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Castrate Resistant Prostate Cancer (CRPC)Phase 1NCT00868595

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

A Phase 1 study testing BPX-101 and AP1903 in people with Castrate Resistant Prostate Cancer (CRPC), run by Bellicum Pharmaceuticals at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
BPX-101 and AP1903
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteUnited States
Study dates
Apr 2009to Mar 2012
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Texas Health Science Center Houston, CRU

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: A Phase I, Non-randomized, Multiple Dose, Dose Escalation Study of the Safety, PK, PD and Efficacy of Therapeutic Vaccine, BP-GMAX-CD1, Plus Activating Agent, AP1903, in Patients With Castrate Resistant Prostate Cancer

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.

Read the detailed description

Patients will be screened within 6 weeks prior to Week 1. A total of 3 cohorts, consisting of 3 to 6 patients each, are planned to receive five to eight intradermal (ID) injections totaling 1 mL up to 1.6mL of BPX-101 at 3 doses levels for an initial 6 doses.

Being tested
BPX-101, AP1903

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BPX-101Biological

    Also called N/Ap

    Vaccine

  • AP1903Drug

    Also called N/Ap

    Activating agent, infusion

Study groups in NCT00868595
Study groupRoleWhat they receive
Dose escalationExperimentalCohort 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.
Receives: Biological: BPX-101; Drug: AP1903

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 1 Year

  2. 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).

    Measured: 1 Year

Secondary outcomes (7)

  1. Pharmacokinetics of AP1903

    To determine the pharmacokinetics of AP1903 when administered 24 hours after BPX-101

    Measured: 1 Year

  2. Immune responses and their association with clinical outcome

    To assess immune responses and their association with clinical outcome as measured by changes in levels of interferon gamma (IFN)-producing T cells, the cytotoxic T lymphocyte (CTL) response, cytokines (IFN, IL-4, IL-10), activation markers, and other markers

    Measured: 2 Years

  3. PSA response and PSA dynamics

    To assess PSA response and PSA dynamics (change in velocity, doubling time)

    Measured: 1 Year

  4. Number of circulating tumor cells (CTC)

    To assess reduction in the number of circulating tumor cells (CTC)

    Measured: 1 Year

  5. Cancer-related pain

    To assess cancer-related pain

    Measured: 1 Year

  6. Pain medication usage

    To assess pain medication usage

    Measured: 1 Year

  7. Preliminary efficacy of BPX-101 at the maximum tolerated dose (MTD)

    To determine preliminary efficacy of BPX-101 at the maximum tolerated dose (MTD), based on tumor assessments using computed tomography (CT) or magnetic resonance imaging (MRI) and radionuclide bone scans

    Measured: 2 Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2009 (estimated)
  2. Study startApr 2009
  3. Primary completionJul 2011
  4. Study completionMar 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00868595
Sponsor's protocol ID
BP-PC-001
Status last verified
Oct 2019
First submitted
24 Mar 2009
Last updated
8 Oct 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BPX-101 and AP1903 in people with Castrate Resistant Prostate Cancer (CRPC), run by Bellicum Pharmaceuticals at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose of BPX-101 and AP1903 (time frame: 1 Year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00868595.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2019.

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