XB2001 + Chemotherapy for Pancreatic Cancer
(1-BETTER Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial requires that you stop using strong CYP3A4 inducers or inhibitors and UGT1A1 inhibitors at least 14 days before starting the trial. Other medications are not specifically mentioned, so it's best to discuss with the trial team.
What data supports the effectiveness of the drug XB2001 for pancreatic cancer?
What safety data exists for XB2001 + chemotherapy in humans?
What makes the drug XB2001 unique for treating pancreatic cancer?
The drug XB2001 is unique for treating pancreatic cancer because it is being tested in combination with chemotherapy, potentially offering a new approach compared to existing treatments like FOLFIRINOX or gemcitabine with nab-paclitaxel, which are standard regimens. This combination could provide a novel mechanism or improved effectiveness, although specific details about XB2001's action or benefits are not provided in the available research.910111213
What is the purpose of this trial?
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).
Research Team
David J Park
Principal Investigator
Providence St. Joseph Heritage
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Phase I Treatment
Open label, dose escalation study to establish the maximum tolerated dose (MTD) of XB2001 in combination with ONIVYDE + LV + 5-FU
Phase II Treatment
Randomized, double-blind, placebo-controlled study with XB2001 or placebo in combination with ONIVYDE + LV + 5-FU
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label Extension
Participants may continue treatment with XB2001 as long as they are benefitting clinically and have no unacceptable toxicities
Treatment Details
Interventions
- XB2001
Find a Clinic Near You
Who Is Running the Clinical Trial?
XBiotech, Inc.
Lead Sponsor