Evaluate Safety, Whole-Body Distribution and Radiation Dosimetry in Metastatic Castration Resistant Prostate Cancer

NCT06359821 | Completed Early Phase 1

• 1 other identifier: Z-001
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

A Study to Evaluate Safety, Whole-Body Distribution and Radiation Dosimetry of ZA-001, an Alpha-particle-emitting (At211) Radiopharmaceutical, in metastatic castration resistant prostate cancer

Conditions

Metastatic Prostate Cancer

Keywords

PSMA positive metastatic prostate cancer

Outcome Measures

Primary Outcomes (2)

• The absorbed radiation doses (Gray [Gy] /Megabecquerel [MBq] )for whole body and organ

  SPECT/CT will be scanned following administration of the ZA-001

  24 hours

• Adverse Event

  Number of participants with Adverse Events as a measure of safety and tolerability

  1 week

Study Arms (1)

Single dose

EXPERIMENTAL

ZA-001, single dose

Drug: ZA-001

Interventions

ZA-001 DRUG

Study drug ZA-001 administered via intravenous injection.

Single dose

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants provide signed informed consent and confirm that they are able and willing to comply with all protocol requirements.
• Participants must be ≥18 years of age and competent to give informed consent.
• Participants must have progressive mCRPC with histologically or cytologically confirmed adenocarcinoma of the prostate. Participants must have documented PSA and/or radiographic progression.
• Participants must have Gallium 68 PSMA-11 (Ga 68 PSMA-11) Positron Emission Tomography (PET)/Computed Tomography (CT) prostate-specific membrane antigen (PSMA) positive lesions ≤ 30 days prior to beginning study therapy.
• Participant has not received any form of prostate-cancer directed therapy since undergoing screening PSMA scan.
• Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
• Participants must have a life expectancy of more than 3 months.
• Effective castration with testosterone level of \<50 ng/dL and plan to continue with chronic medical or surgical castration.
• Participants must have adequate hematological and organ function.

You may not qualify if:

• Participants with any medical condition or other circumstances that, in the opinion of the investigator, would preclude participation in this study, compromise obtaining reliable data, achieving study objectives, or completion.
• Pathological findings consistent with small cell and/or neuroendocrine carcinoma of the prostate or any other histology not consistent with prostate adenocarcinoma.
• Participants with any PSMA-negative metastatic lesion these criteria were ineligible.
• Less than 4 weeks since last myelosuppressive therapy (including prior radiotherapy or prior treatment with 223Radium, 89Strontium or 153Samarium containing compounds).
• With active or uncontrolled infection.
• Have used any other investigational drugs within 4 weeks or 5 half-lives (whichever is shorter) prior to the start of the study treatment, or have used any investigational medical devices within 4 weeks prior to the start of the study treatment, and plan to receive other investigational drugs or medical devices during the course of this study.
• Previously known to have a history of allergy, hypersensitivity, or intolerance to radioactive drugs; or known to be allergic to ethanol.
• Participants who have a pregnant partner or are capable of fathering a child and who are unwilling to take precautions to prevent potential harm to the fetus or prevent pregnancy during and for 90 days after discontinuation of study treatment.

Sponsors & Collaborators

• Sichuan University: lead

Study Sites (1)

West China Hospital

Chengdu, China

Location

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

• Rong Tian, MD

  West China Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 7, 2024
• First Posted: April 11, 2024
• Study Start: May 17, 2024
• Primary Completion: October 14, 2024
• Study Completion: October 14, 2024
• Last Updated: February 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)