ITM-91 / Debiopharm, 3B Pharma, ITM Isotopen Technologien Munchen - LARVOL DELTA

[68Ga]Ga-DPI-4452 PET/CT for staging of patients with clear cell renal cell carcinoma (ESMO 2025) - "In 14 pts, most CAIX-positive regions showed SUVmax >20, suggesting investigation of potential therapy with [177Lu]Lu-DPI-4452...High SUV values indicate potential for a theranostic application. Legal entity responsible for the study University Hospital Essen."

Clinical • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Solid Tumor • CA9

GaLuCi: 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) - P1/2 | N=270 | Recruiting | Sponsor: Debiopharm International SA | N=170 ➔ 270

Enrollment change • Bladder Cancer • Breast Cancer • Clear Cell Renal Cell Carcinoma • Colorectal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Renal Cell Carcinoma • Solid Tumor • Triple Negative Breast Cancer • Urothelial Cancer • EGFR

ITM Obtains Exclusive Worldwide License from Debiopharm for CA IX-Targeted Peptide-based Radiopharmaceutical Programs Targeting Solid Tumors (GlobeNewswire) - "ITM Isotope Technologies Munich SE...announced that the companies entered an agreement under which ITM gains the exclusive global license for the clinical and commercial development of the peptide-based, theranostic pair ITM-91/ITM-94D, formerly Debio 0228/0328, targeting the Carbonic Anhydrase IX (CA IX) surface protein...The theranostic pair is being investigated in the phase 1/2 GaLuCi (NCT05706129) clinical trial in patients living with locally advanced ccRCC, PDAC and CRC...'We look forward to advancing the GaLuCi trial and to building the optimal clinical strategy for this molecule.'...As the globally leading manufacturer of n.c.a. Lutetium-177 and with a broad pipeline of radiopharmaceutical diagnostic and therapeutic candidates, ITM will use its production capabilities and clinical expertise to advance this theranostic pair."

Licensing / partnership • Trial status • Colorectal Cancer • Pancreatic Ductal Adenocarcinoma • Renal Cell Carcinoma

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) - P1/2 | N=170 | Recruiting | Sponsor: Debiopharm International SA | Trial completion date: Jan 2027 ➔ Mar 2029 | Trial primary completion date: Jan 2026 ➔ Jun 2027

Metastases • Trial completion date • Trial primary completion date • Clear Cell Renal Cell Carcinoma • Colorectal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Renal Cell Carcinoma • Solid Tumor • EGFR

Preclinical Characterization of DPI-4452: A 68Ga/177Lu Theranostic Ligand for Carbonic Anhydrase IX. (PubMed, J Nucl Med) - "[177Lu]Lu-DPI-4452 demonstrated strong tumor growth inhibition in 2 xenograft mouse models. Thus, the 2 agents potentially provide a theranostic approach for selecting and treating patients with CAIX-expressing tumors such as ccRCC, CRC, and pancreatic ductal adenocarcinoma."

Journal • Preclinical • Clear Cell Renal Cell Carcinoma • Colorectal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • Von Hippel-Lindau Syndrome • CA9 • VHL

First-in-Human Safety, Imaging, and Dosimetry of a Carbonic Anhydrase IX-Targeting Peptide, [68Ga]Ga-DPI-4452, in Patients with Clear Cell Renal Cell Carcinoma. (PubMed, J Nucl Med) - "[68Ga]Ga-DPI-4452, a first-in-class carbonic anhydrase IX-binding radiolabeled peptide, is the imaging agent of a theranostic pair with [177Lu]Lu-DPI-4452, developed for selecting and treating patients with carbonic anhydrase IX-expressing tumors...No clinically significant toxicity was observed. [68Ga]Ga-DPI-4452 showed exceptional tumor uptake in patients with clear cell renal cell carcinoma, with very high tumor-to-background ratios and no significant adverse events, suggesting potential diagnostic and patient selection applications."

Journal • P1 data • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Solid Tumor • CA9

First-in-human safety, imaging and dosimetry of [68Ga]Ga-DPI-4452, a novel CA IX-targeting peptide, in patients with clear cell renal cell carcinoma. (ASCO-GU 2024) - P1/2 | "[68Ga]Ga-DPI-4452 provides exceptional images in patients with ccRCC without clinically significant toxicity. Very high SUVs and tumor-to-background ratios suggest potential for use in both diagnostics and patient selection for therapy. The tumor retention and rapid elimination support potential of [177Lu]Lu-DPI-4452 radioligand therapy."

Clinical • P1 data • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • CA9

First-in-human clinical trial design of a first-in-class theranostic approach with a peptide-based radioligand targeting CA IX-expressing tumors. (ASCO 2023) - P1/2 | "Radiolabeling DPI-4452 with gallium-68 ([68Ga]Ga-DPI-4452) or lutetium-177 ([177Lu]Lu-DPI-4452) is an innovative theranostic approach for identifying and treating patients (pts) with CA IX-expressing tumors...Eur J Nucl Med Mol Imaging 2022;49(Suppl 1):S1–S751. Clinical trial information: NCT05706129."

Clinical • P1 data • Clear Cell Renal Cell Carcinoma • Colorectal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Renal Cell Carcinoma • Solid Tumor • Von Hippel-Lindau Syndrome • CA9 • VHL

DEBIOPHARM ANNOUNCES LAUNCH OF THE PHASE 1/2 GaLuCi STUDY FOR ITS CA IX-TARGETED RADIOPHARMACEUTICAL PROGRAM (PRNewswire-Asia) - "Debiopharm...announced the first patient dosed of their first-in-human, phase 1/2 study, GaLuCi™. The first patient was screened and dosed at the Australian-based Peter MacCallum Cancer Centre. This multicenter international trial, evaluating a radioligand theranostic pair will be carried out in three stages: Part A to confirm the safety and reliability of Debio 0328 in detecting CA IX-expressing solid tumors, Part B to assess escalating doses of the therapeutic agent, Debio 0228 in patients, whose tumors show high uptake of Debio 0328 and finally, based on the recommended dose from part B, Part C will further assess safety and preliminary efficacy in selected tumor types."

Trial status • Clear Cell Renal Cell Carcinoma • Colorectal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Kidney Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Renal Cell Carcinoma • Solid Tumor

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) - P1/2 | N=147 | Recruiting | Sponsor: Debiopharm International SA | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Clear Cell Renal Cell Carcinoma • Colorectal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Renal Cell Carcinoma • Solid Tumor