FDA grants fast track designation to diagnostic agent for clear cell renal cell carcinoma

The FDA has granted fast track designation to [68Ga]Ga-DPI-4452 (ITM-94), a PET imaging agent for the detection of clear cell renal cell carcinoma (ccRCC), ITM announced in a news release.¹

Fast track designation is awarded to novel agents that are intended to treat or prevent serious or life-threatening conditions and have the potential to address an unmet medical need. With this designation, the development process for [68Ga]Ga-DPI-4452 can benefit from more frequent engagement with the FDA as well as eligibility for accelerated approval and priority review.

“The FDA’s Fast Track designation is a validation of ITM-94’s potential to aid in the non-invasive diagnosis of renal cell carcinoma,” noted Celine Wilke, MD, chief medical officer of ITM, in the news release.¹

[68Ga]Ga-DPI-4452 is a gallum-68-radiolabeled PET imaging agent. The agent forms a theranostic pair with the therapeutic candidate, [177Lu]Lu-DPI-4452 (ITM-91), which targets carbonic anhydrase IX (CAIX) in ccRCC.

The theranostic pair of ITM-91/ITM-94 is currently under investigation in an ongoing, open-label phase 1/2 trial (NCT05706129) in patients with locally advanced or metastatic solid tumors, including ccRCC. Patients are being enrolled in the study through clinical trial sites in Australia and France.²

The study is being conducted in 4 parts. Part A assessed the safety and tolerability of IV administration of [68Ga]Ga-DPI-4452 in patients with solid tumors. Findings from this portion of the study showed a high tumor-to-background ratio and favorable tolerability in patients with confirmed ccRCC. Part B of the study is assessing increasing doses of the therapeutic agent, ITM-91, in patients with high CAIX expression per imaging with ITM-94. Part C will evaluate the safety and preliminary efficacy of ITM-91 at the recommended dose and treatment schedule obtained from part B. Part D of the trial is also ongoing to assess the effectiveness of ITM-94 vs CT/MRI imaging in accurately detecting ccRCC in patients with an indeterminate renal mass (IDRM).

Patients were eligible for enrollment in Part D of the study if they had an IDRM of 7 cm or smaller in the largest diameter (tumor stage cT1) that was suspicious for ccRCC and planned for partial nephrectomy, cystoscopy and retrograde pyelography, or biopsy.

The primary end point for Part D is the concordance between [68Ga]Ga-DPI-4452 PET imaging and histopathology. Secondary end points in the study include the agent’s sensitivity, specificity, positive predictive value, and negative predictive value compared with histology.

Primary completion of the trial is expected in June 2027.

“We have seen promising data in our ongoing clinical trial that suggest ITM-94 could change how clinicians diagnose and stage patients across the broader ccRCC disease landscape, with potential utility in supporting clinical decision-making for indeterminate renal masses as well,” Wilke concluded in the news release on the fast track designation.¹ “This news highlights the innovation within our pipeline and the important role an effective diagnostic can play in cancer treatment.”

REFERENCES

1. ITM receives U.S. FDA fast track designation for ITM-94 as a diagnostic agent for clear cell renal cell carcinoma. News release. ITM Isotope Technologies Munich SE. November 17, 2025. Accessed November 17, 2025. https://www.biospace.com/press-releases/itm-receives-u-s-fda-fast-track-designation-for-itm-94-as-a-diagnostic-agent-for-clear-cell-renal-cell-carcinoma

2. A study to assess safety, tolerability and imaging characteristics of [68Ga]Ga-DPI-4452 and to assess safety, tolerability, and efficacy of [177Lu]Lu-DPI-4452 in participants with unresectable locally advanced or metastatic solid tumors. ClinicalTrials.gov. Last updated October 20, 2025. Accessed November 17, 2025. https://clinicaltrials.gov/study/NCT05706129