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
- Conditions
- Clear Cell Renal Cell Cancer (ccRCC)Pancreatic Ductal Adenocarcinoma (PDAC)Colorectal Cancer (CRC)
- Registration Number
- NCT05706129
- Lead Sponsor
- Debiopharm International SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 170
Inclusion Criteria:<br><br>Part A, B and C:<br><br> - Written informed consent, dated and signed by the patient prior to any<br> study-specific procedure<br><br> - Has histologically or cytologically confirmed, unresectable locally advanced or<br> metastatic solid tumors of:<br><br> - clear cell renal cell cancer (ccRCC) - participants must have received at least one<br> line containing Tyrosine kinase inhibitor (TKI) treatment and at least one line<br> containing Immune Checkpoint Inhibitor treatment in metastatic setting, meaning at<br> least two lines of treatment in metastatic setting,<br><br> - pancreatic ductal adenocarcinoma (PDAC) - participants must have received at least<br> one line of platinum- and/or gemcitabine based regimen; or<br><br> - colorectal cancer (CRC) - participants must have received at least one line of<br> FOLFIRINOX or FOLFOX/FOLFIRI in two lines in combination with anti-Vascular<br> Endothelial Growth Factor (VEGF) or anti-Epidermal Growth Factor Receptor (EGFR).<br><br> - Participants with CRC or PDAC: availability of fresh biopsy, OR an archival<br> biopsy/surgical specimen of the tumor (preferably, taken after last prior line of<br> therapy).<br><br> - Presence of at least 1 non-irradiated tumor lesion detected at conventional imaging<br> (computed tomography / magnetic resonance imaging (CT/MRI)) documented within 4<br> weeks prior to the [68Ga]Ga-DPI-4452 administration.<br><br> - Measurable disease per response evaluation criteria in solid tumors (RECIST) v1.1<br><br>Exclusion Criteria:<br><br> - Any major surgery within 12 weeks before enrollment<br><br> - Inability to stay in the scanner bed with the arms resting out of the thoracic and<br> abdominal fields (i.e., arms alongside the body or raised arm position) for the<br> duration of the scan<br><br>Part A:<br><br> - Has known hypersensitivity to the active substance, to any of the excipients of the<br> DPI-4452, or to radiographic contrast agents.<br><br> - Bladder outflow obstruction or unmanageable urinary incontinence.<br><br> - Participants who have not had resolution of clinically significant toxic effects of<br> prior systemic cancer therapy, surgery, or radiotherapy to Grade =1 (except for<br> laboratory parameters specified above, Grade 2 alopecia, and/or stable Grade 2<br> sensory neuropathy, according to National Cancer Institute Common Terminology<br> Criteria for Adverse Events [NCI-CTCAE]).<br><br> - Administration of a radiopharmaceutical within a period corresponding to 10<br> half-lives of the radionuclide used prior to injection of [68Ga]Ga-DPI-4452.<br><br> - Previous Carbonic anhydrase (CA) IX-targeting treatment.<br><br> - Prior external beam radiation therapy (EBRT) to more than 25% of the bone marrow, as<br> judged by the Investigator.<br><br>Part B and Part C:<br><br> - Known hypersensitivity to the active substance, to any of the excipients of the<br> DPI-4452, or to radiographic contrast agents.<br><br> - Bladder outflow obstruction or unmanageable urinary incontinence.<br><br> - Participants who have not had resolution of clinically significant toxic effects of<br> prior systemic cancer therapy, surgery, or radiotherapy to Grade =1 (except for<br> laboratory parameters specified above, Grade 2 alopecia, or stable Grade 2 sensory<br> neuropathy, according to NCI-CTCAE).<br><br> - Administration of a radiopharmaceutical with therapeutic intent within a period of 6<br> months prior to injection of [68Ga]Ga-DPI-4452.<br><br> - Any previous CA IX-targeting treatment for more than 1 cycle or 1 month.<br><br> - Participants who received any systemic antineoplastic therapy for the underlying<br> disease and/or other investigational agents within a period which is =5 half-lives<br> or =4 weeks (whichever is shorter).<br><br> - Inflammatory bowel disease (e.g Crohn's disease, ulcerative colitis, etc).<br><br>Note: Other inclusion/exclusion criteria mentioned in the protocol may apply.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Part A: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs);Part B: Number of Participants Experiencing Dose-Limiting Toxicities (DLTs);Part C: Objective Response Rate (ORR)
- Secondary Outcome Measures
Name Time Method Part A: Concentration of [68Ga]Ga-DPI-4452 in Blood;Part A: Radioligand [68Ga]Ga-DPI-4452 Positron Emission Tomography (PET) Scan Time-Window for Optimal Imaging;Part B: Objective Response Rate (ORR);Parts B and C: Concentration of [177Lu]Lu-DPI-4452 in Blood and Plasma;Parts B and C: Progression Free Survival (PFS) Rate at 6 Months;Parts B and C: Progression Free Survival (PFS);Parts B and C: Overall Survival (OS);Parts B and C: Duration of Response (DoR);Parts B and C: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs);Parts A, B and C: Concentration of [68Ga]Ga-DPI-4452 and [177Lu]Lu-DPI-4452 in Urine;Parts A, B and C: Number of Positive Tumor Lesions Detected by Imaging;Parts B and C: Disease Control Rate (DCR);Parts A, B and C: Human Dosimetry [68Ga]Ga-DPI-4452