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XER-001 with Radiation for Locally Advanced Pancreatic Cancer

This study is testing a drug called XER-001 (Amifostine for nasoduodenal delivery) alongside stereotactic body radiotherapy (SBRT) for people with locally advanced pancreatic cancer. The main goal is to see how safe XER-001 is, how well people tolerate it, and to find the best dose for future studies. Researchers will also look at how effective this combination treatment is. You may be able to join if you have pancreatic adenocarcinoma that is locally advanced or can't be removed by surgery. This study aims to enroll 36 participants, but its current recruitment status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 36 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety will be assessed for up to 40 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07157033

A Phase 1 Study to Evaluate Safety and Efficacy of XER-001 (Amifostine for Nasoduodenal Delivery) in Combination With Sterotactic Body Radiotherapy for Treatment in Patients With Locally Advanced Pancreatic Cancer.

Recruiting
PHASE1Ages 18+InterventionalTreatment
Xerient Pharma
~36 participants
Updated 2026-08-17 on ClinicalTrials.gov
What's tested:XER-001

At a glance

Recruiting sites
5 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety Assessments [Dose Escalation]
Measured over 18 Months
+5 more outcomes measured

Conditions

Locally Advanced Pancreatic Adenocarcinoma
Locally Advanced Pancreas Cancer
Locally Advanced Pancreatic Ductal Adenocarcinoma

Explore related trials

Pancreatic Carcinoma

Where it's being run

5 sites across 4 states
California2
Michigan1
New Mexico1
Texas1

Who to contact

Robbin Frnka
[email protected]
2142055746
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Postmenopausal (no menses in greater than or equal to 12 consecutive months or validated by follicle stimulating hormone \[FSH\] levels.
History of hysterectomy or bilateral salpingo-oophorectomy
Ovarian failure (FSH and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy)
History of bilateral tubal ligation or another surgical sterilization procedure 16. Approved methods of birth control are as follows: hormonal contraception (I.e. birth control pills, injection, implant, transdermal patch, vaginal ring), intrauterine device (IUD), tubal ligation or hysterectomy, subject/partner post vasectomy, implantable or injectable contraceptives, and condoms with spermacide. Not engaging in sexual activity through six months following the last (fifth) day of radiotherapy on this study is an acceptable practice; however periodic abstinence, the rhytm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.

What this trial measures

  • Safety Assessments [Dose Escalation]18 Months

    Incidence of Dose Limiting Toxicities (DLTs) in DLT-evaluable subjects

  • Safety Assessments [Dose Escalation]18 Months

    Identify the maximum tolerated dose and the RP2D

  • Safety Assessments [Dose escalation and Dose Expansion]40 months

    Number of participants with Serious Adverse Events (SAEs) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0

  • Safety Assessments [Dose Escalation and Dose Expansion]40 Months

    Number of participants with Treatment-related Adverse Events (AEs) graded per NCI-CTCAE version 5.0

  • Safety Assessments [Dose Escalation and Dose Expansion]40 Months

    Number of participants with Treatment-Emergent AEs (TEAEs) graded per NCI-CTCAE version 5.0

  • Safety Assessments [Dose Escalation and Dose Expansion]40 Months

    Gastrointestinal toxicity related to SBRT and LAPC