Experimental combo for bile duct cancer shows promise in tiny trial
NCT ID NCT04301778
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
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Aug 2021
- Finished
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Feb 2024
- Lead sponsor
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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
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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 Hide 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
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Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21231, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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