Trial Title:
A Study to Evaluate the Safety and Dosimetry of 68Ga-labelled OncoFAP Derivatives in Solid Tumors
NCT ID:
NCT05784597
Condition:
Breast Cancer
Colorectal Cancer
Oesophageal Cancer
Pancreas Adenocarcinoma
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Patients are divided into two cohorts:
- Cohort A: 3 female + 3 male patients with a primary tumor only
- Cohort B: patients with a primary tumor and/or advanced/metastatic disease with a
quantifiable number of lesions (6 - 14 patients)
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
[68Ga]Ga-OncoFAP administration
Description:
All patients will receive a single intravenous bolus administration of 250 MBq (225 - 275
MBq)
Arm group label:
Cohort A
Arm group label:
Cohort B
Summary:
The primary objectives of this trial are to evaluate the safety and dosimetry of
[68Ga]Ga-OncoFAP for detection/imaging of solid tumors.
Detailed description:
Phase I, multicenter study in patients with a confirmed diagnosis of solid tumor among
breast cancer, colorectal cancer, oesophageal cancer and pancreatic adenocarcinoma,
requiring clinical staging for nodal staging and/or metastatic disease (based on
institutional practice and risk stratification). All patients will receive a single
intravenous bolus administration of 250 MBq (225 - 275 MBq). [68Ga]Ga-OncoFAP
biodistribution, PK, and dosimetry of [68Ga]Ga-OncoFAP will be assessed based on a series
of PET/CT scans, blood and urine sampling.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patients with a confirmed diagnosis of breast cancer, colorectal cancer, oesophageal
cancer and pancreatic adenocarcinoma. Confirmation by histopathology is required for
breast, colorectal and oesophageal cancer. For pancreatic adenocarcinoma,
confirmation by histopathology or cytology obtained by endoscopic ultrasound is
accepted.
2. Requirement for diagnostic imaging or imaging performed within 4 weeks prior to the
[68Ga]Ga-OncoFAP-PET/CT scan for staging.
3. Male or non-pregnant and non-breastfeeding female.
4. For female patients: negative serum pregnancy test for women of childbearing
potential* (WOCBP).
WOCBP must agree to use, from the screening to six months following the study drug
administration, highly effective contraception methods, as defined by the
"Recommendations for contraception and pregnancy testing in clinical trials" issued
by the Head of Medicine Agencies' Clinical Trial Facilitation Group
(www.hma.eu/ctfg.html) and which include, for instance, progesterone-only or
combined (estrogen- and progesterone-containing) hormonal contraception associated
with inhibition of ovulation, intrauterine devices, intrauterine hormone-releasing
systems, bilateral tubal occlusion or vasectomized partner.
5. For male patients: male subject able to father children must agree to practice
effective contraception for three months starting from the study drug
administration.
6. Age 18 - 75
7. ECOG ≤ 1
8. Patient must not have any concomitant infections or active concomitant disease.
9. Life expectancy of more than 12 weeks.
10. Ability to undergo imaging study procedures.
11. Evidence of a personally signed and dated informed consent document indicating that
the subject has been informed of all pertinent aspects of the study.
12. Willingness and ability to comply with the scheduled visits, plan, laboratory tests
and other study procedures.
- Women of childbearing potential are defined as females who have experienced
menarche, are not postmenopausal (12 months with no menses without an
alternative medical cause) and are not permanently sterilized (e.g., tubal
occlusion, hysterectomy, bilateral oophorectomy, or bilateral salpingectomy).
Exclusion Criteria:
1. Chronically impaired renal function as expressed by creatinine clearance < 60 mL/min
or serum creatinine > 1.5 x ULN.
2. Presence of active hepatitis.
3. Presence of significant cardiac disorders (congestive heart failure, NYHA class
III-IV, myocardial infarction within one year prior to study entry, uncontrolled
hypertension, or arrhythmia).
4. Pregnant or breastfeeding during participation in the study.
5. Any concomitant condition which in the opinion of investigators makes it undesirable
for the patient to participate in the study or which could jeopardize compliance
with the protocol.
6. Major trauma including major surgery (such as abdominal/cardiac/thoracic surgery)
within 4 weeks of administration of the study drug. Minimally invasive procedures
such as biopsies are not considered as exclusion criteria.
7. Serious, non-healing wound, ulcer, or bone fracture.
8. Allergy to study medication or excipients in study medication.
9. Any anti-cancer therapy (e.g. cytotoxic chemotherapy, immunotherapy, radiation,
surgery, etc.) within 3 weeks before [68Ga]Ga-OncoFAP-PET/CT scan
10. Subject has received, or is scheduled to receive, another investigational medicinal
product (IMP) from 1 month before [68Ga]Ga-OncoFAP injection to end of study
participation.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Istituto Clinico Humanitas
Address:
City:
Rozzano
Zip:
20089
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Marcello Rodari, Dr.
Facility:
Name:
IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori"
Address:
City:
Meldola
Zip:
47014
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Federica Matteucci, Dr.
Facility:
Name:
IRCCS San Raffaele
Address:
City:
Milano
Zip:
20132
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Arturo Chiti, Dr.
Facility:
Name:
Istituto Nazionale dei Tumori | Fondazione IRCCS
Address:
City:
Milano
Zip:
20133
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Margarita Kirienko, Dr.
Facility:
Name:
Azienda Ospedaliero Universitaria Pisana
Address:
City:
Pisa
Zip:
56126
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Pinuccia Faviana, Dr.
Start date:
April 27, 2023
Completion date:
October 2024
Lead sponsor:
Agency:
Philogen S.p.A.
Agency class:
Industry
Source:
Philogen S.p.A.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05784597
