Actively Recruiting
Study to Assess Safety, Tolerability, Imaging, and Efficacy of [68Ga]Ga-DPI-4452 and [177Lu]Lu-DPI-4452 in Patients With Unresectable Locally Advanced or Metastatic Solid Tumors
Led by ITM Oncologics GmbH · Updated on 2025-10-20
270
Participants Needed
10
Research Sites
91 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and imaging characteristics of the drug [68Ga]Ga-DPI-4452, as well as the safety, tolerability, and preliminary efficacy of [177Lu]Lu-DPI-4452 in participants with unresectable locally advanced or metastatic solid tumors. The study covers various tumor types including clear cell renal cell cancer, pancreatic ductal adenocarcinoma, colorectal cancer, urothelial carcinoma, muscle invasive bladder cancer, head and neck cancer, triple negative breast cancer, and squamous non-small cell lung cancer. The trial is a multicenter, open-label, non-randomized phase 1/2 study sponsored by ITM Oncologics GmbH. Participants receive intravenous administration of [68Ga]Ga-DPI-4452 as a single dose during screening or on Day 1, depending on the study part. In parts B and C, escalating doses of [177Lu]Lu-DPI-4452 are given by IV infusion on Day 1 of each cycle every 4 or 6 weeks, with the recommended phase 2 dose determined based on safety and tolerability. Different parts of the study assess safety, dose-limiting toxicities, antitumor activity, diagnostic imaging concordance, and tracer uptake in various tumor types. During the study, participants undergo various assessments including PET imaging scans, blood and urine sample collections at multiple time points to measure drug concentration, and evaluations of tumor lesions using established criteria. Safety is monitored by tracking treatment-emergent and serious adverse events, dose-limiting toxicities, and other clinical measures. The study may continue up to 81 months for long-term evaluation of tumor response, progression-free survival, and overall survival. Participants are followed closely with imaging and clinical assessments throughout the study duration.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent before any study procedures.
- Be aged 18 years or older.
- Have histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors including clear cell renal cell cancer, pancreatic ductal adenocarcinoma, colorectal cancer, urothelial carcinoma, or other specified tumors.
- Meet prior treatment requirements specific to tumor type, such as previous lines of therapy including tyrosine kinase inhibitors, immune checkpoint inhibitors, chemotherapy, or platinum-based regimens.
- Have at least one non-irradiated measurable tumor lesion documented within 4 weeks prior to [68Ga]Ga-DPI-4452 administration.
- For colorectal and pancreatic cancers, availability of recent or archival tumor biopsy samples.
- For Parts B and C, urothelial cancer patients must have received all available standard of care treatments if eligible.
- Participants in Part D must have imaging evidence of a single indeterminate renal mass of 7 cm or less, suspicious for clear cell renal cell cancer, and planned for nephrectomy or diagnostic procedure within 90 days.
- Participants in Part E must have histologically or cytologically confirmed progressive unresectable locally advanced or metastatic solid tumors with confirmed carbonic anhydrase IX expression, excluding certain tumor types.
You will not qualify if you...
- Any major surgery within 12 weeks before enrollment.
- Inability to remain still in the scanner with arms resting alongside the body or raised for the scan duration.
- Known hypersensitivity to the active substances, excipients of DPI-4452, or radiographic contrast agents.
- Bladder outflow obstruction or uncontrollable urinary incontinence.
- Unresolved clinically significant toxic effects from prior cancer therapy, surgery, or radiotherapy above Grade 1 (with specified exceptions).
- Prior administration of radiopharmaceuticals within defined time periods before study dosing.
- Previous treatment targeting carbonic anhydrase IX within specified time frames.
- Prior external beam radiation therapy to more than 25% of bone marrow.
- Active clinically significant cardiac disease or inflammatory bowel disease (for Parts B and C).
- Malignant diseases other than the one being treated, except for certain treated and stable malignancies.
- Ongoing treatment with certain blood-thinning medications within 2 weeks prior to dosing (for Part D).
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day 1
Participants receive a single dose of [68Ga]Ga-DPI-4452 administered as an IV injection for imaging assessment.
1 visit (in-person)
Duration - Repeated 28-day or 42-day cycles depending on dosing schedule
Participants receive escalating or recommended doses of [177Lu]Lu-DPI-4452 administered as an IV infusion on Day 1 of each cycle to assess safety, tolerability, and efficacy.
1 visit per cycle (in-person) on Day 1
Duration - Up to 81 months
Participants are monitored for treatment-emergent adverse events, response to treatment, and survival outcomes after completing treatment.
Periodic visits depending on treatment response and study schedule
Trial Site Locations
Total: 10 locations
1
Peter MacCallum Cancer Centre
Melbourne, Australia, VIC 3000
Actively Recruiting
2
UNSW Sydney, St Vincent's Hospital Sydney
Sydney, Australia, NSW 2010
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3
Centre Jean Perrin
Clermont-Ferrand, France, 63011
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4
Centre Georges François Leclerc
Dijon, France, 21079
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5
CHU de Grenoble-Alpes, Boulevard de la Chantourne
Grenoble, France, 38043
Actively Recruiting
6
Centre Léon Bérard
Lyon, France, 69373
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7
AP-HM - Hopital de la Timone
Marseille, France, 13005
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8
CHU de Nantes
Nantes, France, 44093
Actively Recruiting
9
IUCT - Oncopole
Toulouse, France, 31100
Actively Recruiting
10
CHRU de Nancy - Hopitaux de Brabois
Vandœuvre-lès-Nancy, France, 54511
Actively Recruiting
Research Team
I
ITM Oncologics GmbH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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