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A Phase I Study of [177Lu]Lu-FF58 in Patients With Advanced Solid Tumors.

NCT05977322 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-12-24

No results posted yet for this study

Summary

The purpose of the study is to test the safety and dosing of \[177Lu\]Lu-FF58, a radioligand therapy for patients with advanced or metastatic tumors that express proteins known as integrins: alpha-v beta-3 integrin (αvβ3) and alpha-v beta-5 integrin (αvβ5). The study will also further characterize the radioligand imaging agent \[68Ga\]Ga-FF58 including its ability to identify tumor lesions and its safety profile.

Conditions

Interventions

DRUG

68Ga-FF58

Kit for radiopharmaceutical preparation of 68Ga- FF58 solution for injection

DRUG

177Lu-FF58

Solution for injection/infusion

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-06
Primary Completion
2024-12-13
Completion
2024-12-13
FDA Drug
Yes

Countries

  • Israel
  • Netherlands
  • Spain
  • Switzerland

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05977322 on ClinicalTrials.gov