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

NCT04301778 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: J2031IRB00233351
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Unresectable Intrahepatic Cholangiocarcinoma

Keywords

colony stimulating factor -1 receptor (CSF-1R) inhibitor; Anti-PD-1 (receptor blocking antibody); Immunotherapy; Intra-arterial therapy; Y90 (yttrium-90 radioembolization); conventional transarterial chemoembolization (cTACE); Chemo-embolization; Radio-embolization; Biliary tract; Intrahepatic Cholangiocarcinoma; Monoclonal antibody

Outcome Measures

Primary Outcomes (2)

• Objective Response Rate (ORR) Per mRECIST (Modified RECIST)

  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.

  8 months

• Number of Participants Experiencing Study Drug-related Toxicities

  Number of participants who experience treatment related adverse events ≥ grade 3 as defined by CTCAE 5.0.

  up to 1 year

Secondary Outcomes (3)

• Overall Survival (OS)

  up to 2 years

• Progression-free Survival (PFS) Per mRECIST

  8 months

• Duration of Response (DOR)

  8 months

Study Arms (1)

Durvalumab and SNDX-6352

EXPERIMENTAL

Participants will receive Durvalumab and SNDX-6352.

Drug: Durvalumab; Drug: SNDX-6352

Interventions

Durvalumab DRUG

1. Durvalumab - 1500 mg via IV infusion over 60 minutes (-5/+10 min) on day 1 of each 28-day cycle (every 4 weeks). 2. Drug - 1500mg IV

Also known as: MEDI4736

Durvalumab and SNDX-6352

SNDX-6352 DRUG

1. SNDX-6352 - 3mg/kg via IV infusion over 30 minutes (-5/+10 min) on days 1 and 15 of each 28-day cycle (every 2 weeks), starting with cycle 2 (not given during cycle 1). 2. Drug - 3mg/kg IV

Also known as: UCB6352

Durvalumab and SNDX-6352

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Syndax Pharmaceuticals: collaborator
• AstraZeneca: collaborator
• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21231, United States

Location

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

durvalumab; axatilimab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Results Point of Contact

• Title: Marina Baretti, MD
• Organization: Sidney Kimmel Cancer Center at Johns Hopkins

mbarett1@jhu.edu

410-614-4626

Study Officials

• Lei Zheng, MD

  Sidney Kimmel Cancer Center at the Johns Hopkins Medical Institution

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2020
• First Posted: March 10, 2020
• Study Start: August 24, 2021
• Primary Completion: November 4, 2022
• Study Completion: February 6, 2024
• Last Updated: March 13, 2026
• Results First Posted: March 31, 2023

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)