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

NCT00868595 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: BP-PC-001
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Castrate Resistant Prostate Cancer (CRPC)

Outcome Measures

Primary Outcomes (2)

• Maximum tolerated dose of BPX-101 and AP1903

  To determine the maximum tolerated dose (MTD) of BPX-101 and AP1903 when administered 24 hours apart

  1 Year

• Safety and tolerability of BPX-101 and AP1903

  To determine other measures of safety and tolerability of BPX-101 and AP1903 when administered 24 hours apart to patients with castrate resistant prostate cancer (CRPC).

  1 Year

Secondary Outcomes (7)

• Pharmacokinetics of AP1903

  1 Year

• Immune responses and their association with clinical outcome

  2 Years

• PSA response and PSA dynamics

  1 Year

• Number of circulating tumor cells (CTC)

  1 Year

• Cancer-related pain

  1 Year

Study Arms (1)

Dose escalation

EXPERIMENTAL

Cohort 1: BPX-101, 4 x 10\*6 cells administered every other week for 6 cycles Cohort 2: BPX-101, 12.5 x 10\*6 cells administered every other week for 6 cycles Cohort 3: BPX-101, 25 x 10\*6 cells administered every other week for 6 cycles Cohort 4: BPX-101, 25 x 10\*6 cells administered every 4 weeks for 3 cycles At 24 hours after each vaccination, a single dose of the activating agent, AP1903 for Injection, will be administered at a fixed dose of 0.4 mg/kg via intravenous (IV) infusion over 2 hours.

Biological: BPX-101; Drug: AP1903

Interventions

BPX-101 BIOLOGICAL

Vaccine

Also known as: N/Ap

Dose escalation

AP1903 DRUG

Activating agent, infusion

Also known as: N/Ap

Dose escalation

Eligibility Criteria

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

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

Sponsors & Collaborators

• Bellicum Pharmaceuticals: lead
• M.D. Anderson Cancer Center: collaborator
• The University of Texas Health Science Center, Houston: collaborator
• Memorial Hermann Hospital: collaborator
• Baylor College of Medicine: collaborator

Study Sites (1)

University of Texas Health Science Center Houston, CRU

Houston, Texas, 77030, United States

Location

Related Links

• Bellicum Pharmaceuticals Home Page

MeSH Terms

Interventions

AP 1903 reagent

Study Officials

• Guru Sonpavde, MD

  University of Texas Health Science Center Houston - CCTS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2009
• First Posted: March 25, 2009
• Study Start: April 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: March 1, 2012
• Last Updated: October 8, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)