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

NCT00868595 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2019-10-08

No results posted yet for this study

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)

Interventions

BIOLOGICAL

BPX-101

Vaccine

DRUG

AP1903

Activating agent, infusion

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    collaborator OTHER

  • The University of Texas Health Science Center, Houston

    collaborator OTHER

  • Memorial Hermann Hospital

    collaborator OTHER

  • Baylor College of Medicine

    collaborator OTHER

  • Bellicum Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Guru Sonpavde, MD · University of Texas Health Science Center Houston - CCTS

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2011-07-31
Completion
2012-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00868595 on ClinicalTrials.gov