76 Participants Needed

XB2001 + Chemotherapy for Pancreatic Cancer

(1-BETTER Trial)

Recruiting at 28 trial locations
HP
NG
Overseen ByNorma Gonzalez

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?

Research shows that combining nab-paclitaxel with gemcitabine improves survival in patients with advanced pancreatic cancer compared to using gemcitabine alone. This suggests that combination therapies, like XB2001 with chemotherapy, might also be effective.12345

What safety data exists for XB2001 + chemotherapy in humans?

The safety of nab-paclitaxel plus gemcitabine, which is part of the chemotherapy regimen, has been evaluated in several studies. It showed an acceptable safety profile in patients with advanced solid tumors, including pancreatic cancer, and was generally well-tolerated in real-life practice.12678

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

DJ

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.
See 2 more

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.
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks
1 visit (in-person)

Phase I Treatment

Open label, dose escalation study to establish the maximum tolerated dose (MTD) of XB2001 in combination with ONIVYDE + LV + 5-FU

2 weeks
1 visit (in-person)

Phase II Treatment

Randomized, double-blind, placebo-controlled study with XB2001 or placebo in combination with ONIVYDE + LV + 5-FU

24 weeks
12 visits (in-person, every 2 weeks)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
2 visits (in-person)

Open-label Extension

Participants may continue treatment with XB2001 as long as they are benefitting clinically and have no unacceptable toxicities

Long-term

Treatment Details

Interventions

  • XB2001
Trial Overview The 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).

Find a Clinic Near You

Who Is Running the Clinical Trial?

XBiotech, Inc.

Lead Sponsor

Trials
8
Recruited
740+

Findings from Research

In a study of 41 patients with advanced pancreatic adenocarcinoma, the combination of Nab-paclitaxel and gemcitabine showed an overall response rate of 36.6%, with a median progression-free survival of 6.7 months and median overall survival of 10 months, indicating its efficacy as a first-line treatment.
The treatment was well tolerated, with no grade 4 toxicities reported; the most common grade 3 toxicities included neutropenia and thrombocytopenia, suggesting a favorable safety profile for this combination therapy.
NAB-paclitaxel and gemcitabine in metastatic pancreatic ductal adenocarcinoma (PDAC): from clinical trials to clinical practice.De Vita, F., Ventriglia, J., Febbraro, A., et al.[2023]
The introduction of nab-paclitaxel combined with gemcitabine has significantly improved survival rates for patients with advanced pancreatic cancer, as demonstrated in the MPACT study from 2013.
Prior to 2011, treatment options for pancreatic cancer were limited, primarily relying on gemcitabine, but the Phase III results of FOLFIRINOX and subsequent studies have expanded the therapeutic options available for oncologists.
Nab-paclitaxel and gemcitabine for the treatment of patients with metastatic pancreatic cancer.Borazanci, E., Von Hoff, DD.[2022]
Itacitinib, a selective JAK1 inhibitor, combined with nab-paclitaxel and gemcitabine, showed an acceptable safety profile and clinical activity in patients with advanced solid tumors, including pancreatic cancer, with a 24% overall response rate across various doses.
The study indicated that while itacitinib was tolerated at lower doses, treatment-related toxicities such as neutropenia and fatigue were common, leading to dose adjustments; however, the study was terminated early due to negative results from a related phase III trial.
A Phase Ib/II Study of the JAK1 Inhibitor, Itacitinib, plus nab-Paclitaxel and Gemcitabine in Advanced Solid Tumors.Beatty, GL., Shahda, S., Beck, T., et al.[2022]

References

Prognostic factors for survival with nab-paclitaxel plus gemcitabine in metastatic pancreatic cancer in real-life practice: the ANICE-PaC study. [2022]
NAB-paclitaxel and gemcitabine in metastatic pancreatic ductal adenocarcinoma (PDAC): from clinical trials to clinical practice. [2023]
Nab-paclitaxel and gemcitabine for the treatment of patients with metastatic pancreatic cancer. [2022]
Comparison of efficacy and toxicity of FOLFIRINOX and gemcitabine with nab-paclitaxel in unresectable pancreatic cancer. [2022]
Stromal disrupting effects of nab-paclitaxel in pancreatic cancer. [2022]
A Phase Ib/II Study of the JAK1 Inhibitor, Itacitinib, plus nab-Paclitaxel and Gemcitabine in Advanced Solid Tumors. [2022]
Low-dose nab-paclitaxel-based combination chemotherapy in heavily pretreated pancreatic cancer patients. [2020]
A Phase I/II Open-Label Multicenter Single-Arm Study of FABLOx (Metronomic 5-Fluorouracil Plus nab-Paclitaxel, Bevacizumab, Leucovorin, and Oxaliplatin) in Patients with Metastatic Pancreatic Cancer. [2023]
Response and Survival Associated With First-line FOLFIRINOX vs Gemcitabine and nab-Paclitaxel Chemotherapy for Localized Pancreatic Ductal Adenocarcinoma. [2022]
Combination of gemcitabine, nab-paclitaxel, and S-1(GAS) as the first-line treatment for patients with locally advanced or advanced pancreatic ductal adenocarcinoma: study protocol for an open-label, single-arm phase I study. [2022]
Intensified Neoadjuvant Chemotherapy with Nab-Paclitaxel plus Gemcitabine Followed by FOLFIRINOX in a Patient with Locally Advanced Unresectable Pancreatic Cancer. [2020]
First-line nab-paclitaxel and gemcitabine in patients with metastatic pancreatic cancer from routine clinical practice. [2022]
Feasibility of Combination Therapy with Nab-paclitaxel Plus Gemcitabine in Patients with Recurrent Pancreatic Cancer. [2022]
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