Status:
COMPLETED
Durvalumab and SNDX-6532 Following Chemo or Radio-Embolization for Patients With Intrahepatic Cholangiocarcinoma
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
Syndax Pharmaceuticals
AstraZeneca
Conditions:
Unresectable Intrahepatic Cholangiocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 6 2024
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04301778
Start Date
August 24 2021
End Date
February 6 2024
Last Update
February 11 2025
Active Locations (1)
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1
Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21231