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

NCT07765940 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: COPRA424
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

Brief 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

Prostate Cancer

Keywords

pre-RP; BCR; PSMA PET; [⁶⁴Cu]Cu-RAX301; Prostate Cancer; RAX301; Biochemical Recurrence; Pre-Radical Prostatectomy; Copper-64; Radiopharmaceutical Imaging; PET/CT

Outcome Measures

Primary Outcomes (5)

• The safety and tolerability of [⁶⁴Cu]Cu-RAX301 Injection - Phase 1

  Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) following administration of \[⁶⁴Cu\]Cu-RAX301 Injection, together with clinically relevant changes from baseline in physical examinations, vital signs, clinical laboratory assessments, and 12-lead electrocardiograms.

  From administration of [⁶⁴Cu]Cu-RAX301 through Day 7 ± 2 days

• Participant-Level Correct Detection Rate of [⁶⁴Cu]Cu-RAX301 PET/CT - Phase II BCR Cohort

  Participant-level correct detection rate (CDR) of \[⁶⁴Cu\]Cu-RAX301 PET/CT at 4 ± 1 hours and 24 ± 2 hours after administration, based on the prespecified composite standard of truth. CDR is defined as the proportion of scanned participants with at least one true-positive region among participants with at least one evaluable reference-standard assessment.

  PET/CT at 4 ± 1 hours and 24 ± 2 hours after administration; standard-of-truth assessment generally through Day 60, with follow-up up to approximately 180 days when PSA response following local radiotherapy is used for confirmation

• Region-Level Positive Predictive Value of [⁶⁴Cu]Cu-RAX301 PET/CT - Phase II BCR Cohort

  Region-level positive predictive value (PPV) of \[⁶⁴Cu\]Cu-RAX301 PET/CT at 4 ± 1 hours and 24 ± 2 hours after administration. PPV will be determined among PET-positive regions with an evaluable standard-of-truth status.

  PET/CT at 4 ± 1 hours and 24 ± 2 hours after administration; standard-of-truth assessment generally through Day 60, with follow-up up to approximately 180 days when applicable

• Participant-Level Sensitivity of [⁶⁴Cu]Cu-RAX301 PET/CT - Phase II pre-RP Cohort

  Participant-level sensitivity of \[⁶⁴Cu\]Cu-RAX301 PET/CT at 4 ± 1 hours and 24 ± 2 hours after administration, using postsurgical histopathology from radical prostatectomy and/or pelvic lymph node dissection as the reference standard.

  PET/CT at 4 ± 1 hours and 24 ± 2 hours after administration; postsurgical histopathology collected within 28 days after administration

• Participant-Level Specificity of [⁶⁴Cu]Cu-RAX301 PET/CT - Phase II pre-RP Cohort

  Participant-level specificity of \[⁶⁴Cu\]Cu-RAX301 PET/CT at 4 ± 1 hours and 24 ± 2 hours after administration, using postsurgical histopathology from radical prostatectomy and/or pelvic lymph node dissection as the reference standard.

  PET/CT at 4 ± 1 hours and 24 ± 2 hours after administration; postsurgical histopathology collected within 28 days after administration

Secondary Outcomes (6)

• The biodistribution and radiation dosimetry characteristics of [⁶⁴Cu]Cu-RAX301 Injection at 5 ± 10% mCi, and the pharmacokinetic (PK) characteristics of [⁶⁴Cu]Cu-RAX301 Injection at two administered activity levels, 5 ± 10% mCi and 8 ± 10% mCi.

  Pre-dose through approximately 48 hours after administration

• The imaging characteristics of [⁶⁴Cu]Cu-RAX301 Injection at two PET/CT imaging time points, 4 ± 1 h and 24 ± 2 h after administration - Phase 1.

  4 ± 1 hours and 24 ± 2 hours after administration

• Preliminary Diagnostic Performance of [⁶⁴Cu]Cu-RAX301 PET/CT - Phase I

  PET/CT at 4 ± 1 hours and 24 ± 2 hours after administration; postsurgical histopathology collected within 28 days after administration

• PET/CT Uptake and Biodistribution Parameters - Phase II

  4 ± 1 hours and 24 ± 2 hours after administration

• Inter-Reader and Intra-Reader Agreement for [⁶⁴Cu]Cu-RAX301 PET/CT

  Based on PET/CT images acquired at 4 ± 1 hours and 24 ± 2 hours after administration

Study Arms (1)

[⁶⁴Cu]Cu-RAX301 PET/CT

EXPERIMENTAL

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.

Drug: [⁶⁴Cu]Cu-RAX301 Injection

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.

[⁶⁴Cu]Cu-RAX301 PET/CT

Eligibility Criteria

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

You may qualify if:

• Phase I
• Participants must meet all of the following criteria to be eligible for enrollment:
• Able to provide written informed consent prior to initiation of any study-specific procedures.
• Male participants aged ≥18 years.
• Histologically confirmed prostate cancer.
• ECOG performance status 0 to 2.
• Life expectancy of at least 6 months.
• Clinically assessed as scheduled to undergo radical prostatectomy and pelvic lymph node dissection (including patients with localized disease, regional lymph node metastases, or oligometastatic prostate cancer), with no contraindications to surgery.
• Participants must meet one of the following risk categories: unfavorable intermediate-risk, high-risk, or very high-risk prostate cancer, as defined according to the NCCN Guidelines (Version 2026, Version 5; PROS-2):
• Unfavorable intermediate-risk prostate cancer, defined as meeting any of the following criteria:
• ISUP Grade Group (GG) 3; or
• GG 2 with ≥50% of biopsy cores positive for prostate cancer; and/or
• Presence of ≥2 intermediate-risk factors, including clinical stage cT2b or cT2c and PSA 10-20 ng/mL.
• High-risk prostate cancer, defined as meeting at least one high-risk feature but not meeting criteria for very high-risk disease, including:
• Clinical stage cT3a; or

You may not qualify if:

• Phase I
• Participants meeting any of the following criteria will be excluded from the study:
• Known or suspected hypersensitivity to the active component(s) of \[⁶⁴Cu\]Cu-RAX301 Injection or any of its excipients.
• Inability to complete \[⁶⁴Cu\]Cu-RAX301 Injection PET/CT imaging as required by the protocol.
• Participation in another interventional clinical trial prior to signing the informed consent form, within 5 half-lives of the investigational product, or current participation in another interventional clinical trial; or prior participation in a radiopharmaceutical clinical trial with a washout period of less than 3 months prior to signing informed consent.
• Receipt of any intravenous iodinated contrast agent within 24 hours prior to administration of the investigational product, or receipt of any high-density oral contrast agent (e.g., barium sulfate) within 5 days prior to dosing. Oral water-soluble contrast agents (e.g., compound diatrizoate meglumine oral solution) are permitted.
• Prior treatment with androgen deprivation therapy (ADT) or any other neoadjuvant therapy.
• Receipt of high-energy gamma radiation (\>300 keV) prior to dosing, within 5 half-lives of the investigational product.
• QTcF interval ≥470 msec on 12-lead ECG (corrected using Fridericia's formula).
• Any medical condition that, in the investigator's judgment, may compromise participant safety, protocol compliance, or interpretation of study results.
• Phase II
• Known or suspected hypersensitivity to the active component(s) of \[⁶⁴Cu\]Cu-RAX301 Injection or any of its excipients.
• Inability to complete \[⁶⁴Cu\]Cu-RAX301 Injection PET/CT imaging as required by the protocol.
• Participation in another interventional clinical trial prior to signing informed consent, within 5 half-lives of the investigational product, or current participation in another interventional clinical trial; or prior participation in a radiopharmaceutical clinical trial with a washout period of less than 3 months prior to signing informed consent.
• Receipt of any intravenous iodinated contrast agent within 24 hours prior to administration of the investigational product, or receipt of any high-density oral contrast agent (e.g., barium sulfate) within 5 days prior to dosing. Oral water-soluble contrast agents (e.g., compound diatrizoate meglumine oral solution) are permitted.

Sponsors & Collaborators

• RadAlliance Therapeutics, Inc: lead
• Shanghai Junkanglitai Biosciences Co. Ltd.: collaborator
• Shanghai Zhongshan Hospital: collaborator

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Hongcheng Shi, MD PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guangzhou Han, PhD, MD

CONTACT

7167481409; guangzhou.han@radalliancetx.com

Min Hong, PhD

CONTACT

min.hong@radalliancetx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a single-arm, Phase I/II exploratory diagnostic imaging study. In Phase I, participants scheduled for radical prostatectomy and pelvic lymph node dissection will receive one of two administered activity levels of \[⁶⁴Cu\]Cu-RAX301 Injection (5 ± 10% mCi or 8 ± 10% mCi) to evaluate safety, dosimetry, pharmacokinetics, imaging characteristics, and preliminary diagnostic performance and to support selection of an administered activity for Phase II. Phase II will evaluate the selected administered activity in two independent expansion cohorts: participants with suspected or biochemical recurrence of prostate cancer and participants scheduled for radical prostatectomy and pelvic lymph node dissection.

Study Record Dates

• First Submitted: August 10, 2026
• First Posted: August 14, 2026
• Study Start (Estimated): September 15, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 14, 2026

Record last verified: 2026-08