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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study ID
NCT04301778
Phase
PHASE2
Status
Completed

Conditions

  • Unresectable Intrahepatic Cholangiocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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
  • 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

Study Details

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.

Key Dates

Start date
Aug 24, 2021
Status verified
Feb 2026
Primary completion
Nov 4, 2022
Completion
Feb 6, 2024

Study Design

Enrollment
5 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Durvalumab and SNDX-6352
    Participants will receive Durvalumab and SNDX-6352.

Primary Outcome Measure

Objective Response Rate (ORR) Per mRECIST (Modified RECIST) [ Time Frame: 8 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Sidney Kimmel Comprehensive Cancer CenterBaltimoreMaryland21231-

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By research site
Sidney Kimmel Comprehensive Cancer Center· Baltimore, MD

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