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Tests treatment safety and results for FAP
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
ClinicalTrials.gov ID: NCT06640413
What this study is testing
What is [177Lu]Lu-OncoFAP-23?
[177Lu]Lu-OncoFAP-23 is an investigational medicine, being studied as a potential treatment for fap.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- 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...
- 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...
- 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...
See the full eligibility criteria
Who can 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.
- 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...
- 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...
- 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...
- Male patients: male people 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...
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Bergamo, Bergamo, Italy
- Milan, Milano, Italy
- Naples, Napoli, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bergamo, Bergamo, Italy; Milan, Milano, Italy; Naples, Napoli, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.