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Clear Cell Renal Cell Cancer (ccRCC)Phase 1/2NCT05706129

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 Phase 1/2 study testing [68Ga]Ga-DPI-4452 and [177Lu]Lu-DPI-4452 in people with Clear Cell Renal Cell Cancer (ccRCC) and Pancreatic Ductal Adenocarcinoma (PDAC), run by Lumara Bio Oncologics GmbH at 10 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
[68Ga]Ga-DPI-4452 and [177Lu]Lu-DPI-4452
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
270 participants
Where
10 sitesin 2 countries
Study dates
14 Mar 2023to Mar 2029
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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 non-irradiated tumor lesion detected at conventional imaging (computed tomography / magnetic resonance imaging (CT/MRI)) documented within 4 weeks prior to the [68Ga]Ga-DPI-4452 administration.
  • Measurable disease per response evaluation criteria in solid tumors (RECIST) v1.1.
  • Part D:
  • Participants with imaging evidence of a single indeterminate renal mass (IDRM) of ≤ 7 cm in largest diameter (tumor stage cT1) on any conventional diagnostic imaging technique, suspicious for ccRCC and planned for total or partial nephrectomy, or interventional diagnostic (cystoscopy and retrograde pyelography or biopsy) within 90 days from planned [68Ga]Ga-DPI-4452 administration.
  • Part E:
  • Regardless of lines of treatment, participants with histologically or cytologically confirmed progressive, unresectable locally advanced or metastatic solid tumors of
  • UC, including MIBC
  • H\&N cancer
  • TNBC
  • Squamous NSCLC
  • Any other indication with confirmed carbonic anhydrase IX (CA IX) expression excluding ccRCC, PDAC and CRC, upon Sponsor agreement.
  • Presence of at least 1 non-irradiated tumor lesion detected at conventional imaging (CT/MRI) documented within 4 weeks prior to the [68Ga]Ga-DPI-4452 administration (for scans dated more than 4 weeks prior to D1, the Sponsor should be contacted to assess conventional imaging suitability)

Who cannot join

  • Any major surgery within 12 weeks before enrolment.
  • Inability to stay in the scanner bed with the arms resting out of the thoracic and abdominal fields (i.e., arms alongside the body or raised arm position) for the duration of the scan.
  • Part A:
  • Has known hypersensitivity to the active substance, to any of the excipients of the DPI-4452, or to radiographic contrast agents.
  • Bladder outflow obstruction or unmanageable urinary incontinence.
  • Participants who have not had resolution of clinically significant toxic effects of prior systemic cancer therapy, surgery, or radiotherapy to Grade ≤1 (except for laboratory parameters specified above, Grade 2 alopecia, and/or stable Grade 2 sensory neuropathy, according to National Cancer Institute Common Terminology Criteria for Adverse Events [NCI-CTCAE]).
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  • Administration of a radiopharmaceutical within a period corresponding to 10 half-lives of the radionuclide used prior to injection of [68Ga]Ga-DPI-4452.
  • Previous Carbonic anhydrase (CA) IX-targeting treatment.
  • Prior external beam radiation therapy (EBRT) to more than 25% of the bone marrow, as judged by the Investigator.
  • Part B and Part C:
  • Known hypersensitivity to the active substance, to any of the excipients of the DPI-4452, or to radiographic contrast agents.
  • Bladder outflow obstruction or unmanageable urinary incontinence.
  • Participants who have not had resolution of clinically significant toxic effects of prior systemic cancer therapy, surgery, active clinically significant cardiac disease, or radiotherapy to Grade ≤1 (except for laboratory parameters specified above, Grade 2 alopecia, or stable Grade 2 sensory neuropathy, according to NCI-CTCAE).
  • Administration of a radiopharmaceutical with therapeutic intent within a period of 6 months prior to injection of [68Ga]Ga-DPI-4452.
  • Any previous CA IX-targeting treatment for non-oncological indication within 3 months prior to the [177Lu]Lu-DPI-4452 infusion; any previous CA IX-targeting treatment for any oncological indication.
  • Participants who received any systemic antineoplastic therapy for the underlying disease and/or other investigational agents within a period which is ≤5 half-lives or ≤4 weeks (whichever is shorter).
  • Inflammatory bowel disease (e.g Crohn's disease, ulcerative colitis, etc).
  • Part D:
  • Known hypersensitivity to the active substance, to any of the excipients of the DPI-4452, or to radiographic contrast agents.
  • Any previous CA IX-targeting treatment within 3 months prior to the [68Ga]Ga-DPI-4452 injection.
  • Administration of a radiopharmaceutical within a period corresponding to 10 half-lives of the radionuclide used prior to injection of [68Ga]Ga-DPI-4452.
  • Malignant disease, other than that being treated in this study. Exceptions include the following: malignancies that were treated curatively and have not recurred within 2 years prior to screening; treated basal cell or localized squamous skin carcinomas, localized or low grade (e.g., Gleason 3+3 or 3+4 with low prostate specific antigen) prostate cancer, superficial (non-muscle invasive) urothelial cancer, localized thyroid gland microcarcinoma, other in-situ carcinoma, or other malignancy for which participants are not on active antineoplastic therapy.
  • Ongoing treatment with sulfonamides and/or coumarin derivatives (e.g., acenocoumarol, warfarin, phenprocoumon) within 2 weeks (or 5 half-lives, whichever is longer) prior to the [68Ga]Ga-DPI-4452 injection.
  • Part E:
  • Known hypersensitivity to the active substance, to any of the excipients of the DPI-4452, or to radiographic contrast agents.
  • Administration of a radiopharmaceutical within a period corresponding to 10 half-lives of the radionuclide used prior to injection of [68Ga]Ga-DPI-4452.
  • Any previous CA IX-targeting treatment within 3 months prior to [68Ga]Ga-DPI-4452 injection.
  • EBRT to more than 25% of the bone marrow, as judged by the Investigator.
  • Malignant disease, other than that being treated in this study. Exceptions include the following: malignancies that were treated curatively and have not recurred within 2 years prior to screening; treated basal cell or localized squamous skin carcinomas, localized or low grade (e.g., Gleason 3+3 or 3+4 with low prostate specific antigen) prostate cancer, superficial (non-muscle invasive) urothelial cancer, localized thyroid gland microcarcinoma, other in-situ carcinoma, or other malignancy for which participants are not on active antineoplastic therapy.
  • Note: Other inclusion/exclusion criteria mentioned in the protocol may apply.

Trial locations and contacts

10 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Lumara Bio Oncologics GmbH contact

(+49) 89 329898 66000

info-itm91_94-phase1_2@itm-radiopharma.com

10 sites in 2 countries

France8 sites, 8 recruiting

  • Centre Jean Perrin

    Clermont-Ferrand, 63011

    Recruiting

  • Centre Georges François Leclerc

    Dijon, 21079

    Recruiting

  • CHU de Grenoble-Alpes, Boulevard de la Chantourne

    Grenoble, 38043

    Recruiting

  • Centre Léon Bérard

    Lyon, 69373

    Recruiting

  • AP-HM - Hopital de la Timone

    Marseille, 13005

    Recruiting

  • CHU de Nantes

    Nantes, 44093

    Recruiting

  • IUCT - Oncopole

    Toulouse, 31100

    Recruiting

  • CHRU de Nancy - Hopitaux de Brabois

    Vandœuvre-lès-Nancy, 54511

    Recruiting

Other trials in France

Australia2 sites, 2 recruiting

  • Peter MacCallum Cancer Centre

    Melbourne, VIC 3000

    Recruiting

  • UNSW Sydney, St Vincent's Hospital Sydney

    Sydney, NSW 2010

    Recruiting

Other trials in Australia

About this study

Official title: 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

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.

Being tested
[68Ga]Ga-DPI-4452, [177Lu]Lu-DPI-4452
Medical subject headings
Carcinoma, Renal Cell, Colorectal Neoplasms, Carcinoma, Transitional Cell, Head and Neck Neoplasms, Triple Negative Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [68Ga]Ga-DPI-4452Drug

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

  • [177Lu]Lu-DPI-4452Drug

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

Study groups in NCT05706129
Study groupRoleWhat they receive
Part A: [68Ga]Ga-DPI-4452ExperimentalParticipants will receive [68Ga]Ga-DPI-4452, a single dose on Day 1.
Receives: Drug: [68Ga]Ga-DPI-4452
Part B: [177Lu]Lu-DPI-4452ExperimentalParticipants will receive a single dose of [68Ga]Ga-DPI-4452, at screening then escalating doses of [177Lu]Lu-DPI-4452, on Day 1 of each (Q4W or Q6W) cycle and RP2D will be determined.
Receives: Drug: [68Ga]Ga-DPI-4452; Drug: [177Lu]Lu-DPI-4452
Part C: [177Lu]Lu-DPI-4452ExperimentalParticipants will receive a single dose of [68Ga]Ga-DPI-4452, at screening and RP2D dose of [177Lu]Lu-DPI-4452, on Day 1 of each cycle (Q4W or Q6W) the treatment period.
Receives: Drug: [68Ga]Ga-DPI-4452; Drug: [177Lu]Lu-DPI-4452
Part D: [68Ga]Ga-DPI-4452ExperimentalParticipants will receive [68Ga]Ga-DPI-4452, a single dose on Day 1.
Receives: Drug: [68Ga]Ga-DPI-4452
Part E: [68Ga]Ga-DPI-4452ExperimentalParticipants will receive [68Ga]Ga-DPI-4452, a single dose on Day 1.
Receives: Drug: [68Ga]Ga-DPI-4452

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    Measured: Up to Day 7

  2. Part B: Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)

    Measured: Cycle 1(each cycle = 28 or 42 days depending on every 4 weeks or 6 weeks dosing schedule)

  3. Part C: Objective Response Rate (ORR)

    Measured: Up to 81 months

  4. Part D: Concordance Between [68Ga]Ga-DPI-4452 Uptake by PET Imaging and Assessment of Histological Characteristics of IDRM

    Measured: Day 1

  5. Part E: Radiotracer Uptake at Lesion Level Identified by PET Imaging

    Measured: Day 1

Secondary outcomes (13)

  1. Part A, B, and C: Concentration of [68Ga]Ga-DPI-4452 and [177Lu]Lu-DPI-4452 in Blood and Plasma

    Pharmacokinetics (PK) will be evaluated in blood and plasma for radioactivity of [68Ga]Ga-DPI-4452 and [177Lu]Lu-DPI-4452.

    Measured: Part A: Pre-dose and at multiple time points up to 4 hours post-dose on Day 1; Parts B and C: Pre-dose and at multiple time points up to 72 hours post-dose of Cycles 1, 2 and 3 (84 days) (each cycle = 28 or 42 days depending on every 4 weeks or 6 weeks)

  2. Parts A, B, and C: Concentration of [68Ga]Ga-DPI-4452 and [177Lu]Lu-DPI-4452 in Urine

    PK will be evaluated in urine for radioactivity of [68Ga]Ga-DPI-4452 and [177Lu]Lu-DPI-4452.

    Measured: Part A: Pre-dose and at multiple time points up to 4 hours post-dose on Day 1; Parts B and C: Pre-dose and at multiple time points up to 48 hours post-dose of Cycle 1 (each cycle = 28 or 42 days depending on every 4 weeks or 6 weeks dosing schedule)

  3. Part A: Radioligand [68Ga]Ga-DPI-4452 PET Scan Time-Window for Optimal Imaging

    Measured: Day 1

  4. Part B: Objective Response Rate (ORR)

    Measured: Up to 81 months

  5. Parts B and C: Progression Free Survival (PFS) Rate at 6 Months

    Measured: 6 months

  6. Parts B and C: Progression Free Survival (PFS)

    Measured: Up to 81 months

  7. Parts B and C: Overall Survival (OS)

    Measured: Up to 81 months

  8. Parts B and C: Duration of Response (DoR)

    Measured: Up to 81 months

  9. Parts B and C: Disease Control Rate (DCR)

    Measured: Up to 81 months

  10. Parts B, C, D, and E: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    Measured: Up to 81 months

  11. Parts A, B, C, and E: Number of Positive Tumor Lesions Detected by Imaging

    Measured: Part A and E: Day 1; Part B and C: Baseline

  12. Parts A, B, and C: Dosimetry [68Ga]Ga-DPI-4452 and [177Lu]Lu-DPI-4452

    Whole body effective dose will be calculated using the PET scan.

    Measured: Part A: Day 1; Parts B and C: Cycle 1 (each cycle= 28 days)

  13. Part D: Assessment of Diagnostic Accuracy of [68Ga]Ga-DPI-4452 PET imaging

    Assessment by sensitivity, specificity, positive predicted value (PPV) and negative predicted value (NPV) of [68Ga]Ga-DPI-4452 PET imaging compared to histology.

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2023
  2. Study start14 Mar 2023
  3. Primary completionJun 2027 (estimated)
  4. Study completionMar 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
270 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05706129
Sponsor's protocol ID
ITM-9.4.1.1.01CT
Other IDs
2022-002573-28, 2023-504254-35, U1111-1289-0392, 2023
Status last verified
Aug 2026
First submitted
21 Dec 2022
Last updated
11 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing [68Ga]Ga-DPI-4452 and [177Lu]Lu-DPI-4452 in people with Clear Cell Renal Cell Cancer (ccRCC) and Pancreatic Ductal Adenocarcinoma (PDAC), run by Lumara Bio Oncologics GmbH at 10 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in France, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lumara Bio Oncologics GmbH ((+49) 89 329898 66000, info-itm91_94-phase1_2@itm-radiopharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (time frame: Up to Day 7). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05706129.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.

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