Prostate-specific Membrane Antigen Antibody-Drug Conjugate in Subjects With Prostate Cancer

Progenics Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Prostate Cancer

Treatments: Drug: PSMA ADC

Study type: Interventional

Funder types: Industry

Identifiers

NCT01414283

PSMA ADC 1301

Details and patient eligibility

About

Prostate-specific Membrane Antigen Antibody-Drug Conjugate (PSMA ADC) 1301 is an open-label, dose-escalation phase 1 study of PSMA ADC administered IV in subjects with progressive, castration-resistant, metastatic prostate cancer that has progressed after prior taxane therapy. For all subjects, PSMA ADC will be administered in four repeating cycles.

Enrollment: 52 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. A diagnosis of progressive, castration-resistant, metastatic prostate cancer.
2. Prior chemotherapy regimens, one of which contains taxane.
3. 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. Any prior treatment with any other therapy targeting PSMA
4. History of drug and/or alcohol abuse

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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52 participants in 1 patient group

Arm 1

Experimental group

Treatment:

Drug: PSMA ADC