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A Phase II Open Label Multicenter Study of PSMA ADC in Subjects with Castration-resistant Metastatic Prostate Cancer

Conditions

Cancer | Prostate

Trial Phase

Phase II

Trial Purpose and Description

Trial Purpose

The objective of PSMA ADC 2301 in subjects with progressive, CRMPC is to assess the anti-tumor activity and tolerability of PSMA ADC.


Participation Guidelines

Age:
18 Years and older
Gender:
Male

Eligibility Criteria

Inclusion Criteria:

  • Males, age &ge18 years
  • < 150 kg
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
  • Life expectancy &ge six months
  • Must have histologically or cytologically confirmed prostate adenocarcinoma.
  • A castrate level of serum testosterone (<50 ng/dL) at screening (testosterone should be measured by the central laboratory by mass spectrometry if colorimetric assay is greater than 50).

  • Prior and/or ongoing androgen-deprivation therapy consisting of either orchiectomy or luteinizing hormone-releasing hormone (LHRH) agonists, with or without an antiandrogen. If chemically castrated, subjects must agree to stay on LHRH agonist medication for the duration of the study.

  • If applicable, men must agree to commit to the use of a medically acceptable method of birth control (e.g., spermicide in conjunction with a barrier such as a condom) or sexual abstinence for the duration of the study, including 30 days after the last dose of study drug.

  • 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.

  • Must have received and progressed on abiraterone acetate and/or enzalutamide and must wait a minimum of 30 days from their last dose of abiraterone acetate and/or enzalutamide prior to receiving their first dose of PSMA ADC. If subject is unable to receive abiraterone acetate and/or enzalutamide, Sponsor approval is required for participation in the study.

  • Willing and able to provide written informed consent and written authorization for use and release of health and research information.

Exclusion Criteria:

  • Predominant histologically or cytologically confirmed neuroendocrine prostate cancer.
  • Presence of nonprostate primary malignant neoplasm within the five years prior to screening except for: keratinocyte (non-melanoma) (i.e., basal cell, squamous cell) carcinoma of the skin or low-grade papillary transitional cell carcinoma of the bladder
  • Treatment within 30 days prior to first dose of study drug of the following (30 day washout period required): External radiation therapy, Radiopharmaceuticals, Cytotoxic chemotherapy, Treatment with an investigational agent.
  • An acute infection (e.g., UTI, indwelling catheter or other potential sites of infection) requiring systemic antibiotic therapy within 30 days prior to first dose of study drug.
  • Any toxicity &ge grade 2 (non-laboratory) (NCI CTCAE, Version 4.03) prior to first dose of study drug.
  • Prior treatment with PSMA ADC or other therapies targeting PSMA, or other antibody drug conjugate (ADC) products that contain MMAE (e.g., brentuximab vedotin, glembatumumab vedotin, ASG-5ME, RG7450) unless approved by Sponsor
  • History of significant hypersensitivity reactions to PSMA ADC or any of its components, to any prior investigational or approved monoclonal antibodies (mAbs) immunoglobulin (Ig) fusion proteins (e.g., circulating neutralizing antibodies), or ADCs.
  • The calculated QTc with either Bazett or Fridericia corrections &ge 500 msec.
  • History of pancreatitis.
  • History of drug and/or alcohol abuse (DSM-IV-TR®) within five years prior to first dose of study drug.
  • Clinically significant cardiac disease (New York Heart Association Class III/IV) or severe debilitating pulmonary disease.
  • Any recent or ongoing medical condition that may interfere with a subject&rsquos participation or compliance with the study or evaluation of PSMA ADC.
Sponsor:
PSMA Development Company LLC
Dates:
01/11/2013
Last Updated:
Study HIC#:
1211011046