Durvalumab and SNDX-6532 Following Chemo or Radio-Embolization for Patients With Intrahepatic Cholangiocarcinoma

Johns Hopkins Medicine

Status and phase

Completed

Phase 2

Conditions

Unresectable Intrahepatic Cholangiocarcinoma

Treatments

Drug: SNDX-6352

Drug: Durvalumab

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04301778

IRB00233351 (Other Identifier)

J2031

Details and patient eligibility

About

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.

Enrollment

5 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.