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Heat Shock Factor 1 Pathway Inhibitor

NXP800 for Bile Duct Cancer

Phase 1
Recruiting
Led By Mitesh J. Borad, M.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
Histologically/cytologically confirmed biliary tract cancer
Must not have
Major surgical procedure ≤ 28 days prior to registration
Presence of another primary malignancy not in remission
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Summary

"This trial is testing the safety and effectiveness of a drug called NXP800 in treating patients with advanced or metastatic cholangiocarcinoma. NXP800 works by inhibiting a pathway called

Who is the study for?
This trial is for individuals with advanced or metastatic cholangiocarcinoma, which includes various types of bile duct cancer. Participants should have a form of the disease that has spread and are required to undergo specific imaging tests like PET scans, CT scans, MRIs, and biopsies.
What is being tested?
The trial is evaluating NXP800's safety and optimal dosage. NXP800 targets the HSF1 pathway involved in tumor growth and spread. The study will assess if inhibiting this pathway can reduce tumor activity in patients with advanced or metastatic cholangiocarcinoma.
What are the potential side effects?
While specific side effects for NXP800 are not listed here, common ones from drugs targeting pathways in cancer cells include nausea, fatigue, diarrhea, liver issues, skin reactions and potential impact on blood cell counts leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or can carry out light work.
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My cancer diagnosis was confirmed through tissue examination.
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I am 18 years old or older.
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My advanced cancer did not respond to or I cannot tolerate gemcitabine or fluoropyrimidine treatments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not had major surgery in the last 28 days.
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I have another type of cancer that is not currently in remission.
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I have severe heart failure.
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My brain cancer has not been controlled by treatment.
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I do not have any infections that aren't responding to treatment.
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I have no severe side effects from current treatments.
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I haven't had cancer treatment or radiation in the last 2 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum tolerated dose (MTD)
Recommended phase 2 dose
Secondary outcome measures
Best response
Incidence of adverse events
Overall survival (OS)
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (NXP800)Experimental Treatment6 Interventions
Patients receive NXP800 PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, and/or PET at baseline and on study. Patients may optionally undergo ultrasound-guided liver biopsy and/or collection of blood samples on study and during follow up.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 3
~2020
Positron Emission Tomography
2011
Completed Phase 2
~2200
Computed Tomography
2017
Completed Phase 2
~2740
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,298 Previous Clinical Trials
3,958,415 Total Patients Enrolled
15 Trials studying Cholangiocarcinoma
11,774 Patients Enrolled for Cholangiocarcinoma
Mitesh J. Borad, M.D.Principal InvestigatorMayo Clinic
1 Previous Clinical Trials
17 Total Patients Enrolled
~20 spots leftby May 2026
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