NCT05633160: COMBAT

64Cu-SAR-BBN and 67CU SAR-BBN for Identification and Treatment of Gastrin Releasing Peptide Receptor (GRPR)-Expressing Metastatic Castrate Resistant Prostate Cancer in Patients Who Are Ineligible for Therapy With 177Lu-PSMA-617 (COMBAT)

Terminated Phase 1, PHASE2 Last updated 29 August 2025

What this trial tests

Phase 1, PHASE2 trial testing 64Cu-SAR-BBN in Prostatic Neoplasms in 4 participants. Terminated before completion.

Timeline

15 June 2023

Primary endpoint
23 April 2025

23 April 2025

Quick facts

Lead sponsor	Clarity Pharmaceuticals Ltd
Phase	Phase 1, PHASE2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	4
Start date	15 June 2023
Primary completion	23 April 2025
Estimated completion	23 April 2025
Sites	6 locations across United States

Drugs / interventions tested

• 64Cu-SAR-BBN — full drug profile →
• 67Cu-SAR-BBN — full drug profile →

Conditions studied

• Prostatic Neoplasms — all drugs for Prostatic Neoplasms →
• Castration-Resistant — all drugs for Castration-Resistant →

Sponsor

Clarity Pharmaceuticals Ltd — full company profile →

Who can join

18 and older, male only, with Prostatic Neoplasms or Castration-Resistant. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The aim for this study is to determine the safety and efficacy of 67Cu-SAR-BBN in participants with Gastrin Releasing Peptide Receptor (GRPR)-expressing metastatic castrate resistant prostate cancer in patients who are ineligible for therapy with 177Lu-PSMA-617.

Publications & conference data

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

1. GRPR-targeting radiotheranostics for breast cancer management.
   D'Onofrio A, Engelbrecht S, Läppchen T, Rominger A, et al · · 2023 · cited 21× · PMID 38020178 · DOI 10.3389/fmed.2023.1250799
2. Radiopharmaceuticals for Cancer Diagnosis and Therapy: New Targets, New Therapies-Alpha-Emitters, Novel Targets.
   Taunk NK, Escorcia FE, Lewis JS, Bodei L. · · 2024 · cited 8× · PMID 38753757 · DOI 10.1097/ppo.0000000000000720
3. Radiolabeling Diaminosarcophagine with Cyclotron-Produced Cobalt-55 and [<sup>55</sup>Co]Co-NT-Sarcage as a Proof of Concept in a Murine Xenograft Model.
   Lin W, Fonseca Cabrera GO, Aluicio-Sarduy E, Barnhart TE, et al · · 2024 · cited 6× · PMID 38411531 · DOI 10.1021/acs.bioconjchem.4c00043
4. Radioligand Therapy in Cancer Management: A Global Perspective.
   Ninatti G, Lee ST, Scott AM. · · 2025 · cited 5× · PMID 41228206 · DOI 10.3390/cancers17213412
5. Emerging PET Imaging Agents and Targeted Radioligand Therapy: A Review of Clinical Applications and Trials.
   Palihati M, Das JP, Yeh R, Capaccione K. · · 2025 · cited 5× · PMID 40863874 · DOI 10.3390/tomography11080083
6. Evaluation of VLA-4 (Integrin α4β1) as a Shared Target for Radiopharmaceutical Therapy across Solid Tumors.
   Reyes-González JM, Rajkumar H, Lee W, Baidoo KE, et al · · 2025 · cited 3× · PMID 39911068 · DOI 10.1158/1535-7163.mct-24-0370
7. Positron Emission Tomography Radiotracers for Identification of Site of Recurrence in Prostate Cancer After Primary Treatment Failure.
   Bitar R, Zurita P, Martiniova L, Zurita AJ, et al · · 2025 · cited 1× · PMID 40427220 · DOI 10.3390/cancers17101723
8. <i>CopperNostics</i>-Here We Are Now, Entertain Us!
   Brühlmann SA, Walther M, Kopka K, Kreller M, et al · · 2026 · PMID 41754861 · DOI 10.3390/ph19020321