DEBIO 1228-101 PART A (Phase I)

Investigator physician: Pr Pierre OLIVIER

A multicenter, open-label, non-randomized Phase 1/2 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 patients with unresectable locally advanced or metastatic solid tumors

Histologically or cytologically confirmed, unresectable locally advanced or metastatic solid tumors of:
- ccRCC: patients must have received at least one line containing TKI treatment and at least one line containing Immune Checkpoint Inhibitor treatment in metastatic setting, meaning at least two lines of treatment in metastatic setting; or
- PDAC: patients must have received at least one line of platinum- and/or gemcitabine-based regimen; or
- CRC: patients must have received at least one line of FOLFIRINOX or FOLFOX/FOLFIRI in two lines in combination with anti-VEGF or anti-EGFR

The DEBIO study is a Phase I/II, 3-part A, B and C trial of MRP ⁶⁸Ga-DPI-4452 for diagnosis and MRP ¹⁷⁷Lu-DPI-4452 for therapy, in patients with unresectable locally advanced or metastatic solid tumors belonging to the following 3 tumor types: clear cell renal cell carcinoma (CCRC), pancreatic duct carcinoma (PDC) and colorectal cancer (CRC).

Several radioligand-targeted therapies in oncology have shown a more favorable benefit-risk ratio than other anti-cancer therapies. The DEBIO study focuses on a protein known as carbonic anhydrase IX or CA IX. This enzyme or protein is widely expressed in solid malignant tumors, and possesses the ability to bind easily to various radionuclides through an organic compound called DOTA cage. The MRP under study can be considered a promising vector for a theranostic approach with imaging and therapy in cancers expressing CA IX.

Part B is a dose escalation to define the recommended dose and evaluate the safety, tolerability, pharmacokinetics, dosimetry and preliminary tumor activity of ¹⁷⁷Lu-DPI-4452, initially in CRCCs only.
Once the recommended dose has been reached, the CRC and CCP cohorts will be opened.

Part C focuses on 90 patients (phase II study) to verify the safety and tolerability of the product in the 3 cohorts.

Thérapy : [¹⁷⁷Lu]Lu-DPI-4452
Study status: Recruiting
Clinical Trial number: NCT05706129
Funding: