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Recruitment on holdLast updated: 19 January 2024

This study is assessing how safe, tolerable and effective a combination of radiopeptides that target CAIX in people with advanced or metastatic clear cell renal cell cancer, pancreatic ductal cancer, or colorectal cancerA 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

Clinical summary

Summary

This study has three parts.

Part A aims to evaluate the safety, tolerability and tracer uptake after a single intravenous (IV) injection administration of [68Ga]Ga-DPI-4452. In this part, participants will receive [68Ga]Ga-DPI-4452 as a single dose on Day 1. Note: Part A is complete at PCCTU and no longer recruiting.

Part B aims to determine the recommended Phase 2 dose (RP2D) for [177Lu]Lu-DPI-4452 for each tumour type. In this part, participants will receive a single dose of [68Ga]Ga-DPI-4452 as an IV injection at screening, and then escalating doses of [177Lu]Lu-DPI-4452 on Day 1 of each 28-day cycle and RP2D will be determined. [177Lu]Lu-DPI-4452 will be administered as an IV infusion.

Part C aims to evaluate the preliminary antitumour activity of [177Lu]Lu-DPI-4452 as monotherapy. In this part, participants will receive a single dose of [68Ga]Ga-DPI-4452, at screening, and the RP2D dose (as determined in Part B) of [177Lu]Lu-DPI-4452 on Day 1 of each 28-day cycle during the treatment period. 

Conditions

This trial is treating patients with clear cell renal cell cancer (ccRCC), pancreatic ductal adenocarcinoma (PRAC) or colorectal cancer (CRC) who have had prior treatment

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I/II

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

  • NCT05706129
  • DEBIO 0228-101; 2022-002573-28; 2023-504254-35; U1111-1289-0392

Trial sponsor

Debiopharm International SA

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

Eligibility

Inclusion

  • 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

  • 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.

Inclusion

  • You have had a certain type of treatment or surgical procedure.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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