XB2001 in Combination With ONIVYDE + 5-FU/LV (+Folinic Acid) in Advanced Pancreatic Cancer
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).
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
Adults
Not Available
Not Available
Cardin, Dana
National
Vanderbilt University
01-18-2022
Treatment
VICCGIP2146
NCT04825288
Eligibility
18 Years
BOTH
NO
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.
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.
