CompletedPhase 1

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

Italy20 participantsStarted 2025-04-16

Plain-language summary

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

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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
✓. 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.

✕. 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.
✕. 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.

Cohort A: Dosimetry - Effective dose equivalent (mSv)

Timeframe: Assessed on day 1

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

Timeframe: Assessed on day 1

All patients: Safety (AEs and SAEs)

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

NCT IDNCT06840548

SponsorPhilogen S.p.A.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-11-28

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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
✓. 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.

✕. 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.
✕. 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.

What they're measuring

Cohort A: Dosimetry - Effective dose equivalent (mSv)

Timeframe: Assessed on day 1

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

Timeframe: Assessed on day 1

All patients: Safety (AEs and SAEs)

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