive malignancies and to establish a Recommended Dose (RD).
Secondary objectives include evaluation of pharmacokinetics and the collection of initial signs of efficacy of the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 7
- Model description
- In Part I patients are assigned to 5 sequential dose escalation cohorts. In this part, two arms are foreseen: Arm 1 foresees cohort 1-3 with monotherapy of [177Lu]Lu-OncoFAP-23 (3.7, 7.4, 11.1 GBq respectively); Arm 2, only opened when the MTD and RD is established, has cohorts 4-5 that are run with [177Lu]Lu-OncoFAP-23 in combination with L19IL2 at 22.5 Mio International Units (IU). In Part II, 10 patients are randomly assigned to Arm 1 (monotherapy of [177Lu]Lu-OncoFAP-23 at the recommended dose) and 10 patients are randomly assigned to Arm 2 (combination of [177Lu]Lu-OncoFAP-23 and L19IL2 at the recommended doses).
| Arm | Type | Receives |
|---|---|---|
| Part I - Dose Escalation - Cohort 1, Arm 1 | Experimental | Drug: [177Lu]Lu-OncoFAP-23In Arm 1, patients assigned to this cohort 1, receive monotherapy of [177Lu]Lu-OncoFAP-23 (3.7 GBq) |
| Part I - Dose Escalation - Cohort 2, Arm 1 | Experimental | Drug: [177Lu]Lu-OncoFAP-23In Arm 1, patients assigned to this cohort 2, receive monotherapy of [177Lu]Lu-OncoFAP-23 (7.4 GBq) |
| Part I - Dose Escalation - Cohort 3, Arm 1 | Experimental | Drug: [177Lu]Lu-OncoFAP-23In Arm 1, patients assigned to this cohort 3, receive monotherapy of [177Lu]Lu-OncoFAP-23 (11.1 GBq) |
| Part I - Dose Escalation - Cohort 4, Arm 2 | Experimental | Drug: [177Lu]Lu-OncoFAP-23, Drug: L19IL2In Arm 2, patients assigned to this cohort 4, receive combination of [177Lu]Lu-OncoFAP-23 at at the dose level below the Maximum Tolerated Dose (MTD) with L19IL2 (22.5 Mio IU). |
| Part I - Dose Escalation - Cohort 5, Arm 2 | Experimental | Drug: [177Lu]Lu-OncoFAP-23, Drug: L19IL2In Arm 2, patients assigned to this cohort 4, receive combination of [177Lu]Lu-OncoFAP-23 at MTD with L19IL2 (22.5 Mio IU). |
| Part II - Dose Expansion - Arm 1 | Experimental | Drug: [177Lu]Lu-OncoFAP-2310 patients receive the monotherapy of [177Lu]Lu-OncoFAP-23 at the recommended dose |
| Part II - Dose Expansion - Arm 2 | Experimental | Drug: [177Lu]Lu-OncoFAP-23, Drug: L19IL210 patients receive the combination of [177Lu]Lu-OncoFAP-23 and L19IL2 at the recommended doses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients with advanced/metastatic solid tumors, who have progressed on available standard treatments.
- Patients with FAP-positive tumors as evaluated by [68Ga]Ga-OncoFAP-DOTAGA-PET/CT imaging.
- Patients without other therapeutic alternatives with curative or survival prolonging potential as per investigator judgement.
- Male or non-pregnant and non-breast feeding female, age 18 or more.
- Patients must have at least one unidimensionally measurable lesion by computed tomography as defined by RECIST criteria 1.1. This lesion should not have been irradiated during previous treatments.
Key exclusion criteria (26 listed)
- Any cancer therapy within 4 weeks of study entry.
- Active or history of autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent.
- Previous treatment with Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, Iodine-131, Lutetium-177 conjugates or hemi-body irradiation within 6 months prior to enrollment.
- White blood cell count (WBC) minor than 2.5 x 109/L, absolute neutrophil count (ANC) minor than 1.5 x 109/L, platelets minor than 100 x 109/L or hemoglobin (Hb) minor than 9.0 g/dl,
- Chronically impaired renal function as expressed by creatinine clearance minor than 60 mL/min or serum creatinine major than 1.5 ULN.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [177Lu]Lu-OncoFAP-233.7, 7.4, or 11.1 GBq to define the RD | Drug | Part I - Dose Escalation - Cohort 1, Arm 1, Part I - Dose Escalation - Cohort 2, Arm 1, Part I - Dose Escalation - Cohort 3, Arm 1, Part I - Dose Escalation - Cohort 4, Arm 2, Part I - Dose Escalation - Cohort 5, Arm 2, Part II - Dose Expansion - Arm 1, Part II - Dose Expansion - Arm 2 |
| L19IL222.5 Mio IU | Drug | Part I - Dose Escalation - Cohort 4, Arm 2, Part I - Dose Escalation - Cohort 5, Arm 2, Part II - Dose Expansion - Arm 2 |
Primary outcome
Dose Limiting Toxicity
Time frame: From Day 1 to 28 of the dose escalation part
Dose Limiting Toxicity (DLT)
Maximum Tolerated Dose (MTD) and Recommended Dose (RD)
Time frame: From Day 1 to 28 of the dose escalation part
Maximum Tolerated Dose (MTD) and Recommended Dose (RD)
Maximum Administered Dose (MAD)
Time frame: From Day 1 to 28 of the dose escalation part
Maximum Administered Dose (MAD)
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: through study completion, maximum 1 year
Adverse events (AEs) and Serious Adverse Events (SAEs) assessment based on Common Terminology Criteria for Adverse Events v. 5.0 (CTCAE)
Drug Induced Liver Injury (DILI)
Time frame: through study completion, maximum 1 year
Drug Induced Liver Injury (DILI) assessment based on Common Terminology Criteria for Adverse Events v. 5.0 (CTCAE)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Federica Bastioli, Pharmaceutical Chemist contact
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [177Lu]Lu-OncoFAP-23 and L19IL2 in people with FAP, run by Philogen S.p.A. at 4 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jacqueline Mock, PhD (+41435448802, regulatory@philogen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limiting Toxicity (time frame: From Day 1 to 28 of the dose escalation part). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.