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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 below
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My cancer is advanced and cannot be removed by surgery.
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I have a tumor visible on scans that absorbs a specific diagnostic dye.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had radiation therapy to more than a quarter of my bone marrow.
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I have severe issues controlling my bladder or emptying it completely.
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I have brain metastases needing treatment or increased steroids recently.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from start of study treatment until date of progression, assessed up to approximately 34 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of study treatment until date of progression, assessed up to approximately 34 months for reporting.

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 more
Secondary outcome measures
Absorbed dose of 177Lu-FF58
Area Under the Curve (AUC) from 177Lu-FF58 blood radioactivity data
Disease control rate (DCR)
+11 more

Trial 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
~77 spots leftby Jan 2027
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