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

A Phase 1 Dose-escalation Study of PSMA ADC in Subjects With Progressive, Castration-resistant, Metastatic Prostate Cancer

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01414283

Enrollment

Registered

2011-08-11

Start date

2008-10-31

Completion date

2013-09-30

Last updated

2013-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Brief summary

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.

Interventions

DRUGPSMA ADC

PSMA ADC administered IV

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

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

Design outcomes

Primary

Measure	Time frame
Determine the maximum tolerated dose of PSMA ADC	13 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026