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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

NCT05706129 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2025-10-20

No results posted yet for this study

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.

Conditions

  • Clear Cell Renal Cell Cancer (ccRCC)
  • Pancreatic Ductal Adenocarcinoma (PDAC)
  • Colorectal Cancer (CRC)
  • Urothelial Carcinoma (UC)
  • Indeterminate Renal Mass (IDRM)
  • Muscle Invasive Bladder Cancer (MIBC)
  • Head and Neck Cancer (H&N)
  • Triple Negative Breast Cancer (TNBC)
  • Squamous Non-Small Cell Lung Cancer (NSCLC)

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.

Sponsors & Collaborators

  • ITM Oncologics GmbH

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-14
Primary Completion
2027-06-30
Completion
2029-03-31
FDA Drug
Yes

Countries

  • Australia
  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05706129 on ClinicalTrials.gov