Recruiting nowPhase 2
What this trial is trying to do
The researchers are testing whether a carbonic anhydrase IX (CAIX)-targeting compound can first be used with gallium-68 PET imaging to show where it accumulates, and then with lutetium-177 to deliver radioactive treatment to the tumour. The trial will assess safety, find a suitable dose, and look for early signs of tumour shrinkage or control in colorectal and other solid cancers.
The idea is that imaging could identify tumours reached by the drug, while the lutetium-linked version might treat those tumours without giving the same radiation exposure throughout the body. This non-randomised trial mainly measures side effects and dose, with preliminary antitumour activity rather than a comparison showing longer survival or longer control than standard treatment.
Worth knowing: It is an early, non-randomised study whose main outcome is safety, so it cannot establish whether the treatment is better than existing care.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
| Registry number | NCT05706129 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 2 |
| Design | not randomised, open label |
| Taking part | 270 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | Lumara Bio Oncologics GmbH |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug [68Ga]Ga-DPI-4452
- Drug [177Lu]Lu-DPI-4452
What it is measuring
Part A: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
Phase 2. Tests whether the treatment works well enough to be worth a larger trial. Usually too small to prove it changes survival.
How the researchers describe it
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.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Metastatic
- Locally advanced
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
Inclusion Criteria
Part A, B, and C:
- Written informed consent, dated and signed by the patient prior to any study-specific procedure.
- Part B and C are not conducted in the United States of America.
- Has histologically or cytologically confirmed, unresectable locally advanced or metastatic solid tumors of:
- Clear cell renal cell cancer (ccRCC) – participants must have received at least one line containing Tyrosine kinase inhibitor (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.
- Pancreatic ductal adenocarcinoma (PDAC) – participants must have received at least one line of platinum- and/or gemcitabine-based regimen.
- Colorectal cancer (CRC) – participants must have received at least one line of FOLFIRINOX or FOLFOX/FOLFIRI in two lines in combination with anti-Vascular Endothelial Growth Factor (VEGF) or anti-Epidermal Growth Factor Receptor (EGFR).
- Participants with CRC or PDAC: availability of fresh biopsy, OR an archival biopsy/surgical specimen of the tumor (preferably, taken after last prior line of therapy).
- For Part B and C only: Urothelial cancer (UC) patients must have received all available standard of care if eligible, including one line of platinum-based chemotherapy, enfortumab vedotin and pembrolizumab.
- Presence of at least 1…
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 10 sites. Listed in: Australia, France.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT05706129, registered by Lumara Bio Oncologics GmbH on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.