Safety and Preliminary Diagnostic Performance of [⁶⁴Cu]Cu-RAX301 in Prostate Cancer

Sponsor
RadAlliance Therapeutics, Inc
Study ID
NCT07765940
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • [⁶⁴Cu]Cu-RAX301 Injection — DRUG
    \[⁶⁴Cu\]Cu-RAX301 Injection is a PSMA-targeted PET radiodiagnostic agent administered as a single intravenous injection. In Phase I, participants will receive an administered activity of either 5 ± 10% mCi or 8 ± 10% mCi. Serial PET/CT imaging will be performed at approximately 1, 4, 8, 24, and 48 hours after administration for biodistribution and radiation dosimetry assessments, with imaging characteristics evaluated at 4 ± 1 hours and 24 ± 2 hours. In Phase II, participants will receive the administered activity selected based on Phase I and undergo PET/CT imaging at 4 ± 1 hours and 24 ± 2 hours after administration.

Study Details

This is a prospective, open-label, multicenter, Phase I/II exploratory diagnostic imaging study to evaluate the safety, tolerability, radiation dosimetry, pharmacokinetics, biodistribution, imaging characteristics, and preliminary diagnostic performance of \[⁶⁴Cu\]Cu-RAX301 Injection in patients with prostate cancer. Phase I will evaluate two administered activity levels of \[⁶⁴Cu\]Cu-RAX301 Injection in participants scheduled to undergo radical prostatectomy and pelvic lymph node dissection (pre-RP population) and will support selection of the administered activity for Phase II. Phase II will evaluate the selected administered activity in two independent expansion cohorts: participants with suspected recurrence or biochemical recurrence of prostate cancer and participants scheduled to undergo radical prostatectomy and pelvic lymph node dissection.

Key Dates

First listed
Aug 14, 2026
Start date
Sep 15, 2026
Status verified
Aug 2026
Primary completion
Jun 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
52 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: [⁶⁴Cu]Cu-RAX301 PET/CT
    Participants will receive a single intravenous administration of \[⁶⁴Cu\]Cu-RAX301 Injection followed by protocol-specified PET/CT imaging. In Phase I, pre-RP participants will receive either 5 ± 10% mCi or 8 ± 10% mCi \[⁶⁴Cu\]Cu-RAX301 Injection, with 6 participants in each administered activity group. The Phase I results will support selection of the administered activity for Phase II. In Phase II, participants in the BCR and pre-RP expansion cohorts will receive the selected administered activity and undergo PET/CT imaging at 4 ± 1 hours and 24 ± 2 hours after administration.

Primary Outcome Measure

The safety and tolerability of [⁶⁴Cu]Cu-RAX301 Injection - Phase 1 [ Time Frame: From administration of [⁶⁴Cu]Cu-RAX301 through Day 7 ± 2 days ]

Central Contacts

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