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Locally Advanced Pancreatic AdenocarcinomaPhase 1/2XER-001NCT07157033

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.

A Phase 1/2 study testing XER-001 in people with Locally Advanced Pancreatic Adenocarcinoma and Locally Advanced Pancreas Cancer, run by Xerient Pharma at 5 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
What is being tested?
XER-001
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
5 sitesUnited States
Study dates
1 Jan 2026to 31 Jul 2034
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Cytologic or biopsy confirmed adenocarcinoma of the pancreas
  • Disease deemed amenable to definitive treatment with SBRT by being:
  • Locally-advanced and/or technically unresectable, as determined by a specialist pancreaticobiliary surgeon and as part of a multidisciplinary team review including of multiphase cross-sectional imaging, demonstrating: i. Greater than 180-degree tumor involvement of the superior mesenteric artery (SMA) ii. Greater than 180-degree tumor involvement of the celiac axis including major branches of the celiac axis that would render the tumor unresectable (e.g. common hepatic artery) iii. Tumor involvement of the first branch of the SMA that is not surgically reconstructible iv. Long segment involvement of the superior mesenteric vein/portal vein/hepatic artery that is not amenable to surgical reconstructible.
  • Potentially resectable anatomically but deemed not a surgical candidate after multidisciplinary review (such as unresectable due to comorbid conditions that render.
  • the risks of surgery prohibitive)
  • Potentially resectable but the patient elects to refuse surgery and prefers to pursue SBRT, and disease is deemed eligible for SBRT
Show all 34Show fewer
  • Primary tumor involvement abutment of the bowel is allowed, however bowel infiltration or invasion (identified endoscopically or by contrast enhanced imaging) is not allowed.
  • No distant metastatic disease either prior to or following induction systemic therapy
  • Completion of medically indicated first line systemic therapy, which may include but is not limited to regimens such as FOLFIRNOX, gemcitabine/abraxane, and similar regimens
  • Patients must be able to understand and comply with any treatment related procedures for SBRT. including breath-hold techniques or tolerance of compression belt, or other motion management strategies for SBRT delivery.
  • Age 18 years or older
  • Eastern Cooperative Group (ECOG) performance status 0, 1, or 2
  • Adequate hematologic function as indicated by:
  • Absolute neutrophil counts >/= 1500/mm3
  • Hemaglobin >/= 8.0 g/dL
  • Plor current use of hepato atelet count >/= 75,000/mm3
  • No known liver disease or hepatic impairment, as well as no recent or current use of hepatotoxic drugs or substances that could compromise liver function unless a washout period has been completed. Adequate liver function as indicated by:
  • Total bilirubin </= 1.5x upper limits of normal (per institutional laboratory reference standard)
  • Aspartate aminotransferase (AST) and alanine aminotranferase (ALT) </= 2.5 upper limits of normal (per institutional reference standard)
  • Baseline serum calcium level >/= 8.4 mg/dL
  • No clinically significant history or presence of safety 12-lead ECG findings as judged by the investigator at screening and check-in(s), including each criterion as listed below:
  • Normal sinus rhythm (heart rate between 40 and 100 bpm)
  • QTcF interval </= 470 msec
  • QRS interval </= 110 msec
  • and PRS interval </= 220 msec Repeat measurements may be performed at the discretion of the investigator or designee
  • An understanding, ability, and willingness to fully comply with the protocol-defined schedule of assessments, procedures, and restrictions
  • Must provide written informed consent prior to the initiation of any protocol specific procedures
  • The effects of XER-001 on the developing human fetus are unknown. For this reason women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for at least six months following the last (fifth) day of radiotherapy on this study. Exceptions to this inclusion criterion are available to women who meet any of the following criteria:
  • 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
  • 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.
  • For male participants on this trial, contraception is required as above dusing the study and for at least three months following the last (fifth) day of radiotherapy on this study if the have partners who can become pregnant (woman of child-bearing potential). Similarly, male participants on this trial should not donate sperm during the study and for at lease three months following the last (fifth) day of radiotherapy on this study.

Who cannot join

  • Prior radiotherapy to the upper abdomen with overlap of. the anticipated SBRT field
  • Prior radiopharmaceutical therapy
  • Prior surgical resection of the pancreatic tumor
  • Uncontrolled or active gastric or duodenal ulcer disease within 30 days of enrollment
  • Visable invasion of tumor into the bowel/stomach.duodenal lumen on endoscopic evaluation
  • Residual or ongoing grade 3+ non-hemotological toxicity from chemotherapy other than alopecia
Show all 27Show fewer
  • Concurrent participation in another interventional clinical trial or use of another investigational agent within 30 days of study consent. Note that participation in non-interventional clinical trials (e.g. quality of life [QOL], imaging, etc) is not exclusionary
  • Uncontrolled intercurrent illness including but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, renal failure, cardiac arrhythmia
  • Patients with history of myocardial infarction or unstable angina within 6 months prior to study enrollment
  • Patients with history of symptomatic or (CTCAE-defined) grade 3+ hypocalcemia
  • Patients with history of hypoparathyroidism
  • Patients with history of hypertension where medical providers deem that interruption of antihypertensive regimen for one week is deemed unsafe.
  • Patients with systolic blood pressure (BP) < 100 or diastolic BP < 65 at screening or baseline
  • History or presence of a disease, such as hepatic impairment or renal insufficiency, that could affect the absorption, distribution, metabolism, or elimination of the investigational product, tolerance to radiotherapy, or could affect clinical or laboratory assessments.
  • Patients with an estimated glomerular filtration rate of less than 30 mL per minute are excluded from the trial. Patients with total bilirubin greater than 2.5 mg/dL are excluded from the trial unless patient has history of Gilbert's syndrome. In case of suspected or confirmed Gilbert's syndrome, bilirubin will be fractionated, and patients with direct bilirubin greater than 1.5 mg/dL will be excluded from the trial.
  • History of cardiac-related condition, which may include, but is not limited to, torsades de pointes, ventricular fibrillation, or ventricular tachycardia
  • Presence or family history (parents and siblings) of congenital lqt syndrome or any premature history of myocardial infarction considered clinically significant by the investigator or designee
  • History or presence of palpitations, unexplained syncope, shortness of breath or any other symptoms that may relate to cardiac arrhythmias
  • Any ECG evidence of physiological variants predisposing to electrical instability (eg. frequent pre-ventricular systolic beats)
  • Medical disorder that may require treatment during the study or make the subject unlikely to complete the study.
  • Inability to fast for 3 hours prior to study drug administration
  • Known history of active hepatitis B/C or active human immunodeficiency virus (HIV) not on highly-active anti-retroviral therapy for a minimum of 30 days
  • Donation or loss of more than 500 ml of whole blood within 30 days prior to screening
  • Difficulty with venous access or unstable or unwilling to undergo catheter insertion
  • Female subjects who are currently pregnant (have a positive pregnancy test), are lactating, or planning to breastfeed. Pregnant or breastfeeding women are excluded from this study because there is an unknown risk for adverse events in nursing infants secondary to treatment of the mother with amifostine, breastfeeding should be discontinued if the mother is treated with amifostine
  • An employee of the sponsor or research site personnel directly affiliated with this study or their immediate family member defined as a spouse, parent, child, or sibling, whether biological or legally adopted
  • A subject who, in the opinion of the investigator or designee, is considered unsuitable or unlikely to comply with the study protocol for any reason

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Robbin Frnka contact

2142055746

rfrnka@accelsobio.com

Jeanne Jones contact

jjones@accelsobio.com

5 sites in 1 country

United States5 sites, 5 recruiting

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

    Paige Buzenski Clinical Research Coordinator, 800-527-6266, buzenskip@karmnos.org

    Wasif Saif, MD

    Recruiting

  • City of Hope

    Duarte, California, 91010

    Andrew Fernandez, andfernandez@coh.org

    Percy Lee, MD

    Recruiting

  • Oncology Consultants, P.A.

    Houston, Texas, 77030

    Luis Luna, lluna@oncologyconsultants.com

    Julio Peguero, MD

    Recruiting

  • CIty of Hope

    Irvine, California, 92618

    Xanthia Fajardo, xfajardo@coh.org

    Percy Lee, MD

    Recruiting

  • Christus St. Vincent Regional Cancer Center

    Santa Fe, New Mexico, 87505

    Tamara Flys, PhD, tamara.flys@stvin.org

    Bryan Goss, MD

    Recruiting

Other trials in United States

About this study

Official title: A Phase 1/2a, Open Label, Dose-Escalation Study to Evaluate the Safety and Efficacy of XER-001 (Amifostibe for Nasoduodenal Delivery) in Combination With Sterotactic Body Radiotherapy for Treatment of Locally-Advanced Pancreatic Adenocarcinoma

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

Read the detailed description

The primary objective of the phase 1 component of the study is to evaluate the safety, tolerability, and PK of nasoduodenal administration of XER-001 in conjunction with stereotactic body radiotherapy (SBRT) in patients with LAPC. The primary objective of the phase 2a component of the study is to evaluate safety and efficacy of combination SBRT and XER-001 with increasingly-liberalized duodenal radiation dose constraints.

Being tested
XER-001
Keywords
locally advanced pancreatic cancer, pancreatic cancer, locally advanced pancreatic adenocarcinoma, SBRT, amifostine
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • XER-001Drug

    XER-001 (Amifostine for nasoduodenal delivery)

Study groups in NCT07157033
Study groupRoleWhat they receive
XER-001 at increasing dose levelsExperimentalNot described
Receives: Drug: XER-001

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety Assessments [Dose Escalation]

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

    Measured: 18 Months

  2. Safety Assessments [Dose Escalation]

    Identify the maximum tolerated dose and the RP2D

    Measured: 18 Months

  3. Safety Assessments [Dose escalation and Dose Expansion]

    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

    Measured: 40 months

  4. Safety Assessments [Dose Escalation and Dose Expansion]

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

    Measured: 40 Months

  5. Safety Assessments [Dose Escalation and Dose Expansion]

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

    Measured: 40 Months

  6. Safety Assessments [Dose Escalation and Dose Expansion]

    Gastrointestinal toxicity related to SBRT and LAPC

    Measured: 40 Months

Secondary outcomes (1)

  1. Antitumor Activity

    Local disease control at 6 months per RECIST 1.1

    Measured: 40 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Sep 2025
  2. Study start1 Jan 2026
  3. Primary completion31 Jul 2029 (estimated)
  4. Study completion31 Jul 2034 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07157033
Sponsor's protocol ID
XER-201
Acronym
XER-001
Status last verified
Aug 2026
First submitted
28 Aug 2025
Last updated
17 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing XER-001 in people with Locally Advanced Pancreatic Adenocarcinoma and Locally Advanced Pancreas Cancer, run by Xerient Pharma at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 34 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Robbin Frnka (2142055746, rfrnka@accelsobio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety Assessments [Dose Escalation] (time frame: 18 Months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07157033.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.

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