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

Recruiting in Palo Alto (17 mi)

+28 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: XBiotech, Inc.

Trial Summary

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

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

You have at least one spot that can be measured according to specific guidelines for evaluating tumors.

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

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Exclusion Criteria

I have not had a severe blood clot in my arteries in the last 6 months.

I haven't taken strong CYP3A4 or UGT1A1 inhibitors in the last 14 days.

My cancer has spread to my brain.

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Treatment Details

Interventions

XB2001 (Virus Therapy)

Trial OverviewThe 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.

Participant Groups

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).