MTD Study of Vaccine BP-GMAX-CD1 Plus AP1903 to Treat Castrate Resistant Prostate Cancer

Completed · Phase 1

Conditions studied: Castrate Resistant Prostate Cancer (CRPC)

In brief

This is a Phase I, non-randomized, multiple-dose, 3+3 dose-escalation study of the safety, pharmacokinetics, biomarkers, preliminary efficacy and patient-reported outcomes of therapeutic vaccine, BPX-101 (formerly BP-GMAX-CD1), plus activating agent, AP1903, in patients with castrate resistant prostate cancer.

Key facts

Study ID

NCT00868595

Run by

Bellicum Pharmaceuticals

People needed

18

Starts

2009-04-01

Expected to finish

2012-03-01

Last updated by the study team

2019-10-08

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Males ≥ 18 years of age
• Histological diagnosis of adenocarcinoma of the prostate
• Documented evidence of distant metastasis of disease
• No more than 1 prior chemotherapeutic, biologic or combination treatment regimen (including vitamin D analogues) for CRPC. If previously treated, patients must be recovered from all toxicities prior to entry into the study.
• Patients must have current or historical evidence of disease progression concomitant with surgical (orchiectomy) or medical castration (LHRH analogue); anti-androgen withdrawal (4 weeks for flutamide and 6 weeks for nilutamide or bicalutamide) is necessary only for patients on antiandrogens and a duration of response to antiandrogens > 3months;
• Testosterone < 50 ng/dL achieved via medical or surgical castration. Patients receiving medical castration therapy must continue such therapy throughout the study.
• Adequate hematologic, renal and liver function:
• Negative serology tests for human immunodeficiency virus (HIV-1 and 2), human T-cell lymphotropic virus (HTLV-1), hepatitis B surface antigen (HBsAg) and hepatitis C (HCV)
• Karnofsky Performance Score (KPS) ≥ 70%
• Life expectancy > 6 months
• Written informed consent obtained prior to the initiation of study procedures

You may not qualify if…

• The presence of brain metastases, pleural effusions or ascites
• Pathologic long-bone fractures, imminent pathologic long-bone fracture (cortical erosion on radiography > 50%), or spinal cord compression
• A history of stage III or greater cancer, excluding prostate cancer. Basal or squamous cell skin cancers must have been adequately treated and the patient must be disease-free at the time of registration. Patients with a history of stage I or II other cancers must have been adequately treated and been disease-free for 3 years at the time of registration.
• More than 1 prior chemotherapy, biologic or combination treatment regimen (including vitamin D analogues) for CRPC
• Any treatment with radiopharmaceuticals, e.g. Strontium-89 and Samarium-153
• Ketoconazole or antiandrogens (flutamide, nilutamide, bicalutamide) within 2 weeks prior to registration. Patients who demonstrate an anti-androgen withdrawal response, defined as a > 25% drop in PSA within 4 weeks (flutamide) or 6 weeks (nilutamide, bicalutamide) of stopping a non-steroidal anti-androgen, are not eligible until the PSA rises above the nadir observed after anti-androgen withdrawal.
• Initiation of bisphosphonate therapy within 28 days prior to registration. Patients taking bisphosphonates should not have their dosing regimen altered unless medically warranted.
• A requirement for systemic steroid or other immunosuppressive therapy for any reason.
• Treatment with any of the following medications or interventions < 28 days prior to Screening
• Treatment with any investigational vaccine within 2 years prior to Screening, or treatment with any other investigational product within 28 days prior to Screening
• Any antibiotic therapy or infection within 1 week prior to Screening, including unexplained fever (temperature ≥ 100.5F or 38.1C)
• History of autoimmune disease
• Serious ongoing chronic or acute illness
• Any medical intervention or other condition which, in the opinion of the Principal Investigator and/or the Bellicum Medical Monitor, could compromise adherence with study requirements
• Other Criteria Apply however are not listed

Where it is running

• University of Texas Health Science Center Houston, CRU — Houston, Texas, United States

Full record on ClinicalTrials.gov

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