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Experimental bile duct cancer drug tested in tiny trial – already halted

NCT ID NCT06420349

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial tested a new drug called NXP800 in 7 people with advanced bile duct cancer that had spread or stopped responding to treatment. The goal was to find a safe dose and see if the drug could shrink tumors by blocking a protein linked to cancer growth. However, the study was terminated early, so results are limited and it is not yet known if NXP800 works.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
NXP800
What this could lead to
If it works, this could point toward a new treatment option for advanced bile duct cancer that has stopped responding to standard therapies.
What could go wrong
This was a very early, small Phase 1 trial with only 7 patients, and it has already been terminated. It is unclear if NXP800 is safe or effective, and many early cancer drugs fail to show benefit.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

7 people

The number who actually took part.

Started

May 2024

Finished

Sep 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age ≥ 18 years * Histologically/cytologically confirmed biliary tract cancer * Advanced or metastatic disease that is refractory to gemcitabine or fluoropyrimidine based therapy, or if there is intolerance to these regimens * Measurable disease by RECIST 1.1 * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 * Anticipated life expectancy of \> 12 weeks * Hemoglobin ≥ 9.0 g/dL (obtained ≤ 14 days prior to registration) * Absolute neutrophil count (ANC) ≥ 1500/mm\^3 (obtained ≤ 14 days prior to registration) * Platelet count ≥ 100,000/mm\^3 (obtained ≤ 14 days prior to registration) * Aspartate aminotransferase (AST) ≤ 5 x upper limit of normal (ULN) (obtained ≤ 14 days prior to registration) * Alanine aminotransferase (ALT) ≤ 5 x ULN (obtained ≤ 14 days prior to registration) * Total bilirubin ≤ 1.5 x ULN (obtained ≤ 14 days prior to registration) * Serum creatinine ≤ 1.5 x ULN (obtained ≤ 14 days prior to registration) * Provide written informed consent * Negative pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only * NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required * Willing to use a highly effective method of contraception from the first dose of study medication through 180 days after the last dose of study medication, for persons of childbearing potential or persons able to father a child only * Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study) Exclusion Criteria: * Any of the following because this study involves an investigational agent whose genotoxic, mutagenic, and teratogenic effects on the developing fetus and newborn are unknown: * Pregnant persons. * Nursing persons. * Persons of childbearing potential who are unwilling to employ adequate contraception * Systemic anti-neoplastic therapy or radiation therapy ≤ 14 days prior to registration * Major surgical procedure ≤ 28 days prior to registration * Ongoing therapy related events \> grade 2 * Presence of another primary malignancy not in remission * New York Heart Classification 3 or greater heart failure * QT/corrected QT (QTc) interval \> 470 ms using Fredericia's QT correction formula * Uncontrolled brain metastatic disease * Uncontrolled infection * Any other comorbidities within the opinion of the investigator interfere with the investigation of the protocol * Usage of drugs that strongly inhibit or induce CYP3A4 ≤ 7 days prior to registration and for the duration of NXP800 dosing. Drugs that are low, medium, or other inhibitors of CYP3A4 are not prohibited and should be used with caution. Drugs that inhibit BCRP are not prohibited but should be used with caution, since NXP800 was found to be a BCRP substrate * Usage of seville oranges, grapefruit or grapefruit juice or products ≤ 7 days prior to registration and for the duration of NXP800 dosing * Unwillingness to follow study related procedures * Inability to provide informed consent

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Mayo Clinic in Arizona

    Scottsdale, Arizona, 85259, United States

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905, United States

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Other studies related to the condition(s) this trial covers.