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

NCT07765940 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2026-08-14

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

[⁶⁴Cu]Cu-RAX301 Injection

\[⁶⁴Cu\]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.

Sponsors & Collaborators

  • Shanghai Junkanglitai Biosciences Co. Ltd.

    collaborator UNKNOWN

  • Shanghai Zhongshan Hospital

    collaborator OTHER

  • RadAlliance Therapeutics, Inc

    lead INDUSTRY

Principal Investigators

  • Hongcheng Shi, MD PhD · Fudan University

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-15
Primary Completion
2027-06-30
Completion
2027-12-31
FDA Drug
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07765940 on ClinicalTrials.gov