NCT05432193

FAPi Radioligand OpeN-Label, Phase 1 Study to Evaluate Safety, Tolerability and DosImetry of [Lu-177]-PNT6555; A Dose Escalation Study for TReatment of Patients With Select Solid Tumors (FRONTIER)

Terminated Phase 1 Last updated 25 June 2025

What this trial tests

Phase 1 trial testing [Ga-68]-PNT6555 in Pancreatic Ductal Adenocarcinoma in 20 participants. Terminated before completion.

Timeline

13 July 2022

Primary endpoint
10 November 2023

2 October 2024

Quick facts

Lead sponsor	POINT Biopharma, a wholly owned subsidiary of Eli Lilly and Company
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	13 July 2022
Primary completion	10 November 2023
Estimated completion	2 October 2024
Sites	4 locations across Canada, United States

Drugs / interventions tested

• [Ga-68]-PNT6555 — full drug profile →
• [Lu-177]-PNT6555 — full drug profile →

Conditions studied

• Pancreatic Ductal Adenocarcinoma — all drugs for Pancreatic Ductal Adenocarcinoma →
• Colorectal Cancer — all drugs for Colorectal Cancer →
• Esophageal Cancer — all drugs for Esophageal Cancer →
• Melanoma (Skin) — all drugs for Melanoma (Skin) →

Sponsor

POINT Biopharma, a wholly owned subsidiary of Eli Lilly and Company — full company profile →

Who can join

18 and older, any sex, with Pancreatic Ductal Adenocarcinoma or Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This Phase 1 study will evaluate the safety and tolerability of \[Ga-68\]-PNT6555 and \[Lu-177\]-PNT6555 in subjects with select solid tumors that have FAP over-expression, in order to determine a recommended Phase 2 dose.

Publications & conference data

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

1. Fibroblast activation protein-targeted radionuclide therapy: background, opportunities, and challenges of first (pre)clinical studies.
   Privé BM, Boussihmad MA, Timmermans B, van Gemert WA, et al · · 2023 · cited 139× · PMID 36813980 · DOI 10.1007/s00259-023-06144-0
2. Targeted Alpha-Particle Therapy: A Review of Current Trials.
   Jang A, Kendi AT, Johnson GB, Halfdanarson TR, et al · · 2023 · cited 59× · PMID 37511386 · DOI 10.3390/ijms241411626
3. Cancer-associated fibroblasts as therapeutic targets for cancer: advances, challenges, and future prospects.
   Cao Z, Quazi S, Arora S, Osellame LD, et al · · 2025 · cited 57× · PMID 39780187 · DOI 10.1186/s12929-024-01099-2
4. Peptide Drug Conjugates and Their Role in Cancer Therapy.
   Heh E, Allen J, Ramirez F, Lovasz D, et al · · 2023 · cited 54× · PMID 36614268 · DOI 10.3390/ijms24010829
5. Theranostics - a sure cure for cancer after 100 years?
   Song Y, Zou J, Castellanos EA, Matsuura N, et al · · 2024 · cited 32× · PMID 38646648 · DOI 10.7150/thno.96675
6. From basic research to clinical application: targeting fibroblast activation protein for cancer diagnosis and treatment.
   Zhang Z, Tao J, Qiu J, Cao Z, et al · · 2024 · cited 21× · PMID 37726505 · DOI 10.1007/s13402-023-00872-z
7. Therapeutic potential of FAPI RLT in oncology: A systematic review.
   Ruzzeh S, Abdlkadir AS, Paez D, Kang KW, et al · · 2025 · cited 18× · PMID 40213678 · DOI 10.7150/thno.106108
8. Overcoming cancer treatment resistance: Unraveling the role of cancer-associated fibroblasts.
   Wang X, Zhou Y, Wang Y, Yang J, et al · · 2025 · cited 13× · PMID 40693233 · DOI 10.1016/j.jncc.2025.03.002