Phase 2
Completed N=9
An Open-label Extension Study of PSMA ADC 2301 in mCRPC
Source: ClinicalTrials.gov NCT02020135 ↗Enrolled (actual)
9
Serious AEs
11.1%
Results posted
Feb 2017
Primary outcomePrimary: Percentage of Participants With Total Serum PSA Response — 67; 33; 33; 0 % of responders
Summary
PSMA ADC 2301EXT is an open-label study to further assess the anti-tumor activity as measured by radiographic imaging and biomarkers, safety and tolerability of Prostate Specific Membrane Antigen Antibody Drug Conjugate (PSMA ADC) in subjects with mCRPC. Subjects who have participated in the PSMA ADC 2301 study and who, in the opinion of the Principal Investigator are likely to benefit from continued treatment with PSMA ADC are eligible for the PSMA ADC 2301 extension study. Subjects who are benefiting from treatment may be able to receive up to an additional eight to sixteen doses (every 3 weeks) of PSMA ADC.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Total Serum PSA Response |
67; 33; 33; 0 | — |
| PRIMARY CTC Response |
100; 50 | — |
| PRIMARY Overall Radiologic Response |
17; 0; 83; 100 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects who have completed the PSMA ADC 2301 study and who, in the opinion of the investigator, are likely to benefit from continued treatment with PSMA ADC
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- If chemically castrated, subjects must agree to stay on androgen-deprivation therapy for the duration of the study
- If applicable, men must agree to commit to the use of a medically acceptable method of birth control (e.g., spermicide in conjunction with a barrier such as a condom) or sexual abstinence for the duration of the study, including 30 days after the last dose of study drug
Exclusion Criteria
- An acute infection requiring ongoing antibiotic therapy (e.g., UTI, indwelling catheter or other potential site(s) of infection)
- History of significant hypersensitivity reactions to PSMA ADC or any of its components, or to any prior investigational or approved monoclonal antibodies (mAbs), immunoglobulin (Ig) fusion proteins (e.g., circulating neutralizing antibodies), or ADC
- Clinically significant cardiac disease or severe debilitating pulmonary disease
- Any recent or ongoing medical condition that may interfere with a subject's participation or compliance with the study or evaluation of PSMA ADC
Data sourced from ClinicalTrials.gov (NCT02020135). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.