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CompletedNCT01414283Updated Nov 1, 2013

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

A Phase 1 interventional study of PSMA ADC in Prostate Cancer, sponsored by Progenics Pharmaceuticals, Inc.. Completed at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-11-01.

Sponsored by Progenics Pharmaceuticals, Inc. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
52
Allocation
Non-randomized
Ages
18 Years and older
Sex
Male
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Study 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.

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Conditions studied

  • Prostate Cancer

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In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's enrollment of 52 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Progenics Pharmaceuticals, Inc. is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
52 participants (actual)

Study arms

  • Experimental
    Arm 1

    Drug: PSMA ADC

Interventions

  • DrugPSMA ADC

    PSMA ADC administered IV

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What researchers measure

Primary outcomes

  1. Determine the maximum tolerated dose of PSMA ADC

    Time frame: 13 weeks

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Study locations

1 site
  • Progenics Pharmaceuticals, Inc.
    Tarrytown, New York 10591, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 1, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01414283
Lead sponsor
Progenics Pharmaceuticals, Inc.
Responsible party
Sponsor
First posted
Aug 11, 2011
Start date
Oct 2008
Primary completion
Apr 2013
Completion
Sep 2013
Last update
Nov 1, 2013

Study contacts

Robert J Israel, MD
study director · Progenics Pharmaceuticals, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.

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