Trial 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
NCT ID:
NCT05706129
Condition:
Clear Cell Renal Cell Cancer (ccRCC)
Pancreatic Ductal Adenocarcinoma (PDAC)
Colorectal Cancer (CRC)
Conditions: Official terms:
Carcinoma, Renal Cell
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
[68Ga]Ga-DPI-4452
Description:
[68Ga]Ga-DPI-4452, administered as IV injection.
Arm group label:
Part A: [68Ga]Ga-DPI-4452
Arm group label:
Part B: [177Lu]Lu-DPI-4452
Arm group label:
Part C: [177Lu]Lu-DPI-4452
Intervention type:
Drug
Intervention name:
[177Lu]Lu-DPI-4452
Description:
[177Lu]Lu-DPI-4452, administered as IV infusion.
Arm group label:
Part B: [177Lu]Lu-DPI-4452
Arm group label:
Part C: [177Lu]Lu-DPI-4452
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; 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.
Criteria for eligibility:
Criteria:
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
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Peter MacCallum Cancer Centre
Address:
City:
Melbourne
Zip:
VIC 3000
Country:
Australia
Status:
Recruiting
Facility:
Name:
UNSW Sydney, St Vincent's Hospital Sydney
Address:
City:
Sydney
Zip:
NSW 2010
Country:
Australia
Status:
Recruiting
Facility:
Name:
Centre Jean Perrin
Address:
City:
Clermont-Ferrand
Zip:
63011
Country:
France
Status:
Recruiting
Facility:
Name:
CHU de Grenoble-Alpes, Boulevard de la Chantourne
Address:
City:
Grenoble
Zip:
38043
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Centre Léon Bérard
Address:
City:
Lyon Cedex
Zip:
69373
Country:
France
Status:
Not yet recruiting
Facility:
Name:
AP-HM - Hopital de la Timone
Address:
City:
Marseille
Zip:
13005
Country:
France
Status:
Not yet recruiting
Facility:
Name:
CHU de Nantes
Address:
City:
Nantes
Zip:
44093
Country:
France
Status:
Recruiting
Facility:
Name:
IUCT - Oncopole
Address:
City:
Toulouse
Zip:
31100
Country:
France
Status:
Not yet recruiting
Facility:
Name:
CHRU de Nancy - Hopitaux de Brabois
Address:
City:
Vandœuvre-lès-Nancy
Zip:
54511
Country:
France
Status:
Recruiting
Start date:
March 14, 2023
Completion date:
March 2029
Lead sponsor:
Agency:
Debiopharm International SA
Agency class:
Industry
Source:
Debiopharm International SA
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05706129
