Durvalumab in Combination With a CSF-1R Inhibitor (SNDX-6532) Following Chemo or Radio-Embolization for Patients With Intrahepatic Cholangiocarcinoma

• Status: Recruiting
• Trial end date: 2025-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborators: AstraZeneca; Syndax Pharmaceuticals
• Treatments: Antibodies; Antibodies, Monoclonal; Durvalumab

Criteria

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.