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

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

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400082946
Enrollment
Unknown
Registered
2024-04-11
Start date
2024-04-16
Completion date
Unknown
Last updated
2024-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate cancer

Interventions

Single:Administration of Study drug ZA-001

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: (1) Age = 18 years. (2) Have progressive mCRPC with histologically or cytologically confirmed adenocarcinoma of the prostate, and have documented PSA and/or radiographic progression. (3) have Ga 68 PSMA-11 PET/CT PSMA positive lesions. (4) ECOG 0 to 1. (5) Previous castration treatment and keep castration with testosterone level. (6) Adequate hematological and organ function.

Exclusion criteria

Exclusion criteria: (1) Less than 4 weeks since last myelosuppressive therapy; (2) With active or uncontrolled infection; (3) 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. (4) Previously known to have a history of allergy, hypersensitivity, or intolerance to radioactive drugs; or known to be allergic to ethanol. (5) 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.

Design outcomes

Primary

MeasureTime frame
Biodistribution;The incidence and severity of adverse events (AEs);

Countries

China

Contacts

Public ContactRong Tian

Department of Nuclear Medicine, West China Hospital of Sichuan University

rongtiannuclear@126.com+86 189 8060 1586

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026