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

No Placebo-Only Group

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 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

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.