Pancreatic CancerPhase 1/21-BETTERNCT04825288
XB2001 in Combination With ONIVYDE + 5-FU/LV (+Folinic Acid) in Advanced Pancreatic Cancer
A Phase 1/2 study testing Phase I: XB2001 250 mg, Phase I: XB2001 500 mg and Phase I: XB2001 1000 mg in people with Pancreatic Cancer, run by XBiotech, Inc. at 30 sites in United States.
Trial summary
This trial will include 2 portions (phase 1 and phase 2). The first portion will be a Phase I, open label, dose escalation study to establish the maximum tolerated dose (MTD) of XB2001 as measured by Dose-Limiting Toxicity (DLT), in combination with ONIVYDE + LV + 5-FU chemotherapy regimen in patients with advanced… 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?
- Phase I: XB2001 250 mg, Phase I: XB2001 500 mg and Phase I: XB2001 1000 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 30 sitesUnited States
- Study dates
- 27 May 2021to 10 Jun 2025
- Phase
- Phase 1/2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed pancreatic adenocarcinoma of exocrine pancreas that is metastatic, unresectable, or recurrent
- At least one measurable lesion according to Response Evaluation Criteria in Solid Tumor V1.1
- Documented disease progression after one prior gemcitabine-based therapy OR one FOLFIRINOX and gemcitabine combination therapy
- Eastern Cooperative Oncology Group (ECOG) performance of 0 or 1 or Karnofsky performance status (KPS) ≥ 70
- Adequate hepatic, renal and bone marrow function
Who cannot join
- Clinically significant decrease in performance status (medical records) within 2 weeks of intended first dose administration
- Clinically significant GI disorders
- Severe arterial thromboembolic events less than 6 months before inclusion
- Prior Whole Brain Radiation Therapy (WBRT)
- Evidence of brain metastases
- NYHA Class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled blood pressure (defined as ≥ 160/100 mm Hg)
- Use of strong CYP3A4 inducers or inhibitors and/or UGT1A1 inhibitors within 14 days prior to Visit 1/Baseline visit.
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
United States30 sites
Texas Oncology - Arlington
Arlington, Texas, 76012
St. Vincent Frontier Cancer Center
Billings, Montana, 59102
Disney Family Cancer Center at Providence St. Joseph Medical Center
Burbank, California, 91505
TOI Clinical Research
Cerritos, California, 90703
Mary Crowley Cancer Research
Dallas, Texas, 75230
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
Virginia Cancer Specialists
Fairfax, Virginia, 22031
Revive Research - Farmington Hills
Farmington Hills, Michigan, 48334
Summit Medical Group
Florham Park, New Jersey, 07932
Providence St. Joseph Heritage - Fullerton, CA
Fullerton, California, 92835
Goshen Center for Cancer Care
Goshen, Indiana, 46526
Grand Valley Oncology
Grand Junction, Colorado, 81505
University of Tennessee Medical Center Cancer Institute
Knoxville, Tennessee, 37920
Sarah Cannon - Florida Cancer Specialists
Lake Mary, Florida, 32746
Alliance for Multispecialty Research, LLC
Merriam, Kansas, 66204
Mt. Sinai Comprehensive Cancer Center
Miami Beach, Florida, 33140
Bon Secours St. Francis Cancer Center
Midlothian, Virginia, 23114
Sarah Cannon - Tennessee Oncology
Nashville, Tennessee, 37203
Vanderbilt University
Nashville, Tennessee, 37232
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
Community Cancer Trials of Utah
Ogden, Utah, 84405
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Providence Portland
Portland, Oregon, 97213
Sarasota Memorial Hospital
Sarasota, Florida, 34239
Revive Research - Sterling Heights
Sterling Heights, Michigan, 48126
Stony Brook Cancer Center
Stony Brook, New York, 11794
Montefiore Einstein Medical Center
The Bronx, New York, 10461
Arizona Oncology Associates
Tucson, Arizona, 85711
Cleveland Clinic of Florida
Weston, Florida, 33331
About this study
Official title: A Phase I/II Randomized, Double-blind, Placebo-controlled Trial (1-BETTER) Examining XB2001 (Anti-IL-1⍺ True Human Antibody) in Combination With ONIVYDE + 5-FU/LV (+Folinic Acid) in Advanced Pancreatic Cancer
This trial will include 2 portions (phase 1 and phase 2).
The first portion will be a Phase I, open label, dose escalation study to establish the maximum tolerated dose (MTD) of XB2001 as measured by Dose-Limiting Toxicity (DLT), in combination with ONIVYDE + LV + 5-FU chemotherapy regimen in patients with advanced pancreatic cancer and to determine the recommended dose for the subsequent Phase 2 study.
The phase 2 portion will be implemented with the maximum established tolerated dose (MTD) of XB2001. The target enrollment in the phase 2 portion is 60 patients which will be randomized on a 1:1 basis to XB2001 plus ONIVYDE + LV + 5-FU (Arm 1) or placebo plus ONIVYDE + LV + 5-FU (Arm 2).
Read the detailed description
Study Title: A Phase I/II randomized, double-blind, placebo-controlled trial (1-BETTER) examining XB2001 (anti-IL-1⍺ True Human antibody) in combination with ONIVYDE + 5-FU/LV (+folinic acid) in advanced pancreatic cancer
Sponsor: XBiotech USA, Inc.
Sample Size: Approximately 69 patients will be enrolled in the USA (at least 9 patients in the open label phase 1 portion and 60 patients in the randomized phase 2 portion)
Approximate Duration:
This trial will include 2 phases. The first portion will be a Phase I, open label, dose escalation study evaluating the safety, tolerability and establishing the Maximum Tolerated Dose (MTD) of XB2001 in at least nine patients with metastatic pancreatic adenocarcinoma who are receiving ONIVYDE + Leucovorin l + d racemic + 5-Fluorouracil chemotherapy treatment. The duration for each patient in the Phase I portion will be 14 days (1 treatment cycle) in which they will be given one intravenous dose of XB2001 prior to receiving ONIVYDE + Leucovorin l + d racemic + 5-Fluorouracil chemotherapy treatment and assessed for Dose Limited Toxicities (DLT). The Phase II portion will be implemented following the completion of the Phase I portion and declaration of the MTD. The duration of subject participation in the randomized, double-blind, placebo-controlled Phase II portion of the trial is approximately 28 weeks: including a screening period of up to 30 days, and 24-week treatment period. All study subjects can continue treatment with XB2001 in an open label extension, for as long as they are judged to be benefitting clinically and have had no unacceptable toxicities.
- Conditions
- Pancreatic Cancer
- Being tested
- Phase I: XB2001 250 mg, Phase I: XB2001 500 mg, Phase I: XB2001 1000 mg, Phase II: XB2001 1000 mg, Phase II: Placebo
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phase I: XB2001 250 mgBiological
Also called anti-IL-1⍺ True Human antibody
Subjects were administered one intravenous (IV) dose of XB2001 250 mg prior to receiving ONIVYDE 70 mg/m2 IV over 90 minutes, followed by leucovorin 400 mg/m2 IV over 30 minutes, followed by 5-Fluorouracil 2400 mg/m2 intravenously over 46 hours at each cycle.
Phase I: XB2001 500 mgBiological
Also called anti-IL-1⍺ True Human antibody
Subjects were administered one intravenous (IV) dose of XB2001 500 mg prior to receiving ONIVYDE 70 mg/m2 IV over 90 minutes, followed by leucovorin 400 mg/m2 IV over 30 minutes, followed by 5-Fluorouracil 2400 mg/m2 intravenously over 46 hours at each cycle.
Phase I: XB2001 1000 mgBiological
Also called anti-IL-1⍺ True Human antibody
Subjects were administered one intravenous (IV) dose of XB2001 1000 mg prior to receiving ONIVYDE 70 mg/m2 IV over 90 minutes, followed by leucovorin 400 mg/m2 IV over 30 minutes, followed by 5-Fluorouracil 2400 mg/m2 intravenously over 46 hours at each cycle.
Phase II: XB2001 1000 mgBiological
Also called anti-IL-1⍺ True Human antibody
Subjects were administered one intravenous (IV) dose of XB2001 1000 mg prior to receiving ONIVYDE 70 mg/m2 IV over 90 minutes, followed by leucovorin 400 mg/m2 IV over 30 minutes, followed by 5-Fluorouracil 2400 mg/m2 intravenously over 46 hours at each cycle.
Phase II: PlaceboBiological
Subjects were administered one intravenous (IV) dose of placebo 1000 mg prior to receiving ONIVYDE 70 mg/m2 IV over 90 minutes, followed by leucovorin 400 mg/m2 IV over 30 minutes, followed by 5-Fluorouracil 2400 mg/m2 intravenously over 46 hours at each cycle.
| Study group | Role | What they receive |
|---|---|---|
| Phase I: Dose Escalation Phase | Experimental | In Phase I (Dose escalation phase), 3 sequential dose levels were administered by participants; 250 mg (dose cohort 1), 500 mg (dose cohort 2), and 1000 mg (dose cohort 3), and traditional 3:3 design was used. Dose-escalation will continue if none of three subjects experience a dose-limiting toxicity (DLT).
After enrollment participants received two treatment cycles (a total of 28 days) in which they were given one intravenous (IV) dose of XB2001 prior to receiving ONIVYDE 70 mg/m2 IV over 90 minutes, followed by leucovorin 400 mg/m2 IV over 30 minutes, followed by 5-Fluorouracil 2400 mg/m2 intravenously over 46 hours at each cycle. Receives: Biological: Phase I: XB2001 250 mg; Biological: Phase I: XB2001 500 mg; Biological: Phase I: XB2001 1000 mg |
| Phase II: Dose Expansion Phase | Experimental | In Phase II (dose expansion phase), participants were randomized in 1:1 fashion and received:
1. XB2001 1000 mg combination with ONIVYDE, Leucovorin, and 5-Fluorouracil
2. Placebo 1000 mg in combination with ONIVYDE, Leucovorin, and 5-Fluorouracil Receives: Biological: Phase II: XB2001 1000 mg; Biological: Phase II: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Establish the Maximum Tolerated Dose (MTD) of XB2001 as Measured by Dose-Limiting Toxicity (DLT), in Combination With ONIVYDE + LV + 5-FU Chemotherapy Regimen in Patients With Advanced Pancreatic Cancer.
The primary objective of the Phase I portion is to identify the MTD of XB2001 when administered in combination with ONIVYDE + LV + 5-FU.
The MTD is defined as the highest dose level at which no more than one out of six subjects experience a DLT. If two or more subjects in a cohort of six experience a DLT, the MTD is considered exceeded, and the previous lower dose level will be identified as the MTD. If no DLTs are observed at the highest dose level studied, that dose will be used for Phase II.
A DLT is defined as any Grade 3-4 adverse event (per NCI CTCAE v5.0) occurring within the first 28 days that is deemed possibly related to the combination regimen, unless the toxicity is clearly attributable to a single non-XB2001 component. Specific DLT criteria include:
- Inability to deliver all scheduled doses during the 28-day window due to unexpected drug-related toxicity.
- Inability to deliver the intended dose of XB2001 due to drug-related toxicity.
Measured: 28 days (consisting of the first two 14-day treatment cycles or the formal DLT observation window).
Safety and Tolerability of XB2001 in Combination With ONIVYDE + LV + 5-FU
This endpoint evaluates the cumulative safety profile and patient tolerance of XB2001 when administered at the Maximum Tolerated Dose (MTD) or the maximum dose studied in Phase I, in combination with the ONIVYDE + LV + 5-FU regimen.
Safety is characterized by the total number of participants in each cohort who experienced one or more adverse events. For the purpose of this count, each participant is counted only once, regardless of the total number of individual adverse events experienced.
Measured: From post-infusion visit 1(week 0) through visit 13 (week 24), which is two weeks after the last infusion.
Secondary outcomes (9)
Progression Free Survival (PFS)
Progression free survival (PFS) was defined as the time from randomization to first progression based on RECIST v1.1 criteria or death from any cause, whichever occurred first. Subjects who had no baseline and post-baseline tumor assessment and no death, or no adequate post-baseline tumor assessment and no death were censored at the date of randomization. Subjects alive and without documented disease progression at the time of data analysis are censored at the date of the last adequate tumor assessment.
Measured: From baseline until the date of first documented disease progression or date of death (from any cause), whichever come first.
Overall Survival (OS)
OS was defined as the duration from the date of randomization until death irrespective of the cause. Subjects who were alive at the time of analysis were censored at the last known date alive. Subjects without any data after baseline were censored on the randomization day.
Measured: From baseline until death from any cause
Objective Response Rate (ORR)
Objective Response Rate (ORR) is defined as the proportion of subjects in the Phase II Population who achieved a Best Overall Response (BOR) of either Complete Response (CR) or Partial Response (PR), as defined by RECIST v1.1 criteria.
Measured: Analyses performed at Visit 5 (Week 8), Visit 9 (Week 16), and Visit 13 (Week 24). This outcome measure was reported for Visit 13.
Time to Treatment Failure(TTF)
TTF measures the time from randomization to discontinuation of treatment for any reason, including, but not limited to, disease progression, treatment-related toxicity, and/or death during study.
Measured: From baseline until treatment failure assessed up to Visit 13 (Week 24)
Number of Serious Adverse Events (SAEs)
This outcome measure calculates the total number of unique participants who reported serious adverse events (SAEs) in each group. An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
Measured: From post-infusion visit 1(week 0) through visit 13 (week 24), which is two weeks after the last infusion.
Incidence of Grade 3-4 Diarrhea
This measure tracks the overall burden of severe (Grade 3) or life-threatening (Grade 4) diarrhea as defined by the NCI CTCAE v5.0. Grade 3 events are severe enough to require medical intervention or significantly limit a person's ability to care for themselves, while Grade 4 events represent urgent, life-threatening clinical situations.
Measured: From post-infusion visit 1(week 0) through visit 13 (week 24), which is two weeks after the last infusion.
Duration of Hospitalization
This outcome measure calculates the sum of duration of hospitalizations during the study period in phase II population for both groups.
Measured: From post-infusion visit 1(week 0) through visit 13 (week 24), which is two weeks after the last infusion.
Plasma Concentration of Natrunix
Measurement of the concentration of Natrunix in plasma samples to evaluate the pharmacokinetic profile.
Due to reporting limitations on this portal, results from only one time point are reported here.
For Phase 1, samples were collected at V1 pre-dose, V1 post-dose, V2 pre-dose, V3 follow up. For phase 2, samples were collected at V1 pre-dose, V1 post-dose, V1 Day 4, V1 Day 7, V2 pre-dose, V3 pre-dose, V4 pre-dose, V6 pre-dose, V8 pre-dose, and V13 follow up. Placebo patients were tested at V1 post-dose only for verification.
Measured: Reported results Natrunix: Phase I: V1 post-dose collected at 30 min post-infusion at visit 1(Week 0), which represents Cmax of Cycle 1. Phase II: V6 pre-dose, at Visit 6 (Week 10), represents the trough of steady state concentration.
Number of Treatment Cycles
This measures the total number of cycles (total number of doses) received by subjects after randomization in each arm.
Measured: From randomization to end of study or study discontinuation for any reasons, up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start27 May 2021
- Primary completion26 Oct 2023
- Study completion10 Jun 2025
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 Pancreatic 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Subjects in phase II portion will be randomized on a 1:1 basis to XB2001 plus ONIVYDE + LV + 5-FU (Arm 1) or placebo plus ONIVYDE + LV + 5-FU (Arm 2).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- XBiotech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David J Park, Study chair, Providence St. Joseph Heritage
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04825288
- Sponsor's protocol ID
- 2020-PT049
- Acronym
- 1-BETTER
- Status last verified
- Jun 2026
- First submitted
- 24 Mar 2021
- Last updated
- 4 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Randomized, Double-blind, Placebo-controlled Trial (1-BETTER) Examining XB2001 (Anti-IL-1⍺ True Human Antibody) in Combination With ONIVYDE + 5-FU/LV (+Folinic Acid) in Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT04825288
- Acronym / sponsor ID
- 1-BETTER / 2020-PT049
- Conditions
- Pancreatic Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- XBiotech, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 May 2021 (actual)
- Primary completion
- 26 Oct 2023 (actual)
- Study completion
- 10 Jun 2025 (actual)
- First posted
- 1 Apr 2021 (actual)
- Results
- Posted 4 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial will include 2 portions (phase 1 and phase 2).
The first portion will be a Phase I, open label, dose escalation study to establish the maximum tolerated dose (MTD) of XB2001 as measured by Dose-Limiting Toxicity (DLT), in combination with ONIVYDE + LV + 5-FU chemotherapy regimen in patients with advanced pancreatic cancer and to determine the recommended dose for the subsequent Phase 2 study.
The phase 2 portion will be implemented with the maximum established tolerated dose (MTD) of XB2001. The target enrollment in the phase 2 portion is 60 patients which will be randomized on a 1:1 basis to XB2001 plus ONIVYDE + LV + 5-FU (Arm 1) or placebo plus ONIVYDE + LV + 5-FU (Arm 2).
Detailed description
Study Title: A Phase I/II randomized, double-blind, placebo-controlled trial (1-BETTER) examining XB2001 (anti-IL-1⍺ True Human antibody) in combination with ONIVYDE + 5-FU/LV (+folinic acid) in advanced pancreatic cancer
Sponsor: XBiotech USA, Inc.
Sample Size: Approximately 69 patients will be enrolled in the USA (at least 9 patients in the open label phase 1 portion and 60 patients in the randomized phase 2 portion)
Approximate Duration:
This trial will include 2 phases. The first portion will be a Phase I, open label, dose escalation study evaluating the safety, tolerability and establishing the Maximum Tolerated Dose (MTD) of XB2001 in at least nine patients with metastatic pancreatic adenocarcinoma who are receiving ONIVYDE + Leucovorin l + d racemic + 5-Fluorouracil chemotherapy treatment. The duration for each patient in the Phase I portion will be 14 days (1 treatment cycle) in which they will be given one intravenous dose of XB2001 prior to receiving ONIVYDE + Leucovorin l + d racemic + 5-Fluorouracil chemotherapy treatment and assessed for Dose Limited Toxicities (DLT). The Phase II portion will be implemented following the completion of the Phase I portion and declaration of the MTD. The duration of subject participation in the randomized, double-blind, placebo-controlled Phase II portion of the trial is approximately 28 weeks: including a screening period of up to 30 days, and 24-week treatment period. All study subjects can continue treatment with XB2001 in an open label extension, for as long as they are judged to be benefitting clinically and have had no unacceptable toxicities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects in phase II portion will be randomized on a 1:1 basis to XB2001 plus ONIVYDE + LV + 5-FU (Arm 1) or placebo plus ONIVYDE + LV + 5-FU (Arm 2).
| Arm | Type | Receives |
|---|---|---|
| Phase I: Dose Escalation Phase | Experimental | Biological: Phase I: XB2001 250 mg, Biological: Phase I: XB2001 500 mg, Biological: Phase I: XB2001 1000 mgIn Phase I (Dose escalation phase), 3 sequential dose levels were administered by participants; 250 mg (dose cohort 1), 500 mg (dose cohort 2), and 1000 mg (dose cohort 3), and traditional 3:3 design was used. Dose-escalation will continue if none of three subjects experience a dose-limiting toxicity (DLT). After enrollment participants received two treatment cycles (a total of 28 days) in which they were given one intravenous (IV) dose of XB2001 prior to receiving ONIVYDE 70 mg/m2 IV over 90 minutes, followed by leucovorin 400 mg/m2 IV over 30 minutes, followed by 5-Fluorouracil 2400 mg/m2 intravenously over 46 hours at each cycle. |
| Phase II: Dose Expansion Phase | Experimental | Biological: Phase II: XB2001 1000 mg, Biological: Phase II: PlaceboIn Phase II (dose expansion phase), participants were randomized in 1:1 fashion and received: 1. XB2001 1000 mg combination with ONIVYDE, Leucovorin, and 5-Fluorouracil 2. Placebo 1000 mg in combination with ONIVYDE, Leucovorin, and 5-Fluorouracil |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically or cytologically confirmed pancreatic adenocarcinoma of exocrine pancreas that is metastatic, unresectable, or recurrent
- At least one measurable lesion according to Response Evaluation Criteria in Solid Tumor V1.1
- Documented disease progression after one prior gemcitabine-based therapy OR one FOLFIRINOX and gemcitabine combination therapy
- Eastern Cooperative Oncology Group (ECOG) performance of 0 or 1 or Karnofsky performance status (KPS) ≥ 70
- Adequate hepatic, renal and bone marrow function
Key exclusion criteria (7 listed)
- Clinically significant decrease in performance status (medical records) within 2 weeks of intended first dose administration
- Clinically significant GI disorders
- Severe arterial thromboembolic events less than 6 months before inclusion
- Prior Whole Brain Radiation Therapy (WBRT)
- Evidence of brain metastases
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 |
|---|---|---|
| Phase I: XB2001 250 mgAlso: anti-IL-1⍺ True Human antibodySubjects were administered one intravenous (IV) dose of XB2001 250 mg prior to receiving ONIVYDE 70 mg/m2 IV over 90 minutes, followed by leucovorin 400 mg/m2 IV over 30 minutes, followed by 5-Fluorouracil 2400 mg/m2 intravenously over 46 hours at each cycle. | Biological | Phase I: Dose Escalation Phase |
| Phase I: XB2001 500 mgAlso: anti-IL-1⍺ True Human antibodySubjects were administered one intravenous (IV) dose of XB2001 500 mg prior to receiving ONIVYDE 70 mg/m2 IV over 90 minutes, followed by leucovorin 400 mg/m2 IV over 30 minutes, followed by 5-Fluorouracil 2400 mg/m2 intravenously over 46 hours at each cycle. | Biological | Phase I: Dose Escalation Phase |
| Phase I: XB2001 1000 mgAlso: anti-IL-1⍺ True Human antibodySubjects were administered one intravenous (IV) dose of XB2001 1000 mg prior to receiving ONIVYDE 70 mg/m2 IV over 90 minutes, followed by leucovorin 400 mg/m2 IV over 30 minutes, followed by 5-Fluorouracil 2400 mg/m2 intravenously over 46 hours at each cycle. | Biological | Phase I: Dose Escalation Phase |
| Phase II: XB2001 1000 mgAlso: anti-IL-1⍺ True Human antibodySubjects were administered one intravenous (IV) dose of XB2001 1000 mg prior to receiving ONIVYDE 70 mg/m2 IV over 90 minutes, followed by leucovorin 400 mg/m2 IV over 30 minutes, followed by 5-Fluorouracil 2400 mg/m2 intravenously over 46 hours at each cycle. | Biological | Phase II: Dose Expansion Phase |
| Phase II: PlaceboSubjects were administered one intravenous (IV) dose of placebo 1000 mg prior to receiving ONIVYDE 70 mg/m2 IV over 90 minutes, followed by leucovorin 400 mg/m2 IV over 30 minutes, followed by 5-Fluorouracil 2400 mg/m2 intravenously over 46 hours at each cycle. | Biological | Phase II: Dose Expansion Phase |
Primary outcome
To Establish the Maximum Tolerated Dose (MTD) of XB2001 as Measured by Dose-Limiting Toxicity (DLT), in Combination With ONIVYDE + LV + 5-FU Chemotherapy Regimen in Patients With Advanced Pancreatic Cancer.
Time frame: 28 days (consisting of the first two 14-day treatment cycles or the formal DLT observation window).
The primary objective of the Phase I portion is to identify the MTD of XB2001 when administered in combination with ONIVYDE + LV + 5-FU. The MTD is defined as the highest dose level at which no more than one out of six subjects experience a DLT. If two or more subjects in a cohort of six experience a DLT, the MTD is considered exceeded, and the previous lower dose level will be identified as the MTD. If no DLTs are observed at the highest dose level studied, that dose will be used for Phase II. A DLT is defined as any Grade 3-4 adverse event (per NCI CTCAE v5.0) occurring within the first 28 days that is deemed possibly related to the combination regimen, unless the toxicity is clearly attributable to a single non-XB2001 component. Specific DLT criteria include: 1. Inability to deliver all scheduled doses during the 28-day window due to unexpected drug-related toxicity. 2. Inability to deliver the intended dose of XB2001 due to drug-related toxicity.
Safety and Tolerability of XB2001 in Combination With ONIVYDE + LV + 5-FU
Time frame: From post-infusion visit 1(week 0) through visit 13 (week 24), which is two weeks after the last infusion.
This endpoint evaluates the cumulative safety profile and patient tolerance of XB2001 when administered at the Maximum Tolerated Dose (MTD) or the maximum dose studied in Phase I, in combination with the ONIVYDE + LV + 5-FU regimen. Safety is characterized by the total number of participants in each cohort who experienced one or more adverse events. For the purpose of this count, each participant is counted only once, regardless of the total number of individual adverse events experienced.
9 secondary outcomes
Progression Free Survival (PFS)
Time frame: From baseline until the date of first documented disease progression or date of death (from any cause), whichever come first.
Overall Survival (OS)
Time frame: From baseline until death from any cause
Objective Response Rate (ORR)
Time frame: Analyses performed at Visit 5 (Week 8), Visit 9 (Week 16), and Visit 13 (Week 24). This outcome measure was reported for Visit 13.
Time to Treatment Failure(TTF)
Time frame: From baseline until treatment failure assessed up to Visit 13 (Week 24)
Number of Serious Adverse Events (SAEs)
Time frame: From post-infusion visit 1(week 0) through visit 13 (week 24), which is two weeks after the last infusion.
Incidence of Grade 3-4 Diarrhea
Time frame: From post-infusion visit 1(week 0) through visit 13 (week 24), which is two weeks after the last infusion.
Duration of Hospitalization
Time frame: From post-infusion visit 1(week 0) through visit 13 (week 24), which is two weeks after the last infusion.
Plasma Concentration of Natrunix
Time frame: Reported results Natrunix: Phase I: V1 post-dose collected at 30 min post-infusion at visit 1(Week 0), which represents Cmax of Cycle 1. Phase II: V6 pre-dose, at Visit 6 (Week 10), represents the trough of steady state concentration.
Number of Treatment Cycles
Time frame: From randomization to end of study or study discontinuation for any reasons, up to 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. No plan to share
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Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
Pancreatic Carcinoma, Pancreatic Neoplasm
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.
David J Park study chair
Providence St. Joseph Heritage
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Phase I: XB2001 250 mg, Phase I: XB2001 500 mg and Phase I: XB2001 1000 mg in people with Pancreatic Cancer, run by XBiotech, Inc. at 30 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 5 inclusion and 7 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 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 4 Aug 2026). 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?
To Establish the Maximum Tolerated Dose (MTD) of XB2001 as Measured by Dose-Limiting Toxicity (DLT), in Combination With ONIVYDE + LV + 5-FU Chemotherapy Regimen in Patients With Advanced Pancreatic Cancer. (time frame: 28 days (consisting of the first two 14-day treatment cycles or the formal DLT observation window).). 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?
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 4 Aug 2026.