The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    Debio 0228-101
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05706129
Recruitment Status : Recruiting
First Posted : January 31, 2023
Last Update Posted : March 29, 2024
Sponsor:
Information provided by (Responsible Party):
Debiopharm International SA

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Clear Cell Renal Cell Cancer (ccRCC) Pancreatic Ductal Adenocarcinoma (PDAC) Colorectal Cancer (CRC) Drug: [68Ga]Ga-DPI-4452 Drug: [177Lu]Lu-DPI-4452 Phase 1 Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 155 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 14, 2023
Estimated Primary Completion Date : January 2026
Estimated Study Completion Date : January 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Part A: [68Ga]Ga-DPI-4452
Participants will receive [68Ga]Ga-DPI-4452, a single dose on Day 1.
 Drug: [68Ga]Ga-DPI-4452
[68Ga]Ga-DPI-4452, administered as IV injection.
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.
 Drug: [68Ga]Ga-DPI-4452
[68Ga]Ga-DPI-4452, administered as IV injection.

Drug: [177Lu]Lu-DPI-4452
[177Lu]Lu-DPI-4452, administered as IV infusion.
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.
 Drug: [68Ga]Ga-DPI-4452
[68Ga]Ga-DPI-4452, administered as IV injection.

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to Day 7 ]
  2. Part B: Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) [ Time Frame: Cycle 1 (28 days) ]
  3. Part C: Objective Response Rate (ORR) [ Time Frame: Up to approximately 2 years ]

Secondary Outcome Measures :
  1. Part A: Concentration of [68Ga]Ga-DPI-4452 in Blood [ Time Frame: Pre-dose and at multiple time points up to 4 hours post-dose on Day 1 ]
    Pharmacokinetics (PK) will be evaluated in blood for radioactivity of [68Ga]Ga-DPI-4452.

  2. Part A: Radioligand [68Ga]Ga-DPI-4452 Positron Emission Tomography (PET) Scan Time-Window for Optimal Imaging [ Time Frame: Day 1 ]
  3. Part B: Objective Response Rate (ORR) [ Time Frame: Up to approximately 2 years ]
  4. Parts B and C: Concentration of [177Lu]Lu-DPI-4452 in Blood and Plasma [ Time Frame: 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} ]
    PK will be evaluated in blood and plasma for radioactivity of [177Lu]Lu-DPI-4452.

  5. Parts B and C: Progression Free Survival (PFS) Rate at 6 Months [ Time Frame: 6 months ]
  6. Parts B and C: Progression Free Survival (PFS) [ Time Frame: Up to approximately 2 years ]
  7. Parts B and C: Overall Survival (OS) [ Time Frame: Up to approximately 2 years ]
  8. Parts B and C: Duration of Response (DoR) [ Time Frame: Up to approximately 2 years ]
  9. Parts B and C: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to approximately 2 years ]
  10. Parts A, B and C: Concentration of [68Ga]Ga-DPI-4452 and [177Lu]Lu-DPI-4452 in Urine [ Time Frame: 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) ]
    PK will be evaluated in urine for radioactivity of [68Ga]Ga-DPI-4452 and [177Lu]Lu-DPI-4452.

  11. Parts A, B and C: Number of Positive Tumor Lesions Detected by Imaging [ Time Frame: Part A: Day 1; Part B and C: Baseline ]
  12. Parts B and C: Disease Control Rate (DCR) [ Time Frame: Up to approximately 2 years ]
  13. Parts A, B and C: Human Dosimetry [68Ga]Ga-DPI-4452 [ Time Frame: Part A: Day 1; Parts B and C: Cycle 1 (each cycle= 28 days) ]
    Whole body effective dose will be calculated using the PET scan.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05706129


Contacts
Layout table for location contacts
Contact: Debiopharm International S.A +41 21 321 01 11 clinicaltrials@debiopharm.com

Locations
Layout table for location information
Australia
Peter MacCallum Cancer Centre Recruiting
Melbourne, Australia, VIC 3000
UNSW Sydney, St Vincent's Hospital Sydney Recruiting
Sydney, Australia, NSW 2010
France
Centre Jean Perrin Recruiting
Clermont-Ferrand, France, 63011
Centre Léon Bérard Not yet recruiting
Lyon Cedex, France, 69373
AP-HM - Hopital de la Timone Not yet recruiting
Marseille, France, 13005
CHU de Nantes Recruiting
Nantes, France, 44093
IUCT - Oncopole Not yet recruiting
Toulouse, France, 31100
CHRU de Nancy - Hopitaux de Brabois Recruiting
Vandœuvre-lès-Nancy, France, 54511
Sponsors and Collaborators
Debiopharm International SA
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Debiopharm International SA
ClinicalTrials.gov Identifier: NCT05706129    
Other Study ID Numbers: Debio 0228-101
2022-002573-28 ( EudraCT Number )
2023-504254-35 ( Other Identifier: EU CT Number )
U1111-1289-0392 ( Other Identifier: WHO Unique Trial Identifier )
First Posted: January 31, 2023    Key Record Dates
Last Update Posted: March 29, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma, Renal Cell
Neoplasms by Site
Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
 Urologic Neoplasms
Urogenital Neoplasms
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Kidney Diseases
Urologic Diseases
Male Urogenital Diseases