A Study to Evaluate the Safety and Dosimetry of 68Ga-labelled OncoFAP Derivatives in Solid Tumors

NCT05784597 | Completed Phase 1

• 1 other identifier: PH-FAPGA-01/22
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 5

Brief Summary

The primary objectives of this trial are to evaluate the safety and dosimetry of \[68Ga\]Ga-OncoFAP for detection/imaging of solid tumors.

Conditions

Breast Cancer; Colorectal Cancer; Oesophageal Cancer; Pancreas Adenocarcinoma

Outcome Measures

Primary Outcomes (3)

• Safety (AE)

  Safety of administration of 68Ga-OncoFAP, assessed based on Common Toxicity Criteria (CTCAE version 5.0)

  Throughout study, until a maximum of 8 days after the completion of each patient

• Cohort A: Dosimetry - Effective dose equivalent (mSv)

  Effective dose equivalent (mSv) of normal organs following administration of a single dose of \[68Ga\]Ga-OncoFAP, for patients in cohort A

  Assessed on day 1

• Cohort A: Dosimetry - Absorbed doses (mGy)

  Absorbed doses (mGy) of normal organs following administration of a single dose of \[68Ga\]Ga-OncoFAP, for patients in cohort A

  Assessed on day 1

Secondary Outcomes (7)

• Biodistribution profile: SUVmax

  Assessed on day 1

• Biodistribution profile: SUVmean

  Assessed on day 1

• Biodistribution profile: SUVsd

  Assessed on day 1

• PK

  Assessed on day 1

• Excretion

  Assessed on day 1

Study Arms (2)

Cohort A

EXPERIMENTAL

3 female + 3 male patients with a primary tumor only

Drug: [68Ga]Ga-OncoFAP administration

Cohort B

EXPERIMENTAL

Patients with a primary tumor and/or advanced/metastatic disease with a quantifiable number of lesions

Drug: [68Ga]Ga-OncoFAP administration

Interventions

[68Ga]Ga-OncoFAP administration DRUG

All patients will receive a single intravenous bolus administration of 250 MBq (225 - 275 MBq)

Cohort A; Cohort B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Requirement for diagnostic imaging or imaging performed within 4 weeks prior to the \[68Ga\]Ga-OncoFAP-PET/CT scan for staging.
• Male or non-pregnant and non-breastfeeding female.
• 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.
• For male patients: male subject able to father children must agree to practice effective contraception for three months starting from the study drug administration.
• Age 18 - 75
• ECOG ≤ 1
• Patient must not have any concomitant infections or active concomitant disease.
• Life expectancy of more than 12 weeks.
• Ability to undergo imaging study procedures.
• Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
• 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).

You may not qualify if:

• Chronically impaired renal function as expressed by creatinine clearance \< 60 mL/min or serum creatinine \> 1.5 x ULN.
• Presence of active hepatitis.
• 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).
• Pregnant or breastfeeding during participation in the study.
• 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.
• Serious, non-healing wound, ulcer, or bone fracture.
• Allergy to study medication or excipients in study medication.
• Any anti-cancer therapy (e.g. cytotoxic chemotherapy, immunotherapy, radiation, surgery, etc.) within 3 weeks before \[68Ga\]Ga-OncoFAP-PET/CT scan
• 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.

Sponsors & Collaborators

• Philogen S.p.A.: lead

Study Sites (5)

Istituto Nazionale dei Tumori | Fondazione IRCCS

Milan, Milano, 20133, Italy

Location

Istituto Clinico Humanitas

Rozzano, Milano, 20089, Italy

Location

Azienda Ospedaliero Universitaria Pisana

Pisa, Pisa, 56126, Italy

Location

IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori"

Meldola, 47014, Italy

Location

IRCCS San Raffaele

Milan, 20132, Italy

Location

MeSH Terms

Conditions

Breast Neoplasms; Colorectal Neoplasms; Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Head and Neck Neoplasms; Esophageal Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: December 15, 2022
• First Posted: March 27, 2023
• Study Start: April 27, 2023
• Primary Completion: October 21, 2024
• Study Completion: October 21, 2024
• Last Updated: November 15, 2024

Record last verified: 2024-11

Locations

IT (5)