Trial Outcomes & Findings for Durvalumab and SNDX-6532 Following Chemo or Radio-Embolization for Patients With Intrahepatic Cholangiocarcinoma (NCT NCT04301778)

Last Updated: 2025-02-11

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

5 participants

Primary outcome timeframe

8 months

Results posted on

2025-02-11

Participant Flow

Participant milestones

Participant milestones
Measure	Durvalumab and SNDX-6352 Participants received Durvalumab and SNDX-6352. Durvalumab: 1500 mg IV over 60 minutes on day 1 of each 28-day cycle (every 4 weeks). SNDX-6352: 3mg/kg IV over 30 minutes on days 1 and 15 of each 28-day cycle (every 2 weeks), starting with cycle 2 (not given during cycle 1).
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Durvalumab and SNDX-6352 n=5 Participants Participants received Durvalumab and SNDX-6352. Durvalumab: 1500 mg IV over 60 minutes on day 1 of each 28-day cycle (every 4 weeks). SNDX-6352: 3mg/kg IV over 30 minutes on days 1 and 15 of each 28-day cycle (every 2 weeks), starting with cycle 2 (not given during cycle 1).
Age, Continuous	60 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	5 Participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG 0	4 Participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG 1	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 8 months

Outcome measures

Outcome measures
Measure	Durvalumab and SNDX-6352 n=5 Participants Participants received Durvalumab and SNDX-6352. Durvalumab: 1500 mg IV over 60 minutes on day 1 of each 28-day cycle (every 4 weeks). SNDX-6352: 3mg/kg IV over 30 minutes on days 1 and 15 of each 28-day cycle (every 2 weeks), starting with cycle 2 (not given during cycle 1).
Objective Response Rate (ORR) Per mRECIST (Modified RECIST)	1 Participants

PRIMARY outcome

Timeframe: up to 1 year

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

Outcome measures

Outcome measures
Measure	Durvalumab and SNDX-6352 n=5 Participants Participants received Durvalumab and SNDX-6352. Durvalumab: 1500 mg IV over 60 minutes on day 1 of each 28-day cycle (every 4 weeks). SNDX-6352: 3mg/kg IV over 30 minutes on days 1 and 15 of each 28-day cycle (every 2 weeks), starting with cycle 2 (not given during cycle 1).
Number of Participants Experiencing Study Drug-related Toxicities	2 Participants

SECONDARY outcome

Timeframe: up to 2 years

OS is defined as the number of months from the start of study treatment to time of death. Individuals are censored at the date of the last contact if no event occurs. The estimation method used was Kaplan-Meier.

Outcome measures

Outcome measures
Measure	Durvalumab and SNDX-6352 n=5 Participants Participants received Durvalumab and SNDX-6352. Durvalumab: 1500 mg IV over 60 minutes on day 1 of each 28-day cycle (every 4 weeks). SNDX-6352: 3mg/kg IV over 30 minutes on days 1 and 15 of each 28-day cycle (every 2 weeks), starting with cycle 2 (not given during cycle 1).
Overall Survival (OS)	15.3 months Interval 14.2 to upper limit not reached

SECONDARY outcome

Timeframe: 8 months

PFS is defined as the number of months from the date of treatment to disease recurrence \[disease recurrence (DR) progressive disease (PD) or relapse from complete response (CR) as assessed using mRECIST criteria\] or death due to any cause. Per mRECIST criteria, CR = disappearance of all target lesions, Partial Response (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.

Outcome measures

Outcome measures
Measure	Durvalumab and SNDX-6352 n=5 Participants Participants received Durvalumab and SNDX-6352. Durvalumab: 1500 mg IV over 60 minutes on day 1 of each 28-day cycle (every 4 weeks). SNDX-6352: 3mg/kg IV over 30 minutes on days 1 and 15 of each 28-day cycle (every 2 weeks), starting with cycle 2 (not given during cycle 1).
Progression-free Survival (PFS) Per mRECIST	3.6 months Interval 1.8 to upper limit not reached

SECONDARY outcome

Timeframe: 8 months

Population: Only patients with either a partial or complete response by mRECIST are included in the analysis.

Number of days from the start of partial response (PR) or complete response (CR) by radiographic scans, whichever is recorded first, until the first date that progressive disease or death is documented. Per mRECIST, CR = disappearance of any intratumoral arterial enhancement in all target lesions, PR is =\>30% decrease in sum of diameters of target lesions.

Outcome measures

Outcome measures
Measure	Durvalumab and SNDX-6352 n=1 Participants Participants received Durvalumab and SNDX-6352. Durvalumab: 1500 mg IV over 60 minutes on day 1 of each 28-day cycle (every 4 weeks). SNDX-6352: 3mg/kg IV over 30 minutes on days 1 and 15 of each 28-day cycle (every 2 weeks), starting with cycle 2 (not given during cycle 1).
Duration of Response (DOR)	57 days

Adverse Events

Durvalumab and SNDX-6352

Serious events: 1 serious events

Other events: 5 other events

Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure	Durvalumab and SNDX-6352 n=5 participants at risk Participants received Durvalumab and SNDX-6352. Durvalumab: 1500 mg IV over 60 minutes on day 1 of each 28-day cycle (every 4 weeks). SNDX-6352: 3mg/kg IV over 30 minutes on days 1 and 15 of each 28-day cycle (every 2 weeks), starting with cycle 2 (not given during cycle 1).
Infections and infestations Skin infection	20.0% 1/5 • Number of events 1 • Adverse events were collected from start of study drug until 90 days from last dose of study drug, up to 1 year. Patients were followed for survival (all-cause mortality) for up to 2 years Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.
Vascular disorders Ruptured femoral pseudoaneurysm	20.0% 1/5 • Number of events 1 • Adverse events were collected from start of study drug until 90 days from last dose of study drug, up to 1 year. Patients were followed for survival (all-cause mortality) for up to 2 years Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.

Other adverse events

Other adverse events
Measure	Durvalumab and SNDX-6352 n=5 participants at risk Participants received Durvalumab and SNDX-6352. Durvalumab: 1500 mg IV over 60 minutes on day 1 of each 28-day cycle (every 4 weeks). SNDX-6352: 3mg/kg IV over 30 minutes on days 1 and 15 of each 28-day cycle (every 2 weeks), starting with cycle 2 (not given during cycle 1).
Blood and lymphatic system disorders Anemia	20.0% 1/5 • Number of events 1 • Adverse events were collected from start of study drug until 90 days from last dose of study drug, up to 1 year. Patients were followed for survival (all-cause mortality) for up to 2 years Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.
Gastrointestinal disorders Abdominal pain	80.0% 4/5 • Number of events 6 • Adverse events were collected from start of study drug until 90 days from last dose of study drug, up to 1 year. Patients were followed for survival (all-cause mortality) for up to 2 years Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.
Gastrointestinal disorders Ascites	20.0% 1/5 • Number of events 1 • Adverse events were collected from start of study drug until 90 days from last dose of study drug, up to 1 year. Patients were followed for survival (all-cause mortality) for up to 2 years Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.
Gastrointestinal disorders Constipation	40.0% 2/5 • Number of events 2 • Adverse events were collected from start of study drug until 90 days from last dose of study drug, up to 1 year. Patients were followed for survival (all-cause mortality) for up to 2 years Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.
Gastrointestinal disorders Diarrhea	20.0% 1/5 • Number of events 1 • Adverse events were collected from start of study drug until 90 days from last dose of study drug, up to 1 year. Patients were followed for survival (all-cause mortality) for up to 2 years Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.
Gastrointestinal disorders Hemorrhoidal hemorrhage	20.0% 1/5 • Number of events 1 • Adverse events were collected from start of study drug until 90 days from last dose of study drug, up to 1 year. Patients were followed for survival (all-cause mortality) for up to 2 years Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.
Gastrointestinal disorders Nausea	60.0% 3/5 • Number of events 4 • Adverse events were collected from start of study drug until 90 days from last dose of study drug, up to 1 year. Patients were followed for survival (all-cause mortality) for up to 2 years Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.
Gastrointestinal disorders Vomiting	20.0% 1/5 • Number of events 2 • Adverse events were collected from start of study drug until 90 days from last dose of study drug, up to 1 year. Patients were followed for survival (all-cause mortality) for up to 2 years Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.
General disorders Edema limbs	20.0% 1/5 • Number of events 1 • Adverse events were collected from start of study drug until 90 days from last dose of study drug, up to 1 year. Patients were followed for survival (all-cause mortality) for up to 2 years Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.
General disorders Generalized edema	20.0% 1/5 • Number of events 1 • Adverse events were collected from start of study drug until 90 days from last dose of study drug, up to 1 year. Patients were followed for survival (all-cause mortality) for up to 2 years Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.
General disorders Fatigue	80.0% 4/5 • Number of events 5 • Adverse events were collected from start of study drug until 90 days from last dose of study drug, up to 1 year. Patients were followed for survival (all-cause mortality) for up to 2 years Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.
General disorders Pain at biopsy site	40.0% 2/5 • Number of events 2 • Adverse events were collected from start of study drug until 90 days from last dose of study drug, up to 1 year. Patients were followed for survival (all-cause mortality) for up to 2 years Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.
Investigations ALT increased	20.0% 1/5 • Number of events 1 • Adverse events were collected from start of study drug until 90 days from last dose of study drug, up to 1 year. Patients were followed for survival (all-cause mortality) for up to 2 years Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.
Investigations AST increased	80.0% 4/5 • Number of events 8 • Adverse events were collected from start of study drug until 90 days from last dose of study drug, up to 1 year. Patients were followed for survival (all-cause mortality) for up to 2 years Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.
Investigations Blood LDH increased	40.0% 2/5 • Number of events 3 • Adverse events were collected from start of study drug until 90 days from last dose of study drug, up to 1 year. Patients were followed for survival (all-cause mortality) for up to 2 years Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.
Investigations CPK increased	80.0% 4/5 • Number of events 13 • Adverse events were collected from start of study drug until 90 days from last dose of study drug, up to 1 year. Patients were followed for survival (all-cause mortality) for up to 2 years Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.
Investigations Weight loss	60.0% 3/5 • Number of events 3 • Adverse events were collected from start of study drug until 90 days from last dose of study drug, up to 1 year. Patients were followed for survival (all-cause mortality) for up to 2 years Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.
Metabolism and nutrition disorders Anorexia	20.0% 1/5 • Number of events 1 • Adverse events were collected from start of study drug until 90 days from last dose of study drug, up to 1 year. Patients were followed for survival (all-cause mortality) for up to 2 years Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.
Investigations Hypokalemia	20.0% 1/5 • Number of events 1 • Adverse events were collected from start of study drug until 90 days from last dose of study drug, up to 1 year. Patients were followed for survival (all-cause mortality) for up to 2 years Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.
Musculoskeletal and connective tissue disorders Arthralgia	40.0% 2/5 • Number of events 2 • Adverse events were collected from start of study drug until 90 days from last dose of study drug, up to 1 year. Patients were followed for survival (all-cause mortality) for up to 2 years Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.
Musculoskeletal and connective tissue disorders Arthritis	20.0% 1/5 • Number of events 1 • Adverse events were collected from start of study drug until 90 days from last dose of study drug, up to 1 year. Patients were followed for survival (all-cause mortality) for up to 2 years Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.
Musculoskeletal and connective tissue disorders Back pain	40.0% 2/5 • Number of events 2 • Adverse events were collected from start of study drug until 90 days from last dose of study drug, up to 1 year. Patients were followed for survival (all-cause mortality) for up to 2 years Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.
Musculoskeletal and connective tissue disorders Pain in Extremity	20.0% 1/5 • Number of events 1 • Adverse events were collected from start of study drug until 90 days from last dose of study drug, up to 1 year. Patients were followed for survival (all-cause mortality) for up to 2 years Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.
Nervous system disorders Headache	20.0% 1/5 • Number of events 1 • Adverse events were collected from start of study drug until 90 days from last dose of study drug, up to 1 year. Patients were followed for survival (all-cause mortality) for up to 2 years Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.
Skin and subcutaneous tissue disorders Rash acneiform	20.0% 1/5 • Number of events 1 • Adverse events were collected from start of study drug until 90 days from last dose of study drug, up to 1 year. Patients were followed for survival (all-cause mortality) for up to 2 years Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.

Additional Information

Lei Zheng, MD PhD

Sidney Kimmel Cancer Center at Johns Hopkins

Phone: 646-239-3110

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place