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Trial Title:
Evaluate Safety, Whole-Body Distribution and Radiation Dosimetry in Metastatic Castration Resistant Prostate Cancer
NCT ID:
NCT06359821
Condition:
Metastatic Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
PSMA positive metastatic prostate cancer
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Enrolling by invitation
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
ZA-001
Description:
Study drug ZA-001 administered via intravenous injection.
Arm group label:
Single dose
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
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Participants provide signed informed consent and confirm that they are able and
willing to comply with all protocol requirements.
2. Participants must be ≥18 years of age and competent to give informed consent.
3. Participants must have progressive mCRPC with histologically or cytologically
confirmed adenocarcinoma of the prostate. Participants must have documented PSA
and/or radiographic progression.
4. 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.
5. Participant has not received any form of prostate-cancer directed therapy since
undergoing screening PSMA scan.
6. Participants must have an Eastern Cooperative Oncology Group (ECOG) performance
status of 0 to 1.
7. Participants must have a life expectancy of more than 3 months.
8. Effective castration with testosterone level of <50 ng/dL and plan to continue with
chronic medical or surgical castration.
9. Participants must have adequate hematological and organ function.
Exclusion Criteria:
1. 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.
2. Pathological findings consistent with small cell and/or neuroendocrine carcinoma of
the prostate or any other histology not consistent with prostate adenocarcinoma.
3. Participants with any PSMA-negative metastatic lesion these criteria were
ineligible.
4. Less than 4 weeks since last myelosuppressive therapy (including prior radiotherapy
or prior treatment with 223Radium, 89Strontium or 153Samarium containing compounds).
5. With active or uncontrolled infection.
6. 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.
7. Previously known to have a history of allergy, hypersensitivity, or intolerance to
radioactive drugs; or known to be allergic to ethanol.
8. 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.
Gender:
Male
Minimum age:
18 Years
Maximum age:
100 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
West China Hospital
Address:
City:
Chengdu
Country:
China
Start date:
May 17, 2024
Completion date:
April 15, 2026
Lead sponsor:
Agency:
Sichuan University
Agency class:
Other
Source:
Sichuan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06359821
