AzTrials
AzTrials

Clear Cell Renal Cell Carcinoma (ccRCC)Phase 1OncoCAIXNCT06840548

A Study to Evaluate the Safety and Dosimetry of 68Ga-OncoCAIX in Patients With CAIX-positive Cancer

A Phase 1 study testing [68Ga]Ga-OncoCAIX in people with Clear Cell Renal Cell Carcinoma (ccRCC), run by Philogen S.p.A. at 3 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Phase I and multicenter study to evaluate the safety and dosimetry of 68Ga-OncoCAIX in patients with clear cell renal cell carcinoma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Clear Cell Renal Cell Carcinoma (ccRCC)
What is being tested?
[68Ga]Ga-OncoCAIX
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
3 sitesItaly
Study dates
16 Apr 2025to 28 Nov 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with suspected ccRCC (based on standard diagnostic workup).
  • Requirement for diagnostic imaging or diagnostic imaging recently performed.
  • For female patients: negative serum pregnancy test for women of childbearing potential* (WOCBP). WOCBP must agree to use, from the screening to six months following the study drug administration, highly effective contraception methods, as defined by the "Recommendations for contraception and pregnancy testing in clinical trials" issued by the Head of Medicine Agencies' Clinical Trial Facilitation Group (www.hma.eu/ctfg.html) and which include, for instance, progesterone only or combined hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone-releasing systems, bilateral tubal occlusion or vasectomized partner.
  • For male patients: Subjects able to father children must agree to practice effective contraception for three months starting from the study drug administration.
  • Age ≥ 18
  • ECOG ≤ 1
Show all 12Show fewer
  • Patient must not have any concomitant infections or active concomitant disease.
  • All acute toxic effects (excluding alopecia and fatigue) of any prior therapy (including surgery, radiation therapy, chemotherapy) must have resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (v. 5.0) Grade ≤ 1.
  • Life expectancy of more than 12 weeks.
  • Ability to undergo imaging study procedures.
  • Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
  • Willingness and ability to comply with the scheduled visits, plan, laboratory tests and other study procedures.

Who cannot join

  • Chronically impaired renal function as expressed by creatinine clearance < 60 mL/min or serum creatinine > 1.5 x ULN.
  • Presence of active hepatitis.
  • Presence of significant cardiac disorders (congestive heart failure, NYHA class III-IV, myocardial infarction within one year prior to study entry, uncontrolled hypertension, or arrhythmia).
  • Any concomitant condition which in the opinion of investigators makes it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol.
  • Major trauma including major surgery (such as abdominal/cardiac/thoracic surgery) within 4 weeks of administration of the study drug. Minimally invasive procedures such as biopsies are not considered as exclusion criteria.
  • Serious, non-healing wound, ulcer, or bone fracture.
Show all 9Show fewer
  • Allergy to study medication or excipients in study medication.
  • Any anti-cancer therapy (e.g. cytotoxic chemotherapy, immunotherapy, radiation, surgery, etc.) within 3 weeks before [68Ga]Ga-OncoCAIX-PET/CT scan.
  • Subject has received, or is scheduled to receive, another investigational medicinal product (IMP) from one month before [68Ga]Ga-OncoCAIX injection to end of study participation.

Trial locations and contacts

3 sites in 1 country.

Italy3 sites

  • ASST Papa Giovanni XXIII

    Bergamo, BG, 24127

  • IRCCS Ospedale San Raffaele

    Milan, Milano, 20132

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, Milano, 20133

Other trials in Italy

About this study

Official title: A Phase I Study to Evaluate the Safety and Dosimetry of 68Ga-OncoCAIX in Patients With CAIX-positive Cancer

Phase I and multicenter study to evaluate the safety and dosimetry of 68Ga-OncoCAIX in patients with clear cell renal cell carcinoma.

Read the detailed description

The Carbonic Anhydrase IX (CAIX) is a clinically validated marker of clear-cell renal cell carcinoma (ccRCC) and hypoxic tumors. OncoCAIX is a new ligand for CAIX.

This is a Phase I, multicenter study in patients with suspected ccRCC to evaluate the safety, dosimetry and biodistribution of 68Ga-OncoCAIX for imaging of ccRCC. In this trial, 68Ga-OncoCAIX is offered to ccRCC patients who already received standard of care imaging and might therefore complement available modalities.

All patients will undergo PET/CT imaging with [68Ga]Ga-OncoCAIX. The principal objective of the study is to evaluate safety and dosimetry of a single administration of [68Ga]Ga-OncoCAIX. In addition, data on the uptake, biodistribution, PK and excretion of [68Ga]Ga-OncoCAIX is collected and technical parameters are evaluated.

Patients are divided into two cohorts:

  • Cohort A: 3 female + 3 male patients without visceral or bone metastases, which would interfere with dosimetry evaluation of healthy organs.
  • Cohort B: all patients who meet the eligibility criteria (up to 14 patients)

Both cohorts are recruited in parallel, and patients are assigned to the respective cohort based on their disease extent. Whenever possible, patients are enrolled in cohort A, unless they are unsuitable for cohort A, or the required number of patients of a given sex has already been enrolled in cohort A.

All patients will receive a single intravenous bolus administration of [68Ga]Ga-OncoCAIX and biodistribution, PK, and dosimetry of [68Ga]Ga-OncoCAIX will be assessed based on a series of PET/CT scans, blood and urine sampling.

Full dosimetry evaluations will be performed for all patients in cohort A. Additional dosimetry in the other patients may be performed to the extent that it is possible based on their disease burden (i.e., only organs not affected by malignant lesions can be evaluated).

All patients will be assessed for safety. In addition, relative uptake to appropriate reference tissue of [68Ga]Ga-OncoCAIX as well as semiquantitative parameters such as SUVmax/SUVmean/SUVsd, are determined. The correlation of [68Ga]Ga-OncoCAIX uptake with immunopathology staining for CAIX will be evaluated in patients undergoing surgery or tumor biopsy collection. The lesion detection rate will be compared to 18F-FDG-PET/CT in patients who receive this as part of their standard diagnostic workup.

Being tested
[68Ga]Ga-OncoCAIX
Keywords
clear cell renal cell carcinoma
Medical subject headings
Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [68Ga]Ga-OncoCAIXDrug

    Single intravenous bolus administration.

Study groups in NCT06840548
Study groupRoleWhat they receive
Coort AExperimental3 female + 3 male patients without visceral or bone metastases, which would interfere with dosimetry evaluation of healthy organs.
Receives: Drug: [68Ga]Ga-OncoCAIX
Cohort BExperimentalall patients who meet the eligibility criteria (up to 14 patients)
Receives: Drug: [68Ga]Ga-OncoCAIX

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cohort A: Dosimetry - Effective dose equivalent (mSv)

    Whole-body effective dose (mSv) following administration of a single dose of [68Ga]Ga-OncoCAIX.

    Measured: Assessed on day 1

  2. Cohort A: Dosimetry - Effective dose absorbed doses (mGy)

    Absorbed doses (mGy) of normal organs following administration of a single dose of [68Ga]Ga-OncoCAIX.

    Measured: Assessed on day 1

  3. All patients: Safety (AEs and SAEs)

    Safety of administration of [68Ga]Ga-OncoCAIX, according to Common Terminology Criteria for Adverse Events (CTCAE v.5.0).

    Measured: Throughout the study, until a maximum of 7 days after the administration of the study drug.

Secondary outcomes (5)

  1. Biodistribution profile: SUVmax

    Uptake of [ 68Ga]Ga-OncoCAIX in tumor lesions and healthy organs in terms of SUVmax

    Measured: Assessed on day 1

  2. Biodistribution profile: SUVmean

    Uptake of [68Ga]Ga-OncoCAIX in tumor lesions and healthy organs in terms of SUVmean

    Measured: Assessed on day 1

  3. Biodistribution profile: SUVsd

    Uptake of [68Ga]Ga-OncoCAIX in tumor lesions and healthy organs in terms of SUVsd

    Measured: Assessed on day 1

  4. Pharmacokinetics (PK) - Blood

    Pharmacokinetics (PK) of [68Ga]Ga-OncoCAIX based on measurement on blood of residual radioactivity over time [kBq/mL].

    Measured: Assessed on day 1

  5. Excretion - Urine

    Excretion of [68Ga]Ga-OncoCAIX based on measurement of residual radioactivity in the urine over time [kBq]

    Measured: Assessed on day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2025
  2. Study start16 Apr 2025
  3. Primary completion28 Nov 2025
  4. Study completion28 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Patients are divided into two cohorts: * Cohort A: 3 female + 3 male patients without visceral or bone metastases, which would interfere with dosimetry evaluation of healthy organs. * Cohort B: all patients who meet the eligibility criteria (up to 14 patients)
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06840548
Sponsor's protocol ID
PH-CAIXGA-02/24
Other IDs
2024-515607-19-00
Acronym
OncoCAIX
Status last verified
Jan 2026
First submitted
17 Feb 2025
Last updated
13 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [68Ga]Ga-OncoCAIX in people with Clear Cell Renal Cell Carcinoma (ccRCC), run by Philogen S.p.A. at 3 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cohort A: Dosimetry - Effective dose equivalent (mSv) (time frame: Assessed on day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06840548.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in