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Clinical Trials Search at Vanderbilt-Ingram Cancer Center

XB2001 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).
Pancreatic, Phase I
Phase I/II
Not Available
Not Available
Cardin, Dana
Vanderbilt University


18 Years
Inclusion Criteria:

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

Exclusion Criteria:

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.

To learn more about any of our clinical
trials, call 615-936-8422.