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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-002573-28 | EudraCT Number | ||
| 2023-504254-35 | Other Identifier | EU CT Number | |
| U1111-1289-0392 | Other Identifier | WHO Unique Trial Identifier |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: [68Ga]Ga-DPI-4452 | Experimental | Participants will receive [68Ga]Ga-DPI-4452, a single dose on Day 1. |
|
| Part B: [177Lu]Lu-DPI-4452 | Experimental | Participants 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. |
|
| Part C: [177Lu]Lu-DPI-4452 | Experimental | Participants 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. |
|
| Part D: [68Ga]Ga-DPI-4452 | Experimental | Participants will receive [68Ga]Ga-DPI-4452, a single dose on Day 1. |
|
| Part E: [68Ga]Ga-DPI-4452 | Experimental | Participants will receive [68Ga]Ga-DPI-4452, a single dose on Day 1. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [68Ga]Ga-DPI-4452 | Drug | [68Ga]Ga-DPI-4452, administered as IV injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Up to Day 7 | |
| Part B: Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) | Cycle 1(each cycle = 28 or 42 days depending on every 4 weeks or 6 weeks dosing schedule) | |
| Part C: Objective Response Rate (ORR) | Up to 81 months | |
| Part D: Concordance Between [68Ga]Ga-DPI-4452 Uptake by PET Imaging and Assessment of Histological Characteristics of IDRM | Day 1 | |
| Part E: Radiotracer Uptake at Lesion Level Identified by PET Imaging | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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) |
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Inclusion Criteria:
Part A, B, and C:
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
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)
Exclusion Criteria:
Part A:
Part B and Part C:
Part D:
Part E:
Note: Other inclusion/exclusion criteria mentioned in the protocol may apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ITM Oncologics GmbH | Contact | (+49) 89 329898 66000 | info-itm91_94-phase1_2@itm-radiopharma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peter MacCallum Cancer Centre | Recruiting | Melbourne | VIC 3000 | Australia | ||
| UNSW Sydney, St Vincent's Hospital Sydney |
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| [177Lu]Lu-DPI-4452 | Drug | [177Lu]Lu-DPI-4452, administered as IV infusion. |
|
| 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. | 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) |
| Part A: Radioligand [68Ga]Ga-DPI-4452 PET Scan Time-Window for Optimal Imaging | Day 1 |
| Part B: Objective Response Rate (ORR) | Up to 81 months |
| Parts B and C: Progression Free Survival (PFS) Rate at 6 Months | 6 months |
| Parts B and C: Progression Free Survival (PFS) | Up to 81 months |
| Parts B and C: Overall Survival (OS) | Up to 81 months |
| Parts B and C: Duration of Response (DoR) | Up to 81 months |
| Parts B and C: Disease Control Rate (DCR) | Up to 81 months |
| Parts B, C, D, and E: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Up to 81 months |
| Parts A, B, C, and E: Number of Positive Tumor Lesions Detected by Imaging | Part A and E: Day 1; Part B and C: Baseline |
| 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. | Part A: Day 1; Parts B and C: Cycle 1 (each cycle= 28 days) |
| 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. | Day 1 |
| Recruiting |
| Sydney |
| NSW 2010 |
| Australia |
| Centre Jean Perrin | Recruiting | Clermont-Ferrand | 63011 | France |
| Centre Georges François Leclerc | Recruiting | Dijon | 21079 | France |
| CHU de Grenoble-Alpes, Boulevard de la Chantourne | Recruiting | Grenoble | 38043 | France |
| Centre Léon Bérard | Recruiting | Lyon | 69373 | France |
| AP-HM - Hopital de la Timone | Recruiting | Marseille | 13005 | France |
| CHU de Nantes | Recruiting | Nantes | 44093 | France |
| IUCT - Oncopole | Recruiting | Toulouse | 31100 | France |
| CHRU de Nancy - Hopitaux de Brabois | Recruiting | Vandœuvre-lès-Nancy | 54511 | France |
| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| D015179 | Colorectal Neoplasms |
| D002295 | Carcinoma, Transitional Cell |
| D006258 | Head and Neck Neoplasms |
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D001943 | Breast Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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