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Trial Title:
A Phase I Study of [177Lu]Lu-FF58 in Patients With Advanced Solid Tumors.
NCT ID:
NCT05977322
Condition:
Pancreatic Ductal Adenocarcinoma
Gastroesophageal Adenocarcinoma
Glioblastoma Multiforme
Conditions: Official terms:
Adenocarcinoma
Glioblastoma
Conditions: Keywords:
pancreatic ductal adenocarcinoma
PDAC
pancreatic cancer
gastroesophageal adenocarcinoma
GEA
gastric cancer
gastric adenocarcinoma
esophageal cancer
esophageal adenocarcinoma
glioblastoma multiforme
GBM
advanced solid tumors
radioligand therapy
RLT
[177Lu]Lu-FF58
[68Ga]Ga-FF58
integrins
alpha-v beta-3 integrin
αvβ3
alpha-v beta-5 integrin
αvβ5
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
68Ga-FF58
Description:
Kit for radiopharmaceutical preparation of 68Ga- FF58 solution for injection
Arm group label:
Arm 1
Intervention type:
Drug
Intervention name:
177Lu-FF58
Description:
Solution for injection/infusion
Arm group label:
Arm 1
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.
Detailed description:
The study will be done in two parts. The first part is called "escalation" and the second
part is called "expansion". In both parts of the study, patients will be screened with a
[68Ga]Ga-FF58 positron emission tomography (PET)/computed tomography (CT) or PET/magnetic
resonance imaging (MRI) scan to assess eligibility for treatment with [177Lu]Lu-FF58. In
the escalation part, different doses of [177Lu]Lu-FF58 will be tested to identify the
recommended dose. The expansion part of the study will examine the safety and preliminary
efficacy of [177Lu]Lu-FF58 at the recommended dose determined during the escalation part.
The end of study will occur when at least 80% of the patients in the expansion part have
completed the follow-up for disease progression or discontinued from the study for any
reason, and all patients have completed treatment and the 36 month long term follow- up
period, or the study is terminated early in which case all patients would also be
followed up for safety.
Criteria for eligibility:
Criteria:
Key Inclusion criteria
- Age >= 18 years old
- 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
Key Exclusion criteria
- Absolute neutrophil count (ANC) < 1.5 x 109/L, hemoglobin < 10 g/dL, or platelet
count < 100 x 109/L
- Prior external beam radiation therapy (EBRT) to > 25% of the bone marrow
- Creatinine clearance < 60 mL/min
- Unmanageable bladder outflow obstruction or urinary incontinence
- Non-GBM patients: Presence of symptomatic central nervous system (CNS) metastases,
or CNS metastases that require local CNS-directed therapy (such as radiotherapy or
surgery), or increasing doses of corticosteroids within 1 week before [177Lu]Lu-FF58
administration
Other protocol-defined inclusion/exclusion criteria may apply
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Stanford University .
Address:
City:
Palo Alto
Zip:
94304
Country:
United States
Facility:
Name:
Massachusetts General Hospital Massachusetts General Hospital
Address:
City:
Boston
Zip:
02114
Country:
United States
Facility:
Name:
BAMF Health Research
Address:
City:
Grand Rapids
Zip:
49503
Country:
United States
Facility:
Name:
MD Anderson Cancer Center Uni of Te MDACC.
Address:
City:
Houston
Zip:
77030
Country:
United States
Facility:
Name:
Novartis Investigative Site
Address:
City:
Tel Aviv
Zip:
6423906
Country:
Israel
Facility:
Name:
Novartis Investigative Site
Address:
City:
Reggio Emilia
Zip:
42123
Country:
Italy
Facility:
Name:
Novartis Investigative Site
Address:
City:
Nijmegen
Zip:
6500HB
Country:
Netherlands
Facility:
Name:
Novartis Investigative Site
Address:
City:
Hospitalet de LLobregat
Zip:
08907
Country:
Spain
Facility:
Name:
Novartis Investigative Site
Address:
City:
Madrid
Zip:
28034
Country:
Spain
Facility:
Name:
Novartis Investigative Site
Address:
City:
Geneve 14
Zip:
CH 1211
Country:
Switzerland
Start date:
October 6, 2023
Completion date:
January 26, 2027
Lead sponsor:
Agency:
Novartis Pharmaceuticals
Agency class:
Industry
Source:
Novartis
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05977322
