Phase 2
N=119
A Study of PSMA ADC in Subjects With Metastatic Castration-resistant Prostate Cancer (mCRPC)
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01695044 ↗Enrolled (actual)
119
Serious AEs
51.3%
Results posted
Feb 2017
Primary outcome: Primary: Percentage of Participants With Total Serum PSA Response — 29; 32; 11; 21 % of responders
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- PSMA ADC (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Progenics Pharmaceuticals, Inc.
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Total Serum PSA Response |
29; 32; 11; 21 | — |
| PRIMARY CTC Response |
81; 92; 74; 85 | — |
| PRIMARY Overall Radiologic Response |
26; 17; 0; 6; 13; 9 | — |
Summary
PSMA ADC 2301 is a Phase 2, open-label, study to assess the anti-tumor activity and tolerability of Prostate Specific Membrane Antigen Antibody Drug Conjugate (PSMA ADC) in two groups of subjects with metastatic castration-resistant prostate cancer (mCRPC). One group comprises subjects who must have received at least one taxane-containing chemotherapy regimen (e.g. docetaxel, cabazitaxel). The second group comprises subjects who are cytotoxic chemotherapy-naïve. Subjects who are cytotoxic chemotherapy-naïve must have received and progressed on-, be ineligible for, refused, have an intolerance to-, or not have access to Radium-223. Both groups of subjects must also have received and progressed on abiraterone acetate and/or enzalutamide. If a subject is unable to receive abiraterone acetate and/or enzalutamide, Sponsor approval is required for participation in the study. Subjects will receive up to eight doses of PSMA ADC approximately once every three weeks.
Eligibility Criteria
Inclusion Criteria
- A diagnosis of metastatic castration-resistant prostate cancer.
- a) Prior history of treatment with at least one taxane-containing chemotherapy regimen (e.g. docetaxel, cabazitaxel). If a subject has received more than two cytotoxic chemotherapy regimens, Sponsor approval is required for study participation.
OR
b) No prior history of treatment with a cytotoxic chemotherapy regimen.
- Must have received and progressed on abiraterone acetate and/or enzalutamide. If subject is unable to receive abiraterone acetate and/or enzalutamide, Sponsor approval is required for participation in the study.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- Life expectancy ≥ six months.
- Cytotoxic chemotherapy-naïve subjects ONLY must have received and progressed on-, be ineligible for, refused, have an intolerance to-, or not have access to Radium-223.
Exclusion Criteria
- Treatment within 30 days prior to first dose of study drug of the following:
- External Radiation therapy
- Radiopharmaceuticals
- Cytotoxic chemotherapy
- Treatment with an investigational agent
- Clinically significant cardiac disease or severe debilitating pulmonary disease
- An acute infection requiring ongoing antibiotic therapy
- Any prior treatment with PSMA ADC or other therapies targeting PSMA, or other antibody drug conjugate (ADC) products that contain monomethyl auristatin E (MMAE) (e.g., brentuximab vedotin, glembatumumab vedotin, ASG-5ME, RG7450) unless approved by Sponsor.
- History of drug and/or alcohol abuse
- History of pancreatitis
Data sourced from ClinicalTrials.gov (NCT01695044). 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.