NCT06840548

A Study to Evaluate the Safety and Dosimetry of 68Ga-OncoCAIX in Patients With CAIX-positive Cancer

A Phase I Study to Evaluate the Safety and Dosimetry of 68Ga-OncoCAIX in Patients With CAIX-positive Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Philogen S.p.A. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase I and multicenter study to evaluate the safety and dosimetry of 68Ga-OncoCAIX in patients with clear cell renal cell carcinoma.

Detailed description

The Carbonic Anhydrase IX (CAIX) is a clinically validated marker of clear-cell renal cell carcinoma (ccRCC) and hypoxic tumors. OncoCAIX is a new ligand for CAIX. This is a Phase I, multicenter study in patients with suspected ccRCC to evaluate the safety, dosimetry and biodistribution of 68Ga-OncoCAIX for imaging of ccRCC. In this trial, 68Ga-OncoCAIX is offered to ccRCC patients who already received standard of care imaging and might therefore complement available modalities. All patients will undergo PET/CT imaging with \[68Ga\]Ga-OncoCAIX. The principal objective of the study is to evaluate safety and dosimetry of a single administration of \[68Ga\]Ga-OncoCAIX. In addition, data on the uptake, biodistribution, PK and excretion of \[68Ga\]Ga-OncoCAIX is collected and technical parameters are evaluated. Patients are divided into two cohorts: * Cohort A: 3 female + 3 male patients without visceral or bone metastases, which would interfere with dosimetry evaluation of healthy organs. * Cohort B: all patients who meet the eligibility criteria (up to 14 patients) Both cohorts are recruited in parallel, and patients are assigned to the respective cohort based on their disease extent. Whenever possible, patients are enrolled in cohort A, unless they are unsuitable for cohort A, or the required number of patients of a given sex has already been enrolled in cohort A. All patients will receive a single intravenous bolus administration of \[68Ga\]Ga-OncoCAIX and biodistribution, PK, and dosimetry of \[68Ga\]Ga-OncoCAIX will be assessed based on a series of PET/CT scans, blood and urine sampling. Full dosimetry evaluations will be performed for all patients in cohort A. Additional dosimetry in the other patients may be performed to the extent that it is possible based on their disease burden (i.e., only organs not affected by malignant lesions can be evaluated). All patients will be assessed for safety. In addition, relative uptake to appropriate reference tissue of \[68Ga\]Ga-OncoCAIX as well as semiquantitative parameters such as SUVmax/SUVmean/SUVsd, are determined. The correlation of \[68Ga\]Ga-OncoCAIX uptake with immunopathology staining for CAIX will be evaluated in patients undergoing surgery or tumor biopsy collection. The lesion detection rate will be compared to 18F-FDG-PET/CT in patients who receive this as part of their standard diagnostic workup.

Conditions

• Clear Cell Renal Cell Carcinoma (ccRCC)

Interventions

Type	Name	Description
DRUG	[68Ga]Ga-OncoCAIX	Single intravenous bolus administration.

Timeline

• Start date: 2025-04-16
• Primary completion: 2025-11-28
• Completion: 2025-11-28
• First posted: 2025-02-21
• Last updated: 2026-01-13

Locations

3 sites across 1 country: Italy