Study on XB2001 with ONIVYDE and 5-FU/LV for Advanced Pancreatic Cancer

Sponsor: XBiotech, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04825288

Provider View

This clinical trial is testing a new treatment combination for advanced pancreatic cancer, involving the drug XB2001 with ONIVYDE and 5-FU/LV. The study aims to find the safest dose and see if this combination is more effective than the standard treatment.

Patient Parameters

Program Overview

This study is divided into two parts. The first part (Phase I) will test different doses of XB2001 to find the highest dose that patients can tolerate when combined with ONIVYDE and 5-FU/LV. The second part (Phase II) will use the best dose from Phase I to compare the effects of XB2001 with a placebo, both combined with ONIVYDE and 5-FU/LV, in patients with advanced pancreatic cancer. The goal is to see if adding XB2001 improves treatment outcomes.

Description

This clinical trial, called 1-BETTER, is sponsored by XBiotech USA, Inc. and led by Dr. David Park. It involves about 69 patients in the USA. The trial has two phases:

  • Phase I: This part is open-label, meaning all participants know what treatment they are receiving. It will test increasing doses of XB2001 to find the maximum dose that patients can handle without severe side effects. At least nine patients with advanced pancreatic cancer will participate, receiving one dose of XB2001 before their standard chemotherapy treatment. This phase lasts 14 days.

  • Phase II: This part is randomized and double-blind, meaning neither the participants nor the researchers know who is receiving XB2001 or a placebo. Sixty patients will be divided into two groups: one receiving XB2001 with ONIVYDE and 5-FU/LV, and the other receiving a placebo with the same chemotherapy. This phase lasts about 28 weeks, including a screening period and a 24-week treatment period. Patients who benefit from XB2001 can continue receiving it in an open-label extension as long as it helps them and they do not experience unacceptable side effects.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with advanced pancreatic cancer that cannot be removed by surgery or has returned.
  • Have at least one tumor that can be measured by scans.
  • Cancer has worsened after previous treatment with gemcitabine or a combination of FOLFIRINOX and gemcitabine.
  • Be in good overall health, with a performance status score of 0 or 1, or a Karnofsky score of 70 or higher.
  • Have adequate liver, kidney, and bone marrow function.

Exclusion Criteria

  • Significant decline in health within two weeks before starting the study.
  • Serious digestive system disorders.
  • Severe heart or blood vessel problems within six months before joining the study.
  • Previous whole brain radiation therapy or evidence of cancer spread to the brain.
  • Severe heart failure or uncontrolled high blood pressure.
  • Use of certain medications that affect liver enzymes within 14 days before starting the study.

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