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Experimental combo for bile duct cancer shows promise in tiny trial

NCT ID NCT04301778

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 This study
The trial has finished. Results may not be published yet.
Stopped early
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 study tested a combination of two drugs, durvalumab and SNDX-6352, in 5 people with advanced bile duct cancer that had not spread beyond the liver. Participants first received standard chemo or radiation therapy directly into the liver, then the drug combination. The goal was to see if the treatment could shrink tumors and to check for side effects. Because only 5 people took part, the results are very preliminary.

What this could mean

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

Active substance
durvalumab and SNDX-6352 (two drugs given by IV infusion)
What this could lead to
If it works, this combination could offer a new treatment option for people with advanced bile duct cancer that cannot be removed by surgery.
What could go wrong
This was a very small, early-phase trial with only 5 participants, so results may not apply to a larger group. The drugs can cause serious side effects, and the study is already completed without reported outcomes.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

5 people

The number who actually took part.

Started

Aug 2021

Finished

Feb 2024

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: * Have cytologically confirmed intrahepatic cholangiocarcinoma. * All disease must be localized to the liver (locally advanced). * Subjects must not be deemed surgical candidates. * Must be a candidate for conventional transarterial chemoembolization or yttrium-90 radioembolization. * Must have measureable disease be mRECIST. Measurable disease will be confirmed by radiological imaging (MRI, CT). * Age ≥18 years * Body weight \> 30 kg * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Life expectancy ≥12 weeks. * Patient must have adequate organ function defined by the study-specified laboratory tests as per the protocol. * Child Pugh Class A * Measured creatinine clearance (CL) \>40 mL/min or Calculated creatinine clearance CL\>40 mL/min by the Cockcroft-Gault formula. * Woman of childbearing potential must have a negative pregnancy test and follow contraceptive guidelines as defined per protocol. * Must use acceptable form of birth control while on study. * Men must use acceptable form of birth control while on study. * Ability to understand and willingness to sign a written informed consent document. * Willing and able to comply with the protocol for the duration of the study Exclusion Criteria: * Candidate for surgical resection * Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up of an interventional study. * Major surgery within 4 weeks prior to initiation of study treatment. * Received the last dose of anticancer therapy ≤ 28 days prior to the first dose of study drug. * All toxicities NCI CTCAE Grade ≥2 attributed to prior anti-cancer therapy other than alopecia, vitiligo, and neuropathy. * Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. * History of allogenic organ transplantation. * Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[e.g., colitis or Crohn's disease\], diverticulitis \[with the exception of diverticulosis\], systemic lupus erythematosus, Sarcoidosis syndrome, checkpoint inhibitor-induced immune mediated reaction or Wegener syndrome \[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.\]). * Patient with uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, significant muscle disorders or psychiatric illness/social situations that would limit compliance with study requirements. * History of known additional primary malignancies. * History of leptomeningeal carcinomatosis. * Brain metastases or spinal cord compression. * History of active primary immunodeficiency. * Infection with Tuberculosis, HIV or hepatitis B or C at screening. * Current or prior use of immunosuppressive medication within 14 days before the first dose of treatment. * Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. * Pregnant or breastfeeding women. * Has a history of allergy to study treatments or any of its components of the study. * Prior randomization or treatment in a previous durvalumab and/or SNDX-6532 clinical study regardless of treatment arm assignment. * Patient has clinically significant heart disease. * Any other sound medical, psychiatric, and/or social reason as determined by the Investigator. * Unwilling or unable to follow the study schedule for any reason.

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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

  • Sidney Kimmel Comprehensive Cancer Center

    Baltimore, Maryland, 21231, United States

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