Trials / Recruiting
RecruitingNCT05706129
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
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 270 (estimated)
- Sponsor
- ITM Oncologics GmbH · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2023-03-14
- Primary completion
- 2027-06-01
- Completion
- 2029-03-01
- First posted
- 2023-01-31
- Last updated
- 2025-10-20
Locations
10 sites across 2 countries: Australia, France
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05706129. Inclusion in this directory is not an endorsement.