Clinical trial · Interventional
Durvalumab and SNDX-6532 Following Chemo or Radio-Embolization for Patients With Intrahepatic Cholangiocarcinoma
A Phase II Study of Durvalumab (MEDI4736) in Combination With a CSF-1R Inhibitor (SNDX-6532) Following Chemo or Radio-Embolization for Patients With Intrahepatic Cholangiocarcinoma.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purposed of this research is to study the safety and clinical activity of the combination of durvalumab and a CSF-1R inhibitor (SNDX-6352) in people with Intrahepatic Cholangiocarcinoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Unresectable Intrahepatic Cholangiocarcinoma | Intrahepatic Cholangiocarcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Durvalumab | Drug | Durvalumab | ALIAS |
| SNDX-6352 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Durvalumab and SNDX-6352
- description
- Participants will receive Durvalumab and SNDX-6352.
- interventionNames
- Drug: Durvalumab
- Drug: SNDX-6352
Primary outcomes (2)
- measure
- Objective Response Rate (ORR) Per mRECIST (Modified RECIST)
- timeFrame
- 8 months
- description
- ORR is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on the Response Evaluation Criteria in Solid Tumors (mRECIST) at any time during the study. CR = disappearance of all target lesions, PR is =\>30% decrease in sum of diameters of target lesions, progressive disease (PD) is \>20% increase in sum of diameters of target lesions, stable disease (SD) is \<30% decrease or \<20% increase in sum of diameters of target lesions. Estimation based on the Kaplan-Meier curve.
- measure
- Number of Participants Experiencing Study Drug-related Toxicities
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
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