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

Progenics Pharmaceuticals, Inc.10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prostate Cancer

Interventions

PSMA ADCDRUG

PSMA ADC administered IV

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Progenics Pharmaceuticals, Inc.

Tarrytown, New York, United States

Outcomes

Primary Outcomes

Number of subjects with Adverse Events

Safety and tolerability of PSMA ADC as measured by all adverse events, hematology, blood chemistry, and urine values, vital signs, electrocardiogram, and physical exam.

Time frame: 39 weeks

Data from ClinicalTrials.gov

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