A Study of PSMA ADC in Subjects With Metastatic Castration-resistant Prostate Cancer (mCRPC)

A Phase 2, Open-label, Multicenter Study of PSMA ADC in Subjects With Metastatic Castration-resistant Prostate Cancer

PSMA ADC 2301 is a Phase 2, open-label, study to assess the anti-tumor activity and tolerability of Prostate Specific Membrane Antigen Antibody Drug Conjugate (PSMA ADC) in two groups of subjects with metastatic castration-resistant prostate cancer (mCRPC). One group comprises subjects who must have received at least one taxane-containing chemotherapy regimen (e.g. docetaxel, cabazitaxel). The second group comprises subjects who are cytotoxic chemotherapy-naïve. Subjects who are cytotoxic chemotherapy-naïve must have received and progressed on-, be ineligible for, refused, have an intolerance to-, or not have access to Radium-223. Both groups of subjects must also have received and progressed on abiraterone acetate and/or enzalutamide. If a subject is unable to receive abiraterone acetate and/or enzalutamide, Sponsor approval is required for participation in the study. Subjects will receive up to eight doses of PSMA ADC approximately once every three weeks.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: PSMA ADC

• Study Type: Interventional
• Enrollment (Actual): 119
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
  • Arizona
    • Tucson, Arizona, United States, 85724
  • California
    • Burbank, California, United States, 91505
    • Encinitas, California, United States, 92024
    • Los Angeles, California, United States, 90024
    • San Diego, California, United States, 92123
  • Colorado
    • Denver, Colorado, United States, 80218
  • Connecticut
    • New Haven, Connecticut, United States, 06520
    • Norwalk, Connecticut, United States, 06856
  • Florida
    • Port St. Lucie, Florida, United States, 34952
  • Hawaii
    • Honolulu, Hawaii, United States, 96819
  • Kansas
    • Fairway, Kansas, United States, 66205
  • Louisiana
    • New Orleans, Louisiana, United States, 70115
  • Maryland
    • Baltimore, Maryland, United States, 21201
    • Baltimore, Maryland, United States, 21205
    • Rockville, Maryland, United States, 20850
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
  • Michigan
    • Ann Arbor, Michigan, United States, 28109
  • Minnesota
    • Rochester, Minnesota, United States, 55905
  • Nebraska
    • Omaha, Nebraska, United States, 68130
  • Nevada
    • Las Vegas, Nevada, United States, 89169
  • New York
    • Lake Success, New York, United States, 11042
    • New York, New York, United States, 10065
    • Rochester, New York, United States, 14642
    • Stony Brook, New York, United States, 11794
  • North Carolina
    • Huntersville, North Carolina, United States, 28078
    • Raleigh, North Carolina, United States, 27607
  • Ohio
    • Cleveland, Ohio, United States, 44195
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15232
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
  • South Carolina
    • Greenville, South Carolina, United States, 29605
    • Myrtle Beach, South Carolina, United States, 29572
  • Tennessee
    • Memphis, Tennessee, United States, 38120
  • Texas
    • Dallas, Texas, United States, 75390
  • Virginia
    • Norfolk, Virginia, United States, 23502
  • Washington
    • Seattle, Washington, United States, 98101

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. A diagnosis of metastatic castration-resistant prostate cancer.

2. a) Prior history of treatment with at least one taxane-containing chemotherapy regimen (e.g. docetaxel, cabazitaxel). If a subject has received more than two cytotoxic chemotherapy regimens, Sponsor approval is required for study participation.

   OR

   b) No prior history of treatment with a cytotoxic chemotherapy regimen.

3. Must have received and progressed on abiraterone acetate and/or enzalutamide. If subject is unable to receive abiraterone acetate and/or enzalutamide, Sponsor approval is required for participation in the study.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
5. Life expectancy ≥ six months.
6. Cytotoxic chemotherapy-naïve subjects ONLY must have received and progressed on-, be ineligible for, refused, have an intolerance to-, or not have access to Radium-223.

Exclusion Criteria:

1. Treatment within 30 days prior to first dose of study drug of the following:

   • External Radiation therapy
   • Radiopharmaceuticals
   • Cytotoxic chemotherapy
   • Treatment with an investigational agent
2. Clinically significant cardiac disease or severe debilitating pulmonary disease
3. An acute infection requiring ongoing antibiotic therapy
4. Any prior treatment with PSMA ADC or other therapies targeting PSMA, or other antibody drug conjugate (ADC) products that contain monomethyl auristatin E (MMAE) (e.g., brentuximab vedotin, glembatumumab vedotin, ASG-5ME, RG7450) unless approved by Sponsor.
5. History of drug and/or alcohol abuse
6. History of pancreatitis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Arm 1: PSMA ADC; Prostate Specific Membrane Antigen Antibody Drug Conjugate (PSMA ADC) administered IV at 2.5 mg/kg Q3W for 8 cycles or 2.3 mg/kg Q3W for 8 cycles.	Drug: PSMA ADC; PSMA ADC administered IV at 2.5 mg/kg Q3W for 8 cycles or 2.3 mg/kg Q3W for 8 cycles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Total Serum PSA Response	Total serum prostate-specific antigen (PSA) response was defined as any decrease from baseline of at least 30% or 50%.	24 Weeks
CTC Response	Circulating tumor cells (CTC) response was examined at two levels: at least 30% decrease or at least 50% decrease in CTC levels. Response was defined as any decrease from baseline of at least 30% or 50%.	24 Weeks
Overall Radiologic Response	Overall radiologic response was measured prior to the first dose of study drug, at predose of cycle 5, and at the end of study. Imaging techniques used at screening were used throughout the study. The preferred imaging techniques include: bone scan, contrast enhanced CT of chest, contrast enhanced CT of pelvis, and contrast enhanced CT of upper & lower abdomen. Best overall radiologic response (confirmed), target and non-target lesions, was defined as responses in bone, visceral or nodal metastases according to the Modified Response Evaluation Criteria (RECIST 1.1). The best overall radiologic response is the best response recorded from the start of the treatment until disease progression/recurrence (taking, as reference for progressive disease, the smallest measurements recorded since the treatment started). The subject's best response assignment depended on the achievement of both measurement and confirmation criteria.	24 weeks

Collaborators and Investigators

• Sponsor: Progenics Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (ACTUAL): October 1, 2014
• Study Completion (ACTUAL): February 1, 2015

Study Registration Dates

• First Submitted: September 25, 2012
• First Submitted That Met QC Criteria: September 26, 2012
• First Posted (ESTIMATE): September 27, 2012

Study Record Updates

• Last Update Posted (ACTUAL): March 24, 2017
• Last Update Submitted That Met QC Criteria: February 21, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: PSMA ADC 2301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO