Clinical trial • Phase III • Oncology

ZIRCONIUM (89ZR) GIRENTUXIMAB for Clear cell renal cell carcinoma | Metastatic renal cell carcinoma

Phase III trial of ZIRCONIUM (89ZR) GIRENTUXIMAB for Clear cell renal cell carcinoma | Metastatic renal cell carcinoma.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Clear cell renal cell carcinoma | Metastatic renal cell carcinoma
Trial Stage
Phase III
Drug Modality
Radiopharmaceutical | Monoclonal antibody | Peptide/protein/enzyme

Key dates

Initial CTIS Submission Date
23-10-2024
First CTIS Authorization Date
25-02-2025

Trial design

68Ga-gozetotide (PSMA) PET-CT (investigational product: Gallium (68Ga) PSMA-11 (gozetotide) prepared using PSMA-11 Sterile Cold Kit; max dose listed 259 MBq, intravenous) versus 89Zr-DFO-girentuximab PET-CT (investigational product: Zr-DFO-girentuximab; max dose listed 37 MBq, intravenous), both in addition to conventional contrast enhanced CT.-controlled Phase III trial across 1 site in Netherlands.

Comparator
68Ga-gozetotide (PSMA) PET-CT (investigational product: Gallium (68Ga) PSMA-11 (gozetotide) prepared using PSMA-11 Sterile Cold Kit; max dose listed 259 MBq, intravenous) versus 89Zr-DFO-girentuximab PET-CT (investigational product: Zr-DFO-girentuximab; max dose listed 37 MBq, intravenous), both in addition to conventional contrast enhanced CT.
Target Sample Size
20

Eligibility

Recruits 20 Vulnerable population not included; participants are adults (≥ 18 years). isVulnerablePopulationSelected=false. Informed consent materials available (Subject information and informed consent form L1_SIS and ICF). No assent procedure described..

Pregnancy Exclusion
Possibility of pregnancy (anamnestic, if ambiguity; a pregnancy test will be conducted prior to the PET/CT) or lactation.
Vulnerable Population
Vulnerable population not included; participants are adults (≥ 18 years). isVulnerablePopulationSelected=false. Informed consent materials available (Subject information and informed consent form L1_SIS and ICF). No assent procedure described.

Inclusion criteria

  • {"criterion_text":"- ≥ 18 years"}
  • {"criterion_text":"- Suspicion of metastatic ccRCC on conventional contrast-enhanced CT (performed max. 4 weeks prior to the PET scan). Diagnosis may or may not be proven by biopsy prior to inclusion in the study. Primary tumor may or may not be in place."}

Exclusion criteria

  • {"criterion_text":"- History of a CAIX-negative, PSMA negative or non-clear cell RCC."}
  • {"criterion_text":"- Administration of tyrosine kinase inhibitors within 1 month prior to inclusion."}
  • {"criterion_text":"- Renal insufficiency with GFR ≤ 45 mL/min/1.73m2"}
  • {"criterion_text":"- Second active malignancy (except basal-cell carcinoma)."}
  • {"criterion_text":"- Administration of a radioisotope within 10 physical half-lives prior to study enrollment."}
  • {"criterion_text":"- Possibility of pregnancy (anamnestic, if ambiguity; a pregnancy test will be conducted prior to the PET/CT) or lactation."}
  • {"criterion_text":"- Known hypersensitivity or formation of human anti-chimeric antibodies (HACA) against girentuximab or DFO."}
  • {"criterion_text":"- No verbal and written command of Dutch language"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- To evaluate the tumor detectability/detection rate (descriptive) of 68Ga-gozetotide (PSMA) PET-CT compared to 89Zr-DFO-girentuximab PET-CT (both in addition to conventional contrast enhanced CT) in patients with the suspicion of metastatic ccRCC. The denominator will consist of the conventional diagnostic contrast enhanced CT, 68Ga-gozetotide (PSMA) PET-CT and 89Zr-DFO-girentuximab PET-CT.","definition_or_measurement_approach":"Tumor detectability/detection rate (descriptive) comparing 68Ga-gozetotide PET-CT and 89Zr-DFO-girentuximab PET-CT, with the denominator consisting of conventional contrast enhanced CT, 68Ga-gozetotide PET-CT and 89Zr-DFO-girentuximab PET-CT."}

Secondary endpoints

  • {"endpoint_text":"- The semi-quantitative assessment of the SUVmax in primary tumor (if in situ) and SUVmax of metastases (lesion based analyses).","definition_or_measurement_approach":"Semi-quantitative lesion-based analyses measuring SUVmax in primary tumor (if in situ) and in metastases."}
  • {"endpoint_text":"- Tumor-to-background ratio of primary tumor (if in situ) and tumor-to-background ratio of metastases.","definition_or_measurement_approach":"Calculation of tumor-to-background ratios for primary tumor (if in situ) and for metastases."}

Recruitment

Planned Sample Size
20
Recruitment Window Months
24
Consent Approach
Informed consent obtained from each participant using the Subject information and informed consent form (document L1_SIS and ICF). Participants are adults (≥18) and provide consent themselves. No assent procedures described. Languages available for consent not specified.

Geography

Total Number Of Sites
1
Total Number Of Participants
20

Netherlands

Earliest CTIS Part Ii Submission Date
23-01-2025
Latest Decision Or Authorization Date
25-02-2025
Processing Time Days
33
Number Of Sites
1
Number Of Participants
20

Sites

Site Name
Stichting Radboud universitair medisch centrum
Department Name
Urology
Principal Investigator Name
Peter F.A. Mulders
Principal Investigator Email
secretariaat.uro@radboudumc.nl
Contact Person Name
Peter F.A. Mulders
Contact Person Email
secretariaat.uro@radboudumc.nl
Number Of Participants
20

Sponsor

Primary sponsor

Full Name
Stichting Radboud universitair medisch centrum
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Netherlands

Investigational products

Investigational Product Name
Zr-DFO-girentuximab
Active Substance
ZIRCONIUM (89ZR) GIRENTUXIMAB
Modality
Radiopharmaceutical | Monoclonal antibody
Routes Of Administration
Intravenous administration
Route
Intravenous administration
Authorisation Status
Authorised
Frequency
Single administration (maxTreatmentPeriod=1)
Maximum Dose
37 MBq
Investigational Product Name
Gallium (68Ga) PSMA-11 (gozetotide) prepared using PSMA-11 Sterile Cold Kit
Active Substance
GALLIUM (68GA) GOZETOTIDE
Modality
Radiopharmaceutical | Peptide/protein/enzyme
Routes Of Administration
Intravenous administration
Route
Intravenous administration
Authorisation Status
Authorised
Frequency
Single administration (maxTreatmentPeriod=1)
Maximum Dose
259 MBq

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