Prostate CancerPhase 1NCT03120832
Phase 1 Trial of PAN-301-1 (SNS-301) in Cancer Patients
A Phase 1 study testing PAN-301-1 in people with Prostate Cancer, run by Sensei Biotherapeutics, Inc. at 4 sites in United States.
Trial summary
This is a Phase I, open-label, parallel design study of PAN-301-1 (SNS-301), a HAAH directed nanoparticle vaccine, given intradermally in cohorts of patients with biochemically relapsed prostate cancer, using a fixed dose escalation schema every 21 days. Read more about this study
- Who is it for?
- Ages 21 to 85 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- PAN-301-1
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 4 sitesUnited States
- Study dates
- Dec 2016to Dec 2018
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed and dated written Ethics Committee approved informed consent
- Men aged 21 to 85 years with a histologic diagnosis of prostate cancer with a biochemical relapse following definitive local therapy (RP or radiation therapy)
- Patients are not eligible or are unwilling to receive additional definitive therapy following relapse (either RP or radiation therapy)
- No prior cytotoxic chemotherapy for the current cancer
- Normal electrocardiogram (ECG) or ECG with no clinically significant findings as determined by the Principal Investigator
- Presence of biochemically relapsed prostate cancer defined as either: 1) PSA > 2 ng/mL 1 year following initial definitive treatment for prostate cancer: or, 2) PSA doubling time (greater than 0.2 ng/mL) < 12 months; or, 3) PSA velocity > 2 ng/mL/year at any time following radical prostatectomy or radiation therapy.
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- Positive expression of HAAH in either archived tumor tissue (if available) or fresh serum
- No clinical or radiologic evidence of distant metastatic disease as measured by pelvic MRI or CT scan in addition to bone scan. These studies will need to be performed within 56 (+ 7 days) days prior to the start of the study.
- No history of immunosuppressive disease
- No evidence of active autoimmune disease. Active autoimmune disease is defined as any disease process that has specifically needed administration of immune suppressive and or cytoreductive therapy currently or within the last 1 year.
- Able and willing to comply with all study procedures
Who cannot join
- PSA doubling time of < 3 months
- Participation in a clinical trial within 30 days prior to enrollment
- Prior major surgery or radiation therapy within 4 weeks of enrollment
- Any illness or condition that in the opinion of the Investigator may affect the safety of the patient or the evaluation of any study endpoint
- Screening blood counts of the following:
- Hematopoietic:
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- Absolute neutrophil count < 1500/μL, Platelets < 100,000/μL, Hemoglobin < 9 g/dL;
- Liver/Metabolic:
- Alanine aminotransferase (ALT) and aspartate transaminase (AST) > 2.5 × ULN range, Total bilirubin > 2 × ULN, Albumin < 2.8 g/dL;
- Renal:
- Creatinine clearance < 50 mL/min as predicted by the Cockcroft-Gault formula
- Subjects whose partners are WOCBP must use an adequate method of birth control while on study drug and at least for 3 weeks after discontinuation of study drug
- Current or anticipated concomitant immunosuppressive therapy (excluding nonsystemic inhaled, topical skin and/or eye drop-containing corticosteroids)
- Any concurrent condition requiring the continued use of systemic steroids (see above) or the use of immunosuppressive agents including methotrexate. All other systemic corticosteroids must be discontinued at least 4 weeks prior to first study treatment
- Receipt of any blood product within 1 month of enrollment
- Receipt of any vaccine within 4 weeks of enrollment
- Active drug or alcohol use or dependence that, in the opinion of the Investigator, would interfere with adherence to study requirements
- Been imprisoned or compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (i.e. infectious disease) illness
- Patients who have a history of coagulopathies, thrombosis or who are receiving active anticoagulation for any condition, such as but not limited to, artificial heart valves, atrial fibrillation, etc.
- Any other conditions judged by the Investigator that would limit the evaluation of a subject
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Dr. James J. Elist
Beverly Hills, California, 90211
Urology Centers of Alabama
Homewood, Alabama, 35209
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
GU Research Network/Urology Cancer Center
Omaha, Nebraska, 68130
About this study
Official title: Phase 1, Open Label Trial to Evaluate the Safety and Immunogenicity of PAN-301-1 in Cancer Patients
This is a Phase I, open-label, parallel design study of PAN-301-1 (SNS-301), a HAAH directed nanoparticle vaccine, given intradermally in cohorts of patients with biochemically relapsed prostate cancer, using a fixed dose escalation schema every 21 days.
Read the detailed description
Human aspartyl-asparaginyl-β-hydroxylase (HAAH), also known as aspartate-β-hydroxylase, is an ~86 kDa type 2 transmembrane protein that belongs to the α-ketoglutarate-dependent dioxygenase family. It is a highly conserved enzyme, which catalyzes the hydroxylation of aspartyl and asparaginyl residues in epidermal growth factor-like domains of proteins including Notch and homologs. HAAH was initially identified in a novel screen to identify cell surface proteins up-regulated in liver cancer. It has subsequently been detected in a diverse array of solid and blood cancers, including: liver, bile duct, brain, breast, colon, prostate, ovary, pancreas, and lung cancers as well as leukemia. HAAH is not found in significant quantities in normal tissue or in proliferative disorders.
The investigators have designed a bacteriophage lambda system to display HAAH peptides fused at the C terminus of the head protein gpD of phage lambda. The phage carry 200-300 copies of the gpD protein on their head and thus display many copies of an approximately 25 kDa molecular weight fragment of HAAH on their surface. The drug substance is one of these HAAH bacteriophage lambda constructs: HAAH-1λ (PAN-301-1).
This study evaluates the safety and immunogenicity of the PAN-301-1 vaccine in patients with biochemically-relapsed prostate cancer.
- Conditions
- Prostate Cancer
- Being tested
- PAN-301-1
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAN-301-1Biological
Also called SNS-301
| Study group | Role | What they receive |
|---|---|---|
| PAN-301-1 (SNS-301) Vaccine | Experimental | PAN-301-1 vaccine is administered intradermally in 3 cohorts of patients in a dose escalation schema every 21 days Receives: Biological: PAN-301-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Assessed by Development of Adverse Events and Dose-limiting Toxicity to Determine Maximum Tolerated Dose
Measured: Through the 21 day interval after the first dose of vaccine
Secondary outcomes (1)
Safety Assessed by Administration Site Reactions, Abnormal Laboratory Values and/or Adverse Events
Measured: Through study completion, an average of 3 months. Patients were able to continue on treatment with one patient receiving approximately 15 months of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2017
- Study startDec 2016
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Sequential
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sensei Biotherapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Accelovance
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03120832
- Sponsor's protocol ID
- PAN0216
- Status last verified
- Oct 2021
- First submitted
- 16 Feb 2017
- Last updated
- 12 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Open Label Trial to Evaluate the Safety and Immunogenicity of PAN-301-1 in Cancer Patients
- ClinicalTrials.gov ID
- NCT03120832
- Acronym / sponsor ID
- PAN0216
- Conditions
- Prostate Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Sensei Biotherapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Accelovance
- Study start
- Dec 2016
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 19 Apr 2017 (actual)
- Results
- Posted 12 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase I, open-label, parallel design study of PAN-301-1 (SNS-301), a HAAH directed nanoparticle vaccine, given intradermally in cohorts of patients with biochemically relapsed prostate cancer, using a fixed dose escalation schema every 21 days.
Detailed description
Human aspartyl-asparaginyl-β-hydroxylase (HAAH), also known as aspartate-β-hydroxylase, is an ~86 kDa type 2 transmembrane protein that belongs to the α-ketoglutarate-dependent dioxygenase family. It is a highly conserved enzyme, which catalyzes the hydroxylation of aspartyl and asparaginyl residues in epidermal growth factor-like domains of proteins including Notch and homologs. HAAH was initially identified in a novel screen to identify cell surface proteins up-regulated in liver cancer. It has subsequently been detected in a diverse array of solid and blood cancers, including: liver, bile duct, brain, breast, colon, prostate, ovary, pancreas, and lung cancers as well as leukemia. HAAH is not found in significant quantities in normal tissue or in proliferative disorders.
The investigators have designed a bacteriophage lambda system to display HAAH peptides fused at the C terminus of the head protein gpD of phage lambda. The phage carry 200-300 copies of the gpD protein on their head and thus display many copies of an approximately 25 kDa molecular weight fragment of HAAH on their surface. The drug substance is one of these HAAH bacteriophage lambda constructs: HAAH-1λ (PAN-301-1).
This study evaluates the safety and immunogenicity of the PAN-301-1 vaccine in patients with biochemically-relapsed prostate cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PAN-301-1 (SNS-301) Vaccine | Experimental | Biological: PAN-301-1PAN-301-1 vaccine is administered intradermally in 3 cohorts of patients in a dose escalation schema every 21 days |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Signed and dated written Ethics Committee approved informed consent
- Men aged 21 to 85 years with a histologic diagnosis of prostate cancer with a biochemical relapse following definitive local therapy (RP or radiation therapy)
- Patients are not eligible or are unwilling to receive additional definitive therapy following relapse (either RP or radiation therapy)
- No prior cytotoxic chemotherapy for the current cancer
- Normal electrocardiogram (ECG) or ECG with no clinically significant findings as determined by the Principal Investigator
Key exclusion criteria (20 listed)
- PSA doubling time of < 3 months
- Participation in a clinical trial within 30 days prior to enrollment
- Prior major surgery or radiation therapy within 4 weeks of enrollment
- Any illness or condition that in the opinion of the Investigator may affect the safety of the patient or the evaluation of any study endpoint
- Screening blood counts of the following:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PAN-301-1Also: SNS-301 | Biological | PAN-301-1 (SNS-301) Vaccine |
Primary outcome
Safety Assessed by Development of Adverse Events and Dose-limiting Toxicity to Determine Maximum Tolerated Dose
Time frame: Through the 21 day interval after the first dose of vaccine
1 secondary outcome
Safety Assessed by Administration Site Reactions, Abnormal Laboratory Values and/or Adverse Events
Time frame: Through study completion, an average of 3 months. Patients were able to continue on treatment with one patient receiving approximately 15 months of treatment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PAN-301-1 in people with Prostate Cancer, run by Sensei Biotherapeutics, Inc. at 4 sites 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 20 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 12 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Yes. Results are posted in the registry (first posted 12 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Safety Assessed by Development of Adverse Events and Dose-limiting Toxicity to Determine Maximum Tolerated Dose (time frame: Through the 21 day interval after the first dose of vaccine). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Nov 2021.