Prostate Cancer
Conditions
Brief summary
Prostate-specific Membrane Antigen Antibody-Drug Conjugate (PSMA ADC) 1301EXT is an open-label, nonrandomized, phase 1 extension study of PSMA ADC administered IV in subjects with progressive CMPC that has progressed after prior taxane therapy. Subjects who have participated in PSMA ADC 1301 and who, in the opinion of the PI, are likely to benefit from continued treatment with PSMA ADC will be enrolled in PSMA ADC 1301EXT.
Interventions
DRUGPSMA ADC
PSMA ADC administered IV
Sponsors
Progenics Pharmaceuticals, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects who have completed the PSMA ADC 1301 study and who, in the opinion of the investigator, have derived benefit from treatment with PSMA ADC. 2. A diagnosis of progressive, castration-resistant, metastatic prostate cancer. 3. Prior chemotherapy regimens, one of which contains taxane. 4. Eastern Cooperative Oncology Group status of 0 or 1
Exclusion criteria
1. Clinically significant cardiac disease or severe debilitation pulmonary disease 2. Evidence of an active infection requiring ongoing antibiotic therapy 3. History of drug and/or alcohol abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects with Adverse Events | 39 weeks | Safety and tolerability of PSMA ADC as measured by all adverse events, hematology, blood chemistry, and urine values, vital signs, electrocardiogram, and physical exam. |
Countries
United States
Outcome results
None listed