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

Prior treatment

• 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.
• 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.

Other illness

• Presence of active hepatitis.
• 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.

Lab values

• Chronically impaired renal function as expressed by creatinine clearance \< 60 mL/min or serum creatinine \> 1.5 x ULN.

• 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.
• 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.