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

NCT06840548 | Completed Phase 1

• 2 other identifiers: PH-CAIXGA-02/242024-515607-19-00
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Clear Cell Renal Cell Carcinoma (ccRCC)

Keywords

clear cell renal cell carcinoma

Outcome Measures

Primary Outcomes (3)

• Cohort A: Dosimetry - Effective dose equivalent (mSv)

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

  Assessed on day 1

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

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

  Assessed on day 1

• 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).

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

Secondary Outcomes (5)

• Biodistribution profile: SUVmax

  Assessed on day 1

• Biodistribution profile: SUVmean

  Assessed on day 1

• Biodistribution profile: SUVsd

  Assessed on day 1

• Pharmacokinetics (PK) - Blood

  Assessed on day 1

• Excretion - Urine

  Assessed on day 1

Study Arms (2)

Coort A

EXPERIMENTAL

3 female + 3 male patients without visceral or bone metastases, which would interfere with dosimetry evaluation of healthy organs.

Drug: [68Ga]Ga-OncoCAIX

Cohort B

EXPERIMENTAL

all patients who meet the eligibility criteria (up to 14 patients)

Drug: [68Ga]Ga-OncoCAIX

Interventions

[68Ga]Ga-OncoCAIX DRUG

Single intravenous bolus administration.

Cohort B; Coort A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• Philogen S.p.A.: lead

Study Sites (3)

ASST Papa Giovanni XXIII

Bergamo, BG, 24127, Italy

Location

IRCCS Ospedale San Raffaele

Milan, Milano, 20132, Italy

Location

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Milano, 20133, Italy

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: February 21, 2025
• Study Start: April 16, 2025
• Primary Completion: November 28, 2025
• Study Completion: November 28, 2025
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3)