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Radioligand Therapy
Radioligand Therapy for Advanced Cancer
Phase 1
Recruiting
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with locally advanced unresectable or metastatic PDAC, locally advanced unresectable or metastatic GEA, or recurrent GBM
To be treated with [177Lu]Lu-FF58, patients must have at least one measurable lesion that shows [68Ga]Ga-FF58 uptake on PET/CT or PET/MRI
Must not have
Prior external beam radiation therapy (EBRT) to > 25% of the bone marrow
Unmanageable bladder outflow obstruction or urinary incontinence
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from start of study treatment until date of progression, assessed up to approximately 34 months
Awards & highlights
Summary
This trial aims to test the safety and proper dosage of a new radioligand therapy called [177Lu]Lu-FF58 for patients with advanced tumors that express specific proteins. The study will
Who is the study for?
This trial is for adults over 18 with advanced or metastatic tumors, specifically adenocarcinoma, glioblastoma, pancreatic cancer, and gastroesophageal adenocarcinoma. Participants must have at least one measurable tumor lesion that absorbs a diagnostic agent seen on PET scans.
What is being tested?
[177Lu]Lu-FF58, a new radioligand therapy targeting certain proteins in tumors (integrins αvβ3 and αvβ5), is being tested for safety and proper dosage. The imaging agent [68Ga]Ga-FF58's ability to detect tumors will also be evaluated.
What are the potential side effects?
Potential side effects may include reactions related to radiation exposure such as nausea, fatigue, or local irritation at the injection site. As this is an early-phase study assessing safety, additional unexpected side effects could occur.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is advanced and cannot be removed by surgery.
Select...
I have a tumor visible on scans that absorbs a specific diagnostic dye.
Select...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had radiation therapy to more than a quarter of my bone marrow.
Select...
I have severe issues controlling my bladder or emptying it completely.
Select...
I have brain metastases needing treatment or increased steroids recently.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from start of study treatment until date of progression, assessed up to approximately 34 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from start of study treatment until date of progression, assessed up to approximately 34 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose intensity for 177Lu-FF58
Dose modifications for 177Lu-FF58
Incidence and severity of adverse events and serious adverse events of 177Lu-FF58
+1 moreSecondary outcome measures
Absorbed dose of 177Lu-FF58
Area Under the Curve (AUC) from 177Lu-FF58 blood radioactivity data
Disease control rate (DCR)
+11 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Arm 1Experimental Treatment2 Interventions
Patients will receive 68Ga-FF58 and only patients with tumor uptake of 68Ga-FF58 will receive 177Lu-FF58.
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Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,889 Previous Clinical Trials
4,203,285 Total Patients Enrolled
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