Metastatic Pancreatic AdenocarcinomaPhase 1NCT05484011
A Maintenance Therapy Study of Odetiglucan With CDX-1140 in Patients With Metastatic Pancreatic Ductal Adenocarcinoma
A Phase 1 study testing odetiglucan and CDX-1140 in people with Metastatic Pancreatic Adenocarcinoma, run by HiberCell, Inc. at 4 sites in United States.
Trial summary
The primary objective of this maintenance therapy study is to identify the maximum tolerated dose (MTD) and/ or recommended Phase 2 dose (RP2D), and evaluate the safety, tolerability, and dose-limiting toxicities (DLTs) of odetiglucan in combination with CDX-1140 in patients with metastatic PDAC with evidence of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Pancreatic Adenocarcinoma
- What is being tested?
- odetiglucan and CDX-1140
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 4 sitesUnited States
- Study dates
- 15 Dec 2022to 4 Mar 2024
- 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
- Be age 18 years or older and has read, understood, and provided written informed consent and, if applicable, Health Insurance Portability and Accountability Act (HIPAA) authorization after the nature of the study has been fully explained and must be willing to comply with all study requirements and procedures.
- Histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma with metastatic disease.
- Agree to be tested for peripheral blood levels of IgG anti-beta-glucan antibody (ABA) as determined by an ELISA test prior to start of study treatment.
- Have received a minimum of 16 weeks and no more than 32 weeks of therapy (first-line chemotherapy) and experienced a CR, PR, or SD with no evidence of progression immediately before enrollment (within 14 days of first dose).
- Note: this requires at least durable stability or a reduction in tumor size by imaging. If a patient has demonstrated an imaging response to chemotherapy and has not progressed but had to discontinue chemotherapy prior to 16-32 weeks for a legitimate medical reason (as determined by the investigator), the patient may still be considered for the trial.
- Have resolution of all chemotherapy-related toxicities to pre-treatment levels with exception of alopecia (which can be ongoing) and neuropathy (which can be ≤ Grade 2).
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- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at the time of screening.
- Have the following laboratory values, without transfusions or growth factors, at Screening and within 14 days of the first dose of investigational agents:
- White blood cell count ≥2000/uL
- Absolute neutrophil count (ANC) ≥1.5 x 109/L.
- Platelet count ≥100 x 109/L.
- Hemoglobin ≥9 g/dL.
- Serum creatinine ≤1.5 mg/dL, and creatinine clearance ≥50 ml/min as measured by Cockcroft and Gault formula.
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 x institution's ULN for patients with no concurrent liver metastases, OR ≤5.0 x institution's ULN for patients with concurrent liver metastases.
- Total bilirubin ≤1.5 x ULN, except in patients with documented Gilbert's Syndrome who must have a total bilirubin ≤3 x ULN.
- Serum albumin of at least 3 g/dL.
- Have adequate coagulation function within 14 days prior to first administration of study drug on
- Day 1, as defined by either of the following criteria:
- International normalized ratio (INR) <1.5 × ULN OR for patients receiving warfarin or low molecular weight heparin, the patient must, in the investigator's opinion, be clinically stable with no evidence of active bleeding while receiving anticoagulant therapy. The INR for these patients may exceed 1.5 × ULN if that is the goal of anticoagulant therapy
- Activated partial thromboplastin time (aPTT) <1.5 × ULN unless patient is receiving anticoagulant therapy, provided prothrombin time or aPTT is within therapeutic range of intended use of anticoagulants.
- Women of childbearing potential (WOCBP) must have a negative pregnancy test (serum or urine) within the 7 days prior to study drug administration, and a negative urine pregnancy test within the 3 days before the first study drug administration, or a negative serum pregnancy test within 24 hours before the first study drug administration.
- WOCBP and male patients who are sexually active with WOCBP must agree before receiving the first dose of study drugs to use 2 highly effective methods of contraception (including a physical barrier) during the study and for 120 days after the last dose of study drug, as described in the body of the protocol.
- Patients must have the ability to understand and willingness to sign a written informed consent document.
Who cannot join
- Previous exposure to odetiglucan (Imprime PGG).
- Previous exposure to CD40 antibodies or any other immunomodulatory agent for the treatment of cancer.
- Received chemotherapy within the 14 days prior to initiation of study treatment.
- Concomitant antineoplastic systemic chemotherapy or biological therapy is not allowed.
- A history of (non-infectious) pneumonitis / interstitial lung disease or has current pneumonitis / interstitial lung disease including grade 1 asymptomatic pneumonitis noted on imaging not requiring treatment.
- Had any active or inactive autoimmune disease or syndrome (i.e., rheumatoid arthritis, moderate or severe psoriasis, multiple sclerosis, inflammatory bowel disease) that required systemic treatment in the past 2 years or who are receiving systemic therapy for an autoimmune or inflammatory disease (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs).
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- Note: Exceptions include patients with vitiligo or resolved childhood asthma/atopy, hypothyroidism stable on hormone replacement, controlled asthma, Type I diabetes, Graves' disease, or Hashimoto's disease, or with medical monitor approval.
- An uncontrolled concurrent illness, including an ongoing or active infection, symptomatic congestive heart failure (New York Heart Association class III or IV), unstable angina, uncontrolled hypertension, cardiac arrhythmia, interstitial lung disease or uncontrolled diabetes.
- QT interval corrected for heart rate using Fridericia's (QTcF) method >450 msec for males and >460 msec for females.
- A history of myocardial infarction within 6 months or a history of arterial thromboembolic event within 3 months of the first dose of investigational agent.
- A history of human immunodeficiency virus (HIV), hepatitis B (HB), or hepatitis C, except for the following:
- Patients with anti-HB core antibody but with undetectable HB virus deoxyribonucleic acid (DNA) and negative for HB surface antigen
- Patients with resolved or treated hepatitis C virus (HCV) (i.e., HCV antibody positive but undetectable HCV RNA).
- Received concurrent or prior use of an immunosuppressive agent within 14 days of the first dose of investigational agent, with the following exceptions and notes:
- Systemic steroids at physiologic doses (equivalent to dose of 10 mg oral prednisone) are permitted.
- Intranasal, inhaled, topical intra-articular, and ocular corticosteroids with minimal systemic absorption are permitted.
- Transient course of steroids may be approved by the Medical Monitor on a case by case basis, dependent on dose, timing and reason.
- Active, untreated central nervous system (CNS) metastases or a history of clinically manifested central nervous system (CNS) metastases.
- Note: Patients with brain metastases identified at Screening may be rescreened after the lesion(s) have been appropriately treated; patients with treated brain metastases should be neurologically stable for 4 weeks post-treatment and prior to study enrollment, and off corticosteroids for at least 2 weeks before administration of study drugs, and treated lesions should demonstrate no new growth on the re-screening scan
- Known or suspected leptomeningeal disease or cord compression. Product: Odetiglucan and CDX-1140 11 Protocol/Amendment No.: PGG-PAN2111, Amd.000 Confidential - HiberCell Inc.
- Had major surgery as determined by the investigator within 4 weeks before the first dose of study drug. Surgery requiring local/epidural anesthesia must be completed at least 72 hours before study drug administration and patients should be recovered.
- Other prior malignancy, except for adequately treated basal or squamous cell skin cancer or in situ cancers; or any other cancer from which the patient has been disease-free for at least 3 years.
- Received another investigational agent within the shorter of 4 weeks or 5 half-lives before the first dose of investigational agents.
- Received a live attenuated vaccine within 28 days before the first dose of investigational agent, and patients, if enrolled, should not receive live vaccines during the study or for 30 days after the last dose of investigational agent.
- Females who are pregnant or lactating or who intend to become pregnant during participation in the study are not eligible to participate.
- Known alcohol or drug abuse.
- Any clinically significant psychiatric, social, or medical condition that, in the opinion of the investigator, could increase the patient's risk, interfere with protocol adherence, or affect the patient's ability to give informed consent.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
University of Pennsylvania, Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, 84112
HonorHealth Research Institute
Scottsdale, Arizona, 85258
About this study
Official title: P1b, Open-Label, Safety, Tolerability, Efficacy Study of a Soluble Beta-glucan Odetiglucan in Combination w/ a CD40 Agonist (CDX-1140) in Patients w/ Metastatic Pancreatic Adenocarcinoma Whose Disease Did Not Progress During 1st-Line Chemo
The primary objective of this maintenance therapy study is to identify the maximum tolerated dose (MTD) and/ or recommended Phase 2 dose (RP2D), and evaluate the safety, tolerability, and dose-limiting toxicities (DLTs) of odetiglucan in combination with CDX-1140 in patients with metastatic PDAC with evidence of response or stable disease following a minimum of 16 and no more than 32 weeks of chemotherapy.
Up to 45 patients will be enrolled and dosed (30 patients in Part A and 15 in Part B).
Read the detailed description
This is a multiple institution, open-label, 2-part Phase 1b study to determine the MTD (and/ or RP2D), safety, tolerability, and preliminary efficacy of the combination of odetiglucan and CDX-1140 for the treatment of patients with metastatic PDAC with evidence of response or stable disease during a minimum of 16 and no more than 32 weeks of therapy immediately prior to study enrollment. Part A will identify the MTD and/ or RP2D in two cohorts of patients enrolled per ABA status (Cohort 1=ABA+ and Cohort 2=ABA-) and Part B will assess an alternative dosing regimen of RP2D in an anti-beta glucan antibody ABA+, ABA- or ABA mixed population (ABA+ and ABA-) based on observations in Part A.
Product: Odetiglucan and CDX-1140 5 Protocol/Amendment No.: PGG-PAN2111, Amd.0010 Confidential - HiberCell Inc.
In Part A, a 3 + 3 de-escalation design will be used to determine the MTD of CDX-1140 when administered in combination with odetiglucan (the starting dose for CDX-1140 is that anticipated to be the recommended phase 2 dose (RP2D) based on prior Phase 1 clinical assessment). Two cohorts of patients will be enrolled (ABA+ and ABA-) and proceed independently through the 3+3 de-escalation assessment; up to 30 patients will be enrolled. The following 2 treatment cohorts will be evaluated for safety, tolerability, and preliminary efficacy:
- ABA+: Patients with ABA value ≥20 mcg/mL ABA
- ABA-: Patients with ABA value <20 mcg/mL ABA
Both cohorts will initiate at Dose Level 1 and de-escalate to Dose Level -1 based on the respective 21-day DLT period:
- Dose Level 1: Odetiglucan 4 mg/kg IV plus CDX-1140 1.5 mg/kg
- Dose Level -1: Odetiglucan 4 mg/kg IV plus CDX-1140 0.72 mg/kg Treatment will be administered in 3-week cycles. Odetiglucan will be administered weekly on Days 1, 8, and 15 of each cycle followed ~15-30 minutes later by administration of CDX-1140 1.5 mg/kg or 0.72 mg/kg IV Day 1 of each cycle.
Part B, if opened, will enroll up to 15 patients to receive odetiglucan 4 mg/kg plus the CDX-1140 RP2D identified in Part A. As in Part A, treatment will be administered in 3-week cycles, however, both odetiglucan and CDX-1140 will be administered on Day 1 of each cycle (no odetiglucan administration on Days 8 and 15 as in Part A). If the RP2D differs between Cohort 1 and Cohort 2 at the end of Part A, the Sponsor in consult with the SMC, may select a single RP2D to investigate or investigate both RP2Ds. If a larger total enrollment is required, the protocol will be amended to support.
- Conditions
- Metastatic Pancreatic Adenocarcinoma
- Being tested
- odetiglucan, CDX-1140
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
odetiglucanBiological
Also called Imprime, BTH-1677, Imprime PGG
Odetiglucan is a soluble, β-1,3/1,6 glucan isolated from the cell wall of a proprietary Saccharomyces cerevisiae yeast strain. Odetiglucan acts as a Pathogen-Associated Molecular Pattern (PAMP).
CDX-1140Biological
A fully human agonist anti-CD40 monoclonal antibody
| Study group | Role | What they receive |
|---|---|---|
| Part A | Experimental | Patients will have regularly scheduled study visits on days 1, 8, and 15 of each cycle. On Day 1 patients will receive odetiglucan and CDX-1140. On Days 8 \& 15 only odetiglucan. Additional study visits may be required during some cycles for safety, efficacy, and translational assessments. Patients will dose to confirmed progression, a safety event or other administrative reason requiring discontinuation; all patients are allowed to dose up to 2 years (patients continuing to derive benefit may stay on treatment longer following consultation between Investigator and Sponsor). Following discontinuation patients will be followed up to 1 year. Receives: Biological: odetiglucan; Biological: CDX-1140 |
| Part B | Experimental | Patients will have regularly scheduled study visits on day 1 of each cycle. On Day 1 patients will receive odetiglucan and CDA-1140. Additional study visits may be required during some cycles for safety, efficacy, and translational assessments. Patients will dose to confirmed progression, a safety event or other administrative reason requiring discontinuation; all patients are allowed to dose up to 2 years (patients continuing to derive benefit may stay on treatment longer following consultation between Investigator and Sponsor). Following discontinuation patients will be followed up to 1 year. Receives: Biological: odetiglucan; Biological: CDX-1140 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose
Determination of MTD of odetiglucan + CDX-1140
Measured: Within 24 months of last patient enrolled
Secondary outcomes (4)
Duration of Response
Duration of response following treatment with odetiglucan + CDX-1140
Measured: Within 24 months of last patient enrolled
Overall Response Rate
ORR per RECIST v1.1 and immune-RECIST (iRECIST) following treatment with odetiglucan + CDX-1140
Measured: Within 24 months of last patient
Median Progression Free Survival and Progression Free Survival at 6 Months
Median progression free survival and progression free survival at 6 months by RECIST v1.1 following treatment with odetiglucan + CDX-1140
Measured: Within 36 months of last patient enrolled
Median Overall Survival and Overall Survival at 1 Year
Median OS and OS at 1 year following treatment with odetiglucan + CDX-1140
Measured: Within 36 months of last patient enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study start15 Dec 2022
- Primary completion4 Mar 2024
- Study completion4 Mar 2024
Why it stopped: sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Pancreatic AdenocarcinomaStudies 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- 3 + 3 de-escalation design
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- HiberCell, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Celldex Therapeutics
- Responsible party
- Sponsor
- Investigators
- Mark O'Hara, Study chair, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05484011
- Sponsor's protocol ID
- PGG-PAN2111
- Status last verified
- Sep 2023
- First submitted
- 15 Jul 2022
- Last updated
- 10 Apr 2024
- Results posted
- No
- 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 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- P1b, Open-Label, Safety, Tolerability, Efficacy Study of a Soluble Beta-glucan Odetiglucan in Combination w/ a CD40 Agonist (CDX-1140) in Patients w/ Metastatic Pancreatic Adenocarcinoma Whose Disease Did Not Progress During 1st-Line Chemo
- ClinicalTrials.gov ID
- NCT05484011
- Acronym / sponsor ID
- PGG-PAN2111
- Conditions
- Metastatic Pancreatic Adenocarcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: sponsor decision
- Enrolment
- 5 participants (actual)
- Lead sponsor
- HiberCell, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Celldex Therapeutics
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 4 Mar 2024 (actual)
- Study completion
- 4 Mar 2024 (actual)
- First posted
- 2 Aug 2022 (actual)
- 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.
The primary objective of this maintenance therapy study is to identify the maximum tolerated dose (MTD) and/ or recommended Phase 2 dose (RP2D), and evaluate the safety, tolerability, and dose-limiting toxicities (DLTs) of odetiglucan in combination with CDX-1140 in patients with metastatic PDAC with evidence of response or stable disease following a minimum of 16 and no more than 32 weeks of chemotherapy.
Up to 45 patients will be enrolled and dosed (30 patients in Part A and 15 in Part B).
Detailed description
This is a multiple institution, open-label, 2-part Phase 1b study to determine the MTD (and/ or RP2D), safety, tolerability, and preliminary efficacy of the combination of odetiglucan and CDX-1140 for the treatment of patients with metastatic PDAC with evidence of response or stable disease during a minimum of 16 and no more than 32 weeks of therapy immediately prior to study enrollment. Part A will identify the MTD and/ or RP2D in two cohorts of patients enrolled per ABA status (Cohort 1=ABA+ and Cohort 2=ABA-) and Part B will assess an alternative dosing regimen of RP2D in an anti-beta glucan antibody ABA+, ABA- or ABA mixed population (ABA+ and ABA-) based on observations in Part A.
Product: Odetiglucan and CDX-1140 5 Protocol/Amendment No.: PGG-PAN2111, Amd.0010 Confidential - HiberCell Inc.
In Part A, a 3 + 3 de-escalation design will be used to determine the MTD of CDX-1140 when administered in combination with odetiglucan (the starting dose for CDX-1140 is that anticipated to be the recommended phase 2 dose (RP2D) based on prior Phase 1 clinical assessment). Two cohorts of patients will be enrolled (ABA+ and ABA-) and proceed independently through the 3+3 de-escalation assessment; up to 30 patients will be enrolled. The following 2 treatment cohorts will be evaluated for safety, tolerability, and preliminary efficacy:
- ABA+: Patients with ABA value ≥20 mcg/mL ABA
- ABA-: Patients with ABA value <20 mcg/mL ABA
Both cohorts will initiate at Dose Level 1 and de-escalate to Dose Level -1 based on the respective 21-day DLT period:
- Dose Level 1: Odetiglucan 4 mg/kg IV plus CDX-1140 1.5 mg/kg
- Dose Level -1: Odetiglucan 4 mg/kg IV plus CDX-1140 0.72 mg/kg Treatment will be administered in 3-week cycles. Odetiglucan will be administered weekly on Days 1, 8, and 15 of each cycle followed ~15-30 minutes later by administration of CDX-1140 1.5 mg/kg or 0.72 mg/kg IV Day 1 of each cycle.
Part B, if opened, will enroll up to 15 patients to receive odetiglucan 4 mg/kg plus the CDX-1140 RP2D identified in Part A. As in Part A, treatment will be administered in 3-week cycles, however, both odetiglucan and CDX-1140 will be administered on Day 1 of each cycle (no odetiglucan administration on Days 8 and 15 as in Part A). If the RP2D differs between Cohort 1 and Cohort 2 at the end of Part A, the Sponsor in consult with the SMC, may select a single RP2D to investigate or investigate both RP2Ds. If a larger total enrollment is required, the protocol will be amended to support.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 3 + 3 de-escalation design
| Arm | Type | Receives |
|---|---|---|
| Part A | Experimental | Biological: odetiglucan, Biological: CDX-1140Patients will have regularly scheduled study visits on days 1, 8, and 15 of each cycle. On Day 1 patients will receive odetiglucan and CDX-1140. On Days 8 \& 15 only odetiglucan. Additional study visits may be required during some cycles for safety, efficacy, and translational assessments. Patients will dose to confirmed progression, a safety event or other administrative reason requiring discontinuation; all patients are allowed to dose up to 2 years (patients continuing to derive benefit may stay on treatment longer following consultation between Investigator and Sponsor). Following discontinuation patients will be followed up to 1 year. |
| Part B | Experimental | Biological: odetiglucan, Biological: CDX-1140Patients will have regularly scheduled study visits on day 1 of each cycle. On Day 1 patients will receive odetiglucan and CDA-1140. Additional study visits may be required during some cycles for safety, efficacy, and translational assessments. Patients will dose to confirmed progression, a safety event or other administrative reason requiring discontinuation; all patients are allowed to dose up to 2 years (patients continuing to derive benefit may stay on treatment longer following consultation between Investigator and Sponsor). Following discontinuation patients will be followed up to 1 year. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Be age 18 years or older and has read, understood, and provided written informed consent and, if applicable, Health Insurance Portability and Accountability Act (HIPAA) authorization after the nature of the study has been fully explained and must be willing to comply with all study requirements and procedures.
- Histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma with metastatic disease.
- Agree to be tested for peripheral blood levels of IgG anti-beta-glucan antibody (ABA) as determined by an ELISA test prior to start of study treatment.
- Have received a minimum of 16 weeks and no more than 32 weeks of therapy (first-line chemotherapy) and experienced a CR, PR, or SD with no evidence of progression immediately before enrollment (within 14 days of first dose).
- Have resolution of all chemotherapy-related toxicities to pre-treatment levels with exception of alopecia (which can be ongoing) and neuropathy (which can be ≤ Grade 2).
Key exclusion criteria (27 listed)
- Previous exposure to odetiglucan (Imprime PGG).
- Previous exposure to CD40 antibodies or any other immunomodulatory agent for the treatment of cancer.
- Received chemotherapy within the 14 days prior to initiation of study treatment.
- A history of (non-infectious) pneumonitis / interstitial lung disease or has current pneumonitis / interstitial lung disease including grade 1 asymptomatic pneumonitis noted on imaging not requiring treatment.
- Had any active or inactive autoimmune disease or syndrome (i.e., rheumatoid arthritis, moderate or severe psoriasis, multiple sclerosis, inflammatory bowel disease) that required systemic treatment in the past 2 years or who are receiving systemic therapy for an autoimmune or inflammatory disease (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs).
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 |
|---|---|---|
| odetiglucanAlso: Imprime, BTH-1677, Imprime PGGOdetiglucan is a soluble, β-1,3/1,6 glucan isolated from the cell wall of a proprietary Saccharomyces cerevisiae yeast strain. Odetiglucan acts as a Pathogen-Associated Molecular Pattern (PAMP). | Biological | Part A, Part B |
| CDX-1140A fully human agonist anti-CD40 monoclonal antibody | Biological | Part A, Part B |
Primary outcome
Maximum Tolerated Dose
Time frame: Within 24 months of last patient enrolled
Determination of MTD of odetiglucan + CDX-1140
4 secondary outcomes
Duration of Response
Time frame: Within 24 months of last patient enrolled
Overall Response Rate
Time frame: Within 24 months of last patient
Median Progression Free Survival and Progression Free Survival at 6 Months
Time frame: Within 36 months of last patient enrolled
Median Overall Survival and Overall Survival at 1 Year
Time frame: Within 36 months of last patient enrolled
Results and safety
The study was stopped early (reason given: sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- 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.
Mark O'Hara study chair
University of Pennsylvania
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 odetiglucan and CDX-1140 in people with Metastatic Pancreatic Adenocarcinoma, run by HiberCell, 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 23 inclusion and 27 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 10 Apr 2024. 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?
The study was stopped early (reason given: sponsor decision). 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 (time frame: Within 24 months of last patient enrolled). 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 10 Apr 2024.