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

• ClinicalTrials.gov Identifier: NCT01695044
• Recruitment Status: Completed
• First Posted: September 27, 2012
• Results First Posted: February 23, 2017
• Last Update Posted: March 24, 2017
• Sponsor: Progenics Pharmaceuticals, Inc.
• Information provided by (Responsible Party): Progenics Pharmaceuticals, Inc.

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Prostate Cancer	Drug: PSMA ADC	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 119 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 2, Open-label, Multicenter Study of PSMA ADC in Subjects With Metastatic Castration-resistant Prostate Cancer
• Study Start Date: September 2012
• Actual Primary Completion Date: October 2014
• Actual Study Completion Date: February 2015

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Percentage of Participants With Total Serum PSA Response [ Time Frame: 24 Weeks ]
   Total serum prostate-specific antigen (PSA) response was defined as any decrease from baseline of at least 30% or 50%.
2. CTC Response [ Time Frame: 24 Weeks ]
   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%.
3. Overall Radiologic Response [ Time Frame: 24 weeks ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Alabama

Birmingham, Alabama, United States, 35205

United States, Arizona

Tucson, Arizona, United States, 85724

United States, California

Burbank, California, United States, 91505

Encinitas, California, United States, 92024

Los Angeles, California, United States, 90024

San Diego, California, United States, 92123

United States, Colorado

Denver, Colorado, United States, 80218

United States, Connecticut

New Haven, Connecticut, United States, 06520

Norwalk, Connecticut, United States, 06856

United States, Florida

Port St. Lucie, Florida, United States, 34952

United States, Hawaii

Honolulu, Hawaii, United States, 96819

United States, Kansas

Fairway, Kansas, United States, 66205

United States, Louisiana

New Orleans, Louisiana, United States, 70115

United States, Maryland

Baltimore, Maryland, United States, 21201

Baltimore, Maryland, United States, 21205

Rockville, Maryland, United States, 20850

United States, Massachusetts

Boston, Massachusetts, United States, 02111

United States, Michigan

Ann Arbor, Michigan, United States, 28109

United States, Minnesota

Rochester, Minnesota, United States, 55905

United States, Nebraska

Omaha, Nebraska, United States, 68130

United States, Nevada

Las Vegas, Nevada, United States, 89169

United States, 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

United States, North Carolina

Huntersville, North Carolina, United States, 28078

Raleigh, North Carolina, United States, 27607

United States, Ohio

Cleveland, Ohio, United States, 44195

United States, Pennsylvania

Pittsburgh, Pennsylvania, United States, 15232

United States, Rhode Island

Providence, Rhode Island, United States, 02906

United States, South Carolina

Greenville, South Carolina, United States, 29605

Myrtle Beach, South Carolina, United States, 29572

United States, Tennessee

Memphis, Tennessee, United States, 38120

United States, Texas

Dallas, Texas, United States, 75390

United States, Virginia

Norfolk, Virginia, United States, 23502

United States, Washington

Seattle, Washington, United States, 98101

Sponsors and Collaborators

Progenics Pharmaceuticals, Inc.

Investigators

• Study Director: Vivien Wong, PhD; Progenics Pharmaceuticals, Inc.

More Information

• Responsible Party: Progenics Pharmaceuticals, Inc.
• ClinicalTrials.gov Identifier: NCT01695044
• Other Study ID Numbers: PSMA ADC 2301
• First Posted: September 27, 2012
• Results First Posted: February 23, 2017
• Last Update Posted: March 24, 2017
• Last Verified: February 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Additional relevant MeSH terms:

Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Prostatic Diseases