36 Participants Needed

XER-001 for Pancreatic Cancer

(XER-001 Trial)

Recruiting at 1 trial location
RF
JJ
Overseen ByJeanne Jones
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called XER-001, a potential drug for people with pancreatic cancer. Researchers aim to determine the safety of XER-001, its effectiveness, and the optimal dose for future studies. The trial targets individuals diagnosed with pancreatic cancer that cannot be surgically removed and who have already undergone other first-line treatments. Participants should not have cancer that has metastasized and must be able to undergo certain procedures, such as SBRT (a type of targeted radiation therapy). As a Phase 1 trial, this research seeks to understand how XER-001 works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that you should not be using hepatotoxic drugs (drugs that can harm the liver) unless a washout period (time without taking certain medications) has been completed. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that XER-001 is likely to be safe for humans?

Research has shown that XER-001 underwent safety testing in earlier studies. These studies assessed the treatment's safety and tolerability for patients, testing various doses to determine the most suitable for future research. So far, patients have generally tolerated XER-001 well, with no reports of severe side effects. Researchers continue to monitor for any issues as doses increase. As an early-stage study, the focus remains on understanding the body's reaction to the treatment and identifying possible side effects. Much remains to be learned about its safety in larger populations.12345

Why do researchers think this study treatment might be promising?

XER-001 is unique because it targets pancreatic cancer differently than traditional treatments like chemotherapy or radiation. Unlike these standard options, which often attack both cancerous and healthy cells, XER-001 is designed to specifically focus on cancer cells, potentially reducing side effects. Researchers are excited about XER-001 because of its novel mechanism that might improve targeted action against pancreatic tumors, offering a promising new direction for treatment.

What evidence suggests that XER-001 might be an effective treatment for pancreatic cancer?

Research is investigating XER-001 as a potential treatment for pancreatic cancer. This trial tests XER-001 at increasing dose levels to assess its safety and tolerability. Although limited information from human studies exists, the trial aims to evaluate the treatment's safety and patient tolerance. Detailed reports on XER-001's effectiveness are not yet available, but there is hope it could address gaps in current treatments. Existing treatments, such as irinotecan in the FOLFIRINOX regimen, offer some benefit, but new options are necessary due to the aggressive nature of pancreatic cancer. Early studies like this one seek to determine the optimal dose and explore potential patient benefits in the future.16789

Are You a Good Fit for This Trial?

This trial is for adults over 18 with locally advanced pancreatic cancer that can't be removed by surgery due to its position or patient's health. Candidates must have finished first-line chemotherapy, have no distant metastases, and be able to undergo radiotherapy with specific motion management techniques.

Inclusion Criteria

My pancreatic cancer is advanced and cannot be surgically removed.
My condition is considered operable but I can't undergo surgery due to other health issues.
I chose not to have surgery and am eligible for SBRT for my condition.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Evaluation of safety, tolerability, and pharmacokinetics of XER-001 with SBRT in patients with LAPC

18 months

Dose Expansion

Evaluation of safety and efficacy of combination SBRT and XER-001 with liberalized duodenal radiation dose constraints

22 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • XER-001

Trial Overview

The study tests the safety and effectiveness of XER-001 (Amifostine) delivered nasoduodenally in combination with stereotactic body radiotherapy (SBRT). It aims to find the best dose for future research on patients who are not candidates for surgical treatment.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: XER-001 at increasing dose levelsExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Xerient Pharma

Lead Sponsor

Citations

A Phase 1 Study to Evaluate Safety and Efficacy of XER ...

The primary objective of the phase 1 component of the study is to evaluate the safety, tolerability, and PK of nasoduodenal administration ...

Real World Data for Pancreatic Adenocarcinoma from a ... - PMC

For the entire cohort, 1-year mortality rate after diagnosis was 77.81%. Chemotherapy was associated with better survival for both operated (HR ...

255P Real-world outcomes of long-term survivors ...

NALLONG study explores a real-world cohort of mPDAC pts who survived ≥1 year after initiation of nal-IRI therapy.

A Review of Recent Real-World Evidence Data in ...

Although conventional irinotecan is effective against pancreatic cancer and therefore is still used as part of the FOLFIRINOX regimen, its use may be limited by ...

Treatment patterns and outcomes in pancreatic cancer ...

This was a retrospective database study examining treatment patterns and outcomes among pancreatic adenocarcinoma patients with locally advanced ...

A Phase 1/2a, Open Label, Dose-Escalation Study to Evaluate ...

The purpose of this study is to assess the safety, tolerability and efficacy of XER-001 and identify a best dose for future studies.

Clinical Trial: A Phase 1 Study to Evaluate Safety and ...

Brief Summary: The purpose of this study is to assess the safety, tolerability and efficacy of XER-001 and identify a best dose for future ...

A phase I study of the safety and activity of K-001 in patients ...

The 5-year survival rate of PDAC is less than 7% (the data has not fluctuated significantly in the past 20 years), and it has been estimated that PDAC may ...

A Phase 1 Study to Evaluate Safety and Efficacy of XER-001 ...

A Phase 1 Study to Evaluate Safety and Efficacy of XER-001 (Amifostine for Nasoduodenal Delivery) in Combination With Sterotactic Body ...