Progenics Pharmaceuticals has initiated enrollment of patients in a multi-center, open-label, Phase II clinical trial of PMSA ADC in up to 75 patients with metastatic, castration-resistant prostate cancer (mCRPC).
According to the company’s media release,
PSMA ADC is a novel compound designed to deliver a cell-killing drug selectively to prostate cancer cells by targeting prostate specific membrane antigen (PSMA), a validated biomarker of prostate cancer that is expressed on the surface of those cells (as well as on blood vessels supplying other solid tumors). PSMA ADC consists of a fully human monoclonal antibody, which binds PSMA, linked to a cytotoxic drug, monomethyl auristatin E (MMAE), which inhibits cell proliferation by disrupting the cellular “backbone” required for replication. The antibody-drug conjugate is designed to be absorbed by the cell and release active anti-cancer drug, thereby destroying the malignant cell.
The company is scheduled to present updated data from a Phase I clinical trial of this product at the EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics to be held November 6-9 in Dublin, Ireland. Early Phase 1 data were presented at the annual meeting of the American Society of Clinical Oncology (ASCO) earlier this year based on doses of PSMA ADC given to heavily pretreated men with mCRPC. Doses of up to and including 2.5 mg/kg were said to be generally well tolerated.
We have not (yet) been able to find any information about the scheduled Phase II trial on the ClinicalTrials.gov web site. It is therefore not clear exactly what the eligibility criteria are for participation in this study. However, trial participants will receive a total of eight doses of drug at 2.5 mg/kg, and the study endpoints will include evaluation of responses to therapy based PSA levels, circulating tumor cell (CTC) levels, changes in the amount of observable bone, visceral, and nodal metastases, and pain levels. The clinical safety and toxicity of PMSA ADC will also be assessed.
Because there is no information on ClinicalTrials.gov, the only center that we know is recruiting patients at this time is at Yale University Medical Center in Connecticut. For additional information about this trial, patients may wish to contact the company directly (by phone at 914-789-2800 or by e-mail).