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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05706129
Registration number
NCT05706129
Ethics application status
Date submitted
21/12/2022
Date registered
31/01/2023
Date last updated
29/03/2024
Titles & IDs
Public 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
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Scientific 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
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Secondary ID [1]
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2022-002573-28
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Secondary ID [2]
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Debio 0228-101
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Clear Cell Renal Cell Cancer (ccRCC)
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Pancreatic Ductal Adenocarcinoma (PDAC)
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Colorectal Cancer (CRC)
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Condition category
Condition code
Cancer
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Kidney
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - [68Ga]Ga-DPI-4452
Treatment: Drugs - [177Lu]Lu-DPI-4452
Experimental: Part A: [68Ga]Ga-DPI-4452 - Participants will receive [68Ga]Ga-DPI-4452, a single dose on Day 1.
Experimental: Part B: [177Lu]Lu-DPI-4452 - 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 28-cycle and RP2D will be determined.
Experimental: Part C: [177Lu]Lu-DPI-4452 - 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 28-day cycle during the treatment period.
Treatment: Drugs: [68Ga]Ga-DPI-4452
[68Ga]Ga-DPI-4452, administered as IV injection.
Treatment: Drugs: [177Lu]Lu-DPI-4452
[177Lu]Lu-DPI-4452, administered as IV infusion.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
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Assessment method [1]
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Timepoint [1]
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Up to Day 7
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Primary outcome [2]
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Part B: Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)
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Assessment method [2]
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Timepoint [2]
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Cycle 1 (28 days)
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Primary outcome [3]
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Part C: Objective Response Rate (ORR)
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Assessment method [3]
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Timepoint [3]
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Up to approximately 2 years
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Secondary outcome [1]
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Part A: Concentration of [68Ga]Ga-DPI-4452 in Blood
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Assessment method [1]
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Pharmacokinetics (PK) will be evaluated in blood for radioactivity of [68Ga]Ga-DPI-4452.
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Timepoint [1]
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Pre-dose and at multiple time points up to 4 hours post-dose on Day 1
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Secondary outcome [2]
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Part A: Radioligand [68Ga]Ga-DPI-4452 Positron Emission Tomography (PET) Scan Time-Window for Optimal Imaging
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Assessment method [2]
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Timepoint [2]
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Day 1
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Secondary outcome [3]
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Part B: Objective Response Rate (ORR)
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Assessment method [3]
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Timepoint [3]
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Up to approximately 2 years
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Secondary outcome [4]
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Parts B and C: Concentration of [177Lu]Lu-DPI-4452 in Blood and Plasma
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Assessment method [4]
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PK will be evaluated in blood and plasma for radioactivity of [177Lu]Lu-DPI-4452.
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Timepoint [4]
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Pre-dose and at multiple time points up to 72 hours post-dose of Cycles 1, 2 and 3 (84 days) {each cycle= 28 days}
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Secondary outcome [5]
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Parts B and C: Progression Free Survival (PFS) Rate at 6 Months
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Assessment method [5]
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Timepoint [5]
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6 months
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Secondary outcome [6]
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Parts B and C: Progression Free Survival (PFS)
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Assessment method [6]
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Timepoint [6]
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Up to approximately 2 years
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Secondary outcome [7]
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Parts B and C: Overall Survival (OS)
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Assessment method [7]
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Timepoint [7]
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Up to approximately 2 years
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Secondary outcome [8]
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Parts B and C: Duration of Response (DoR)
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Assessment method [8]
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Timepoint [8]
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Up to approximately 2 years
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Secondary outcome [9]
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Parts B and C: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
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Assessment method [9]
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Timepoint [9]
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Up to approximately 2 years
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Secondary outcome [10]
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Parts A, B and C: Concentration of [68Ga]Ga-DPI-4452 and [177Lu]Lu-DPI-4452 in Urine
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Assessment method [10]
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PK will be evaluated in urine for radioactivity of [68Ga]Ga-DPI-4452 and [177Lu]Lu-DPI-4452.
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Timepoint [10]
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Part A: Pre-dose and at multiple time points up to 4 hours post-dose on Day 1; Part B: Cycle 1 (each cycle= 28 days); Part C: Pre-dose and at multiple time points up to 24 hours post-dose of Cycle 1 (each cycle= 28 days)
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Secondary outcome [11]
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Parts A, B and C: Number of Positive Tumor Lesions Detected by Imaging
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Assessment method [11]
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Timepoint [11]
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Part A: Day 1; Part B and C: Baseline
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Secondary outcome [12]
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Parts B and C: Disease Control Rate (DCR)
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Assessment method [12]
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Timepoint [12]
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Up to approximately 2 years
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Secondary outcome [13]
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Parts A, B and C: Human Dosimetry [68Ga]Ga-DPI-4452
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Assessment method [13]
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Whole body effective dose will be calculated using the PET scan.
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Timepoint [13]
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Part A: Day 1; Parts B and C: Cycle 1 (each cycle= 28 days)
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Eligibility
Key inclusion criteria
Part A, B and C:
- Written informed consent, dated and signed by the patient prior to any study-specific
procedure
- 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; or
- 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).
- 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Any major surgery within 12 weeks before enrollment
- 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]).
- 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, 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 more than 1 cycle or 1 month.
- 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).
Note: Other inclusion/exclusion criteria mentioned in the protocol may apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1/Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
14/03/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/01/2027
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Actual
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Sample size
Target
155
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Peter MacCallum Cancer Centre - Melbourne
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Recruitment hospital [2]
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UNSW Sydney, St Vincent's Hospital Sydney - Sydney
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Recruitment postcode(s) [1]
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VIC 3000 - Melbourne
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Recruitment postcode(s) [2]
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NSW 2010 - Sydney
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Recruitment outside Australia
Country [1]
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France
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State/province [1]
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Clermont-Ferrand
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Country [2]
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France
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State/province [2]
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Lyon Cedex
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Country [3]
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France
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State/province [3]
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Marseille
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Country [4]
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France
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State/province [4]
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Nantes
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Country [5]
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France
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State/province [5]
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Toulouse
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Country [6]
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France
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State/province [6]
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VandÅ“uvre-lès-Nancy
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Debiopharm International SA
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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; 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; Part C: is to evaluate the preliminary antitumor
activity of [177Lu]Lu-DPI-4452 as monotherapy.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05706129
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Debiopharm International S.A
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Address
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Country
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Phone
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+41 21 321 01 11
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05706129
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