Status:
TERMINATED
Safety and Targeting of Anti-hk2 Antibody in mCRPC
Lead Sponsor:
SpectronRX
Collaborating Sponsors:
Invicro
Janssen Research & Development, LLC
Conditions:
Castration-Resistant Prostatic Cancer
Metastatic Disease
Eligibility:
MALE
18+ years
Phase:
EARLY_PHASE1
Brief Summary
This is an imaging trial, to develop h11B6 as a therapeutic radiopharmaceutical for men with mCRPC. This imaging study will be conducted to confirm the safety and estimate the mass amount of antibody...
Detailed Description
It is the intent to develop h11B6 as a therapeutic radiopharmaceutical for men with mCRPC. This Phase 0 study will be conducted to confirm the safety, estimate the mass amount, and confirm in vivo tum...
Eligibility Criteria
Inclusion
- Subjects with mCRPC will be eligible if they meet the following criteria:
- Eastern Cooperative Oncology Group (ECOG) ≤ 1
- Histologically or cytologically confirmed adenocarcinoma of the prostate
- Castrate levels of testosterone (\<50 ng/dL \[1.74 nmol/L\])
- Metastatic disease documented by imaging
- Documented progressive mCRPC with androgen involvement as defined by - Prostate Cancer Working Group 3
- Acceptable laboratory parameters
- At least 28 days since administration of any therapeutic radioactive isotope
- Able to tolerate the conditions required to perform imaging studies (e.g., lying flat for at least 1 hour).
Exclusion
- Known hypersensitivity to proteins, or other allergic diathesis that, in the opinion of the investigator, makes an immune response to humanized antibody likely
- Radiotherapy or immunotherapy within 30 days, or single fraction of palliative radiotherapy within 14 days of administration of study agent
- Any condition that, in the opinion of the Investigator, would impair the subject's ability to comply with study procedures and required study visits
- Active, symptomatic, or untreated brain metastases.
Key Trial Info
Start Date :
September 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 6 2023
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT04116164
Start Date
September 18 2019
End Date
July 6 2023
Last Update
September 25 2023
Active Locations (1)
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1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021