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

NCT01695044 | Completed Phase 2 Results DMC

• 1 other identifier: PSMA ADC 2301
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 36

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Arm 1: PSMA ADC

EXPERIMENTAL

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

Interventions

PSMA ADC DRUG

PSMA ADC administered IV at 2.5 mg/kg Q3W for 8 cycles or 2.3 mg/kg Q3W for 8 cycles.

Arm 1: PSMA ADC

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A diagnosis of metastatic castration-resistant prostate cancer.
• 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.
• b) No prior history of treatment with a cytotoxic chemotherapy regimen.
• 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.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
• Life expectancy ≥ six months.
• 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.

You may not qualify if:

• 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
• Clinically significant cardiac disease or severe debilitating pulmonary disease
• An acute infection requiring ongoing antibiotic therapy
• 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.
• History of drug and/or alcohol abuse
• History of pancreatitis

Sponsors & Collaborators

• Progenics Pharmaceuticals, Inc.: lead

Study Sites (36)

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Birmingham, Alabama, 35205, United States

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Tucson, Arizona, 85724, United States

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Burbank, California, 91505, United States

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Encinitas, California, 92024, United States

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Los Angeles, California, 90024, United States

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San Diego, California, 92123, United States

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Denver, Colorado, 80218, United States

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New Haven, Connecticut, 06520, United States

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Norwalk, Connecticut, 06856, United States

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Port Saint Lucie, Florida, 34952, United States

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Honolulu, Hawaii, 96819, United States

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Fairway, Kansas, 66205, United States

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New Orleans, Louisiana, 70115, United States

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Baltimore, Maryland, 21201, United States

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Baltimore, Maryland, 21205, United States

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Rockville, Maryland, 20850, United States

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Boston, Massachusetts, 02111, United States

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Ann Arbor, Michigan, 28109, United States

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Rochester, Minnesota, 55905, United States

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Omaha, Nebraska, 68130, United States

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Las Vegas, Nevada, 89169, United States

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Lake Success, New York, 11042, United States

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New York, New York, 10065, United States

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Rochester, New York, 14642, United States

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Stony Brook, New York, 11794, United States

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Huntersville, North Carolina, 28078, United States

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Raleigh, North Carolina, 27607, United States

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Cleveland, Ohio, 44195, United States

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Pittsburgh, Pennsylvania, 15232, United States

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Providence, Rhode Island, 02906, United States

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Greenville, South Carolina, 29605, United States

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Myrtle Beach, South Carolina, 29572, United States

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Memphis, Tennessee, 38120, United States

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Dallas, Texas, 75390, United States

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Norfolk, Virginia, 23502, United States

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Seattle, Washington, 98101, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

PSMA ADC

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Vincent A. DiPippo
• Organization: Progenics Pharmaceuticals, Inc.

vdipippo@progenics.com

(646) 975-2502

Study Officials

• Vivien Wong, PhD

  Progenics Pharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2012
• First Posted: September 27, 2012
• Study Start: September 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: February 1, 2015
• Last Updated: March 24, 2017
• Results First Posted: February 23, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (36)