RecruitingPhase 1Phase 2NCT05706129

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

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


Sponsor

ITM Oncologics GmbH

Enrollment

270 participants

Start Date

Mar 14, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The main purpose of Part A of the study is to evaluate safety, tolerability and tracer uptake after a single intravenous (IV) administration of \[68Ga\]Ga-DPI-4452 for each tumor type such as clear cell renal cell cancer (ccRCC), pancreatic ductal adenocarcinoma (PDAC), and colorectal cancer (CRC); Part B: is to determine the recommended phase 2 dose (RP2D) \[maximum tolerated dose (MTD) or lower dose\] for \[177Lu\]Lu-DPI-4452 for each tumor type such as ccRCC, PDAC, CRC, and urothelial carcinoma (UC); Part C: is to evaluate the preliminary antitumor activity of \[177Lu\]Lu-DPI-4452 as monotherapy for each tumor type such as ccRCC, PDAC, CRC, and UC; Part D: is to assess the diagnostic concordance between \[68Ga\]Ga-DPI-4452 Positron Emission Tomography (PET) and the histopathology result of the Indeterminate Renal Mass (IDRM); Part E: is to assess \[68Ga\]Ga-DPI-4452 uptake in each tumour type such as UC, muscle invasive bladder cancer (MIBC), head and neck cancer (H\&N), triple negative breast cancer (TNBC), squamous non-small cell lung cancer (NSCLC), and any other tumor with locally confirmed carbonic anhydrase (CA) IX expression except ccRCC, CRC and PDAC.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new radioactive compound that can be used both to image tumors (using a PET scan with gallium-68) and to treat them (using a therapy version with lutetium-177), targeting a protein called carbonic anhydrase IX or related markers found in several cancer types. **You may be eligible if...** - You are 18 or older - You have advanced, unresectable kidney cancer (clear cell renal cell carcinoma) that has progressed after at least two lines of treatment including a TKI and an immune checkpoint inhibitor - OR you have advanced pancreatic ductal adenocarcinoma after at least one platinum or gemcitabine-based regimen - OR you have advanced colorectal cancer after standard chemotherapy regimens - You have at least one measurable tumor lesion - Tumor biopsy tissue is available for certain cancer types **You may NOT be eligible if...** - Your tumor type is not one of those listed in the study - You have not received the required prior treatments for your cancer type - You have significant organ dysfunction that prevents safe participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG[68Ga]Ga-DPI-4452

\[68Ga\]Ga-DPI-4452, administered as IV injection.

DRUG[177Lu]Lu-DPI-4452

\[177Lu\]Lu-DPI-4452, administered as IV infusion.


Locations(10)

Peter MacCallum Cancer Centre

Melbourne, Australia

UNSW Sydney, St Vincent's Hospital Sydney

Sydney, Australia

Centre Jean Perrin

Clermont-Ferrand, France

Centre Georges François Leclerc

Dijon, France

CHU de Grenoble-Alpes, Boulevard de la Chantourne

Grenoble, France

Centre Léon Bérard

Lyon, France

AP-HM - Hopital de la Timone

Marseille, France

CHU de Nantes

Nantes, France

IUCT - Oncopole

Toulouse, France

CHRU de Nancy - Hopitaux de Brabois

Vandœuvre-lès-Nancy, France

View Full Details on ClinicalTrials.gov

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NCT05706129


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