Pancreatic CancerPhase 1PM-01NCT02132403
(PM-01) IMPRIME PGG® With BTH1704 and Gemcitabine for Advanced Pancreatic Cancer
A Phase 1 study testing BTH1704, IMPRIME PGG and Gemcitabine in people with Pancreatic Cancer, run by University of Illinois Chicago at 1 site in United States.
Trial summary
This Phase Ib dose escalation study will evaluate BTH1704, a monoclonal antibody that targets an aberrantly glycosylated antigen Mucin 1, and Imprime PGG, a glucan contained in yeast that is essential in triggering a leukocyte-mediated cytotoxic response towards tumor cells, in combination with gemcitabine in patients… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- BTH1704, IMPRIME PGG and Gemcitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Apr 2015
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥ 18 years
- Histologically or cytologically confirmed adenocarcinoma of the pancreas, including pancreatic adenosquamous carcinoma, pancreatic anaplastic adenocarcinoma, pancreatic signet ring carcinoma, papillary mucinous carcinoma, acinar cell carcinoma, and ampulla of vater carcinoma,that is locally advanced (not able to proceed with surgery), recurrent, or metastatic (mixed adenocarcinoma of the pancreas is acceptable where the invasive component is predominantly adenocarcinoma)
- Has measurable disease, defined as at least 1 tumor that fulfills the criteria for a target lesion according to RECIST 1.1
- Has an ECOG PS of 0, 1, or 2
- Has been off chemotherapy for > or = 2 weeks
- Has a patent biliary stent if required for biliary ductal obstruction, has adequate nutritional intake, and pain which is stable for a minimum of 24 hrs (pain score ≤ 3/10)
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- Has total bilirubin < 2 mg/dL, AST and ALT < 3.0 × ULN or < 5 x ULN for subjects with known hepatic metastases
- Has serum creatinine < 2.5 × ULN
- Has hemoglobin ≥ 9 g/dL, ANC ≥ 1.0 × 10^9/L, and platelet count ≥ 100 × 10^9/L
- Must be willing and able to comply with study
- Has read, understood and signed the ICF
- Women of childbearing potential must not be pregnant or breast-feeding. In addition, a medically acceptable method of birth control must be used or total abstinence. Women who are postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) are not considered to be WOCP.
- Men who are not surgically or medically sterile must agree to use an acceptable method of contraception. Male patients with female sexual partners who are pregnant, possibly pregnant, or who could become pregnant during the study must agree to use condoms at least 30 days after the last dose of study drug. Total abstinence is an acceptable alternative.
- Prior systemic treatments for metastatic disease are permitted, including targeted therapies, biologic response modifiers, chemotherapy, hormonal therapy, or investigational therapy.
- Availability of tissue if applicable (from the primary tumor or metastases)for banking
- Willingness to donate blood for biomarker studies
- Must have received at least one prior systemic chemotherapy on which disease progressed
Who cannot join
- Has a diagnosis of resectable pancreatic adenocarcinoma
- Had surgery within 4 weeks prior to study treatment
- Has either untreated or symptomatic CNS mets
- Has a known hypersensitivity to BTH1704, murine proteins, or any component of BTH1704
- Has a known hypersensitivity to baker's yeast
- Has had previous exposure to Imprime PGG
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- Has previously received an organ or progenitor/stem cell transplant
- Has a history of blood clots, pulmonary embolism, or DVT unless controlled by anticoagulant treatment
- Has a known history of HIV positivity or untreated \& uncontrolled hepatitis B or C
- Has any clinically significant infection
- Has any other severe, uncontrolled medical condition, including uncontrolled DM or unstable CHF or has a known or suspected allergy to the study drug
- Other severe acute or chronic medical or psychiatric conditions, or laboratory abnormality that may increase the risk associated with study participation
- Presence of any non-healing wound, fracture, or ulcer
- Has any condition that, in the opinion of the investigator, might jeopardize the safety of the patient or interfere with protocol compliance
- Has any mental or medical condition that prevents the patient from giving informed consent
- Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to gemcitabine or drugs to formulate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PM-01: Phase 1b Study of PGG Beta Glucan (Imprime PGG®) in Combination With Anti-MUC1 Antibody (BTH1704) and Gemcitabine (Gemzar®) for the Treatment of Advanced Pancreatic Cancer
This Phase Ib dose escalation study will evaluate BTH1704, a monoclonal antibody that targets an aberrantly glycosylated antigen Mucin 1, and Imprime PGG, a glucan contained in yeast that is essential in triggering a leukocyte-mediated cytotoxic response towards tumor cells, in combination with gemcitabine in patients with advanced PDAC. The three intravenous drugs are taken in tandem 4 times in a 28-day cycle. The MAD of BTH1704 (BTH, 3 dose levels) in combination with gemcitabine (Gem) and Imprime PGG (I) will be determined using a standard "3+3" design. Treatment continues until disease progression, unacceptable toxicity, physician discretion, or patient refusal.
- Conditions
- Pancreatic Cancer
- Being tested
- BTH1704, IMPRIME PGG, Gemcitabine
- Keywords
- pancreatic cancer, adenocarcinoma of the pancreas (PDAC), mixed adenocarcinoma of the pancreas, locally advanced, recurrent, metastatic
- Medical subject headings
- Pancreatic Neoplasms, Anophthalmia with pulmonary hypoplasia, Recurrence, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BTH1704Drug
Also called Humanized Human Milk Fat Globule 1 Antibody, huHMFG1, R1550, AS1402
BTH1704 at assigned doses administered on days 1, 8, 15, and 22 of a 28-day (4 week) cycle.
IMPRIME PGGDrug
Also called Beta 1,3/1,6 glucan
Imprime PGG at assigned doses administered on days 1, 8, 15, and 22 of a 28-day (4 week) cycle.
GemcitabineDrug
Also called Gemzar®
Gemcitabine on days 1, 8, and 15, at assigned doses, of a 28-day (4 week) cycle.
| Study group | Role | What they receive |
|---|---|---|
| IMPRIME PGG, BTH1704, & Gemcitabine | Experimental | Imprime PGG with BTH1704 at assigned doses administered on days 1, 8, 15, and 22 of a 28-day cycle with Gemcitabine on days 1, 8, and 15, at assigned doses, of a 28-day cycle. Receives: Drug: BTH1704; Drug: IMPRIME PGG; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD)
The primary objective of this Phase 1b study is to determine the maximal administered dose (MAD) of BTH1704 (Mucin-1 targeted antibody) in combination with gemcitabine and Imprime PGG (beta 1,3/1,6 glucan) when given to patients with advanced and previously treated pancreatic ductal adenocarcinoma (PDAC).
Measured: Up to 30 days post last dose
Secondary outcomes (2)
Adverse Effects
Characterize adverse effects (AE) of I-BTH-Gem in patients with advanced PDAC in the second and third line setting.
Measured: Up to 30 days post final dose
Disease Response based on RECIST Criteria
Evaluate clinical response of I-BTH-Gem in patients with advanced PDAC in the second and third line setting (RECIST v 1.1).
Measured: Up to 8 weeks following final dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2014 (estimated)
- Study startAug 2014
- Primary completionApr 2015
- Study completionApr 2015
Why it stopped: Drug Recall
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- HiberCell, Inc.
- Responsible party
- Principal investigator, Howard Ozer, University of Illinois Chicago
- Investigators
- Neeta Venepalli, MD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02132403
- Sponsor's protocol ID
- 2013-1115
- Acronym
- PM-01
- Status last verified
- Apr 2015
- First submitted
- 5 May 2014
- Last updated
- 1 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PM-01: Phase 1b Study of PGG Beta Glucan (Imprime PGG®) in Combination With Anti-MUC1 Antibody (BTH1704) and Gemcitabine (Gemzar®) for the Treatment of Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT02132403
- Acronym / sponsor ID
- PM-01 / 2013-1115
- Conditions
- Pancreatic Cancer
- Keywords
- pancreatic cancer, adenocarcinoma of the pancreas (PDAC), mixed adenocarcinoma of the pancreas, locally advanced, recurrent, metastatic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Drug Recall
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- HiberCell, Inc.
- Study start
- Aug 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 7 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase Ib dose escalation study will evaluate BTH1704, a monoclonal antibody that targets an aberrantly glycosylated antigen Mucin 1, and Imprime PGG, a glucan contained in yeast that is essential in triggering a leukocyte-mediated cytotoxic response towards tumor cells, in combination with gemcitabine in patients with advanced PDAC. The three intravenous drugs are taken in tandem 4 times in a 28-day cycle. The MAD of BTH1704 (BTH, 3 dose levels) in combination with gemcitabine (Gem) and Imprime PGG (I) will be determined using a standard "3+3" design. Treatment continues until disease progression, unacceptable toxicity, physician discretion, or patient refusal.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IMPRIME PGG, BTH1704, & Gemcitabine | Experimental | Drug: BTH1704, Drug: IMPRIME PGG, Drug: GemcitabineImprime PGG with BTH1704 at assigned doses administered on days 1, 8, 15, and 22 of a 28-day cycle with Gemcitabine on days 1, 8, and 15, at assigned doses, of a 28-day cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Male or female ≥ 18 years
- Histologically or cytologically confirmed adenocarcinoma of the pancreas, including pancreatic adenosquamous carcinoma, pancreatic anaplastic adenocarcinoma, pancreatic signet ring carcinoma, papillary mucinous carcinoma, acinar cell carcinoma, and ampulla of vater carcinoma,that is locally advanced (not able to proceed with surgery), recurrent, or metastatic (mixed adenocarcinoma of the pancreas is acceptable where the invasive component is predominantly adenocarcinoma)
- Has measurable disease, defined as at least 1 tumor that fulfills the criteria for a target lesion according to RECIST 1.1
- Has an ECOG PS of 0, 1, or 2
- Has been off chemotherapy for > or = 2 weeks
Key exclusion criteria (16 listed)
- Has a diagnosis of resectable pancreatic adenocarcinoma
- Had surgery within 4 weeks prior to study treatment
- Has either untreated or symptomatic CNS mets
- Has a known hypersensitivity to BTH1704, murine proteins, or any component of BTH1704
- Has a known hypersensitivity to baker's yeast
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 |
|---|---|---|
| BTH1704Also: Humanized Human Milk Fat Globule 1 Antibody, huHMFG1, R1550, AS1402BTH1704 at assigned doses administered on days 1, 8, 15, and 22 of a 28-day (4 week) cycle. | Drug | IMPRIME PGG, BTH1704, & Gemcitabine |
| IMPRIME PGGAlso: Beta 1,3/1,6 glucanImprime PGG at assigned doses administered on days 1, 8, 15, and 22 of a 28-day (4 week) cycle. | Drug | IMPRIME PGG, BTH1704, & Gemcitabine |
| GemcitabineAlso: Gemzar®Gemcitabine on days 1, 8, and 15, at assigned doses, of a 28-day (4 week) cycle. | Drug | IMPRIME PGG, BTH1704, & Gemcitabine |
Primary outcome
Maximum Tolerated Dose (MTD)
Time frame: Up to 30 days post last dose
The primary objective of this Phase 1b study is to determine the maximal administered dose (MAD) of BTH1704 (Mucin-1 targeted antibody) in combination with gemcitabine and Imprime PGG (beta 1,3/1,6 glucan) when given to patients with advanced and previously treated pancreatic ductal adenocarcinoma (PDAC).
2 secondary outcomes
Adverse Effects
Time frame: Up to 30 days post final dose
Disease Response based on RECIST Criteria
Time frame: Up to 8 weeks following final dose.
Results and safety
The study was stopped early (reason given: Drug Recall). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2015.
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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.
Neeta Venepalli, MD principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BTH1704, IMPRIME PGG and Gemcitabine in people with Pancreatic Cancer, run by University of Illinois Chicago 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 17 inclusion and 16 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: stopped early, as of the sponsor's last update on 1 May 2015. 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 was stopped early (reason given: Drug Recall). Results are not available in the source record.
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 (MTD) (time frame: Up to 30 days post last dose). 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 1 May 2015.