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Virus Therapy

XB2001 + Chemotherapy for Pancreatic Cancer (1-BETTER Trial)

Phase 1 & 2

Waitlist Available

Research Sponsored by XBiotech, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically or cytologically confirmed pancreatic adenocarcinoma of exocrine pancreas that is metastatic, unresectable, or recurrent

Documented disease progression after one prior gemcitabine-based therapy OR one FOLFIRINOX and gemcitabine combination therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to weeks 4, 8, 12, 16, 20 and 24

Awards & highlights

1-BETTER Trial Summary

This trial will have two parts: a phase 1 portion to establish the maximum tolerated dose, and a phase 2 portion to study the effect of the drug on pancreatic cancer.

Who is the study for?

This trial is for adults with advanced pancreatic cancer who've had disease progression after one prior gemcitabine-based therapy or a FOLFIRINOX and gemcitabine combo. They must have at least one measurable tumor, be relatively fit (ECOG 0-1 or KPS ≥70), and their major organs need to function well. Exclusions include recent severe heart issues, brain metastases, certain GI disorders, and use of strong CYP3A4/UGT1A1 drugs recently.Check my eligibility

What is being tested?

The study tests XB2001 combined with ONIVYDE + LV + 5-FU chemotherapy in two phases: Phase 1 finds the safest high dose (MTD) without serious side effects; Phase 2 uses this MTD in half the patients while the other half receive a placebo plus standard chemo. Patients are randomly assigned to these groups.See study design

What are the potential side effects?

Possible side effects may include reactions related to immune activation by XB2001 such as inflammation in various organs, infusion-related symptoms like fever or chills, fatigue from treatment burden on the body's resources, digestive disturbances due to chemotherapy impact on gut lining cells, blood cell count changes affecting immunity and clotting.

1-BETTER Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My pancreatic cancer is confirmed and cannot be removed by surgery.

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My cancer progressed after treatment with gemcitabine or FOLFIRINOX and gemcitabine.

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I am mostly active and can care for myself.

1-BETTER Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to weeks 4, 8, 12, 16, 20 and 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to weeks 4, 8, 12, 16, 20 and 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to weeks 4, 8, 12, 16, 20 and 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v5.0

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.

Secondary outcome measures

Change in (CD14+CD16+IL-1⍺+) triple positive tumor associated monocytes in peripheral blood

Duration of hospitalizations

Incidence of Grade 3-4 Diarrhea

+9 more

Other outcome measures

Cardiotoxicity measured by the number of required ECGs and cardiotoxicity related events summarized by treatment arm and compared over time

Results of a symptom questionnaire will be summarized by treatment arm at various post-infusion time points and compared over time

1-BETTER Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Arm 1Active Control1 Intervention

XB2001 + ONIVYDE + 5-FU + LV combination therapy administered for 12 cycles of treatment • Arm 1 Treatment Cycle: Patients randomized to this arm will receive the following treatments every 2 weeks: XB2001 MTD as an intravenous infusion over up to 60 minutes, followed by ONIVYDE 70 mg/m2 intravenously over 90 minutes, followed by leucovorin l + d racemic 400 mg/m2 intravenously over 30 minutes, followed by 5-Fluorouracil 2400mg/m2 intravenously over 46 hours. Therapy will be administered every 2 weeks (2 weeks = 1 cycle).

Group II: Arm 2Placebo Group1 Intervention

Placebo + ONIVYDE + 5-FU + LV combination therapy administered for 12 cycles of treatment • Arm 2 Treatment Cycle: Patients randomized to this arm will receive the following treatments every 2 weeks: Placebo as an intravenous infusion over up to 60 minutes, followed by ONIVYDE 70 mg/m2 intravenously over 90 minutes, followed by leucovorin l + d racemic 400 mg/m2 intravenously over 30 minutes, followed by 5-fluorouracil 2400 mg/m2 intravenously over 46 hours. Therapy will be administered every 2 weeks (2 weeks = 1 cycle).

0 / 3Eligibility criteria met

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Who is running the clinical trial?

XBiotech, Inc.Lead Sponsor

5 Previous Clinical Trials

460 Total Patients Enrolled

Benjamin MusherStudy ChairBaylor College of Medicine

Shubham PantStudy ChairThe University of Texas MD Anderson Cancer Center

3 Previous Clinical Trials

62 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the projected outcomes of this clinical experiment?

"This trial's primary outcome, to be evaluated over a period of 44 days, is the Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v5.0. Secondary endpoints include Overall Survival (OS), Duration of Hospitalizations for Phase 2 Participants only, and Objective Response Rate which will measure patients' best overall response according to RECIST 1.1 standards."

Answered by AI

How many participants are taking part in this medical experiment?

"Affirmative, the entry on clinicaltrials.gov declares that this experiment is currently recruiting participants. First advertised on May 27th 2021 and last revised on May 5th 2022, 69 volunteers are required from 3 distinct medical venues."

Answered by AI

Are there any opportunities to join this trial currently available?

"Affirmative. Records available on clinicaltrials.gov demonstrate that this medical research project, which was initially published on May 27th 2021, is actively enrolling patients. 69 individuals are needed from 3 distinct sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

XB2001 in Combination With ONIVYDE + 5-FU/LV (+Folinic Acid) in Advanced Pancreatic Cancer

2021. "XB2001 in Combination With ONIVYDE + 5-FU/LV (+Folinic Acid) in Advanced Pancreatic Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04825288.