NCT05784597 (FAPrimo) is a Phase 1 clinical trial of [68Ga]Ga-OncoFAP administration in Breast Cancer, sponsored by Philogen S.p.A..

Who is sponsoring NCT05784597?

NCT05784597 is sponsored by Philogen S.p.A..

What drugs are being tested in NCT05784597?

Interventions in NCT05784597: [68Ga]Ga-OncoFAP administration.

What condition does NCT05784597 study?

NCT05784597 studies Breast Cancer, Colorectal Cancer, Oesophageal Cancer, Pancreas Adenocarcinoma.

Is NCT05784597 still recruiting?

NCT05784597 is currently completed. Last updated 15 November 2024.

Last reviewed 2024-11-15 · How we verify

NCT05784597: FAPrimo

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Last updated 15 November 2024

What this trial tests

Phase 1 trial testing [68Ga]Ga-OncoFAP administration in Breast Cancer in 18 participants. Completed in 21 October 2024.

Timeline

27 April 2023

Primary endpoint
21 October 2024

21 October 2024

Quick facts

Lead sponsor	Philogen S.p.A.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	18
Start date	27 April 2023
Primary completion	21 October 2024
Estimated completion	21 October 2024
Sites	5 locations across Italy

Drugs / interventions tested

[68Ga]Ga-OncoFAP administration — full drug profile →

Conditions studied

Breast Cancer — all drugs for Breast Cancer →
Colorectal Cancer — all drugs for Colorectal Cancer →
Oesophageal Cancer — all drugs for Oesophageal Cancer →
Pancreas Adenocarcinoma — all drugs for Pancreas Adenocarcinoma →

Sponsor

Philogen S.p.A. — full company profile →

Who can join

Adults 18 to 75, any sex, with Breast Cancer or Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Cancer-Associated Fibroblasts: Heterogeneity, Cancer Pathogenesis, and Therapeutic Targets.
Li Y, Liu Q, Jing X, Wang Y, et al · · 2025 · cited 11× · PMID 40656546 · DOI 10.1002/mco2.70292
Unveiling the Tumor Microenvironment Through Fibroblast Activation Protein Targeting in Diagnostic Nuclear Medicine: A Didactic Review on Biological Rationales and Key Imaging Agents.
Fouillet J, Torchio J, Rubira L, Fersing C. · · 2024 · cited 7× · PMID 39765634 · DOI 10.3390/biology13120967

Verify or expand the search:

Other recruiting trials for Breast Cancer

Currently open trials in the same condition.

NCT06148038 — CBD for Breast Cancer Primary Tumors · Phase 1 · recruiting
NCT07405801 — A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus R · Phase 2 · recruiting
NCT07285993 — Detection and Outcomes in Metastatic Invasive Lobular Breast Cancer Through Novel F-18 FAP PET · Phase 2 · recruiting
NCT07510698 — Same-Day Awake Mastectomy With Immediate Breast Reconstruction for Patients With Breast Cancer · NA · recruiting
NCT06768931 — Biolosion Combined Standard Neoadjuvant Therapy to Treat Triple-negative Breast Cancer · Phase 2 · recruiting

Other Philogen S.p.A. trials

Trials by the same sponsor.

NCT07120984 — A Study to Evaluate the Safety and Efficacy of L19TNF With Alkylating Chemotherapy for Patients With Recurrent IDH-mutan · Phase 2 · not yet recruiting
NCT06640413 — A Study to Evaluate the Safety and Preliminary Signs of Efficacy of [177Lu]Lu-OncoFAP-23 Alone or in Combination With L1 · Phase 1 · recruiting
NCT06840548 — A Study to Evaluate the Safety and Dosimetry of 68Ga-OncoCAIX in Patients With CAIX-positive Cancer · Phase 1 · completed
NCT06840535 — A Study to Evaluate the Safety and Dosimetry of 68Ga-OncoACP3 in Patients With Prostate Cancer · Phase 1 · completed
NCT05622175 — Safety and Preliminary Signs of Efficacy of F8IL10 for Intra-articular Treatment · Phase 1 · withdrawn

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05784597 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Philogen S.p.A.
Last refreshed: 15 November 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05784597.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing