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
- 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
- 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
- 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
- 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
- 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
- Unwilling or unable to follow the study schedule for any reason.