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CD24Fc for the Treatment of Immune Related Adverse Events in Patients With Advanced Solid Tumors, TIRAEC Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04552704
Recruitment Status : Terminated (Terminated early by the Sponsor due to the sponsor change.)
First Posted : September 17, 2020
Results First Posted : April 4, 2022
Last Update Posted : April 4, 2022
Sponsor:
Collaborators:
National Cancer Institute (NCI)
OncoImmune, Inc.
Information provided by (Responsible Party):
Tianhong Li, University of California, Davis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Advanced Malignant Solid Neoplasm
Interventions Biological: CD24 Extracellular Domain-IgG1 Fc Domain Recombinant Fusion Protein CD24Fc
Drug: Placebo Administration
Enrollment 3
Recruitment Details The study was terminated by the sponsor after 3 out of 6 patients enrolled in phase I study.
Pre-assignment Details  
Arm/Group Title Phase I
Hide Arm/Group Description Patients receive CD24Fc IV over 60 minutes on days 1, 14, and 28 with standard of care.
Period Title: Overall Study
Started 3
Completed 3
Not Completed 0
Arm/Group Title Phase I (CD24Fc) Phase II, Arm I (CD24Fc) Phase II, Arm II (Placebo) Total
Hide Arm/Group Description

Patients receive CD24Fc IV over 60 minutes on days 1, 14, and 28 with standard of care (i.e., steroids per treating physician and best supportive care) in the absence of disease progression or unacceptable toxicity.

CD24 Extracellular Domain-IgG1 Fc Domain Recombinant Fusion Protein CD24Fc: Given IV

Patients receive CD24Fc IV over 60 minutes on days 1, 14, and 28 in addition to standard of care treatment for irAE in the absence of disease progression or unacceptable toxicity.

CD24 Extracellular Domain-IgG1 Fc Domain Recombinant Fusion Protein CD24Fc: Given IV

Patients receive placebo IV over 60 minutes on days 1, 14, and 28 in addition to standard of care treatment for irAE in the absence of disease progression or unacceptable toxicity.

Placebo Administration: Given IV

 Total of all reporting groups
Overall Number of Baseline Participants 3 0 0 3
Hide Baseline Analysis Population Description
The study was terminated by the sponsor after 3 out of 6 patients enrolled in phase I study.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 0 participants 0 participants 3 participants
<=18 years
0
   0.0%
0
   0.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
>=65 years
3
 100.0%
3
 100.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 0 participants 0 participants 3 participants
Female
1
  33.3%
1
  33.3%
Male
2
  66.7%
2
  66.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 0 participants 0 participants 3 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
White
3
 100.0%
3
 100.0%
More than one race
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants 0 participants 0 participants 3 participants
3 3
1.Primary Outcome
Title Incidence of New Adverse Event (AE) of >= Grade 3 (Phase I)
Hide Description Will assess event of new AE of >= grade 3 that are outside the spectrum of immune related adverse events (irAEs) when CD24 extracellular domain-IgG1 Fc domain recombinant fusion protein CD24Fc (CD24Fc) is given in cancer patients who developed grade 2-3 irAEs. Toxicity is evaluated by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0. The type, grade, frequency and proportion of toxicities noted during the treatment period will be reported, along with associated 95% confidence interval of proportion. All adverse events noted by the investigator will be tabulated according to the affected body system.
Time Frame At day 60
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phase I
Hide Arm/Group Description:
Patients receive CD24Fc IV over 60 minutes on days 1, 14, and 28 with standard of care.
Overall Number of Participants Analyzed 3
Measure Type: Count of Participants
Unit of Measure: Participants
1
  33.3%
2.Primary Outcome
Title Recovery Rate (Phase II)
Hide Description Defined by reduction of irAE by one grade. Kaplan-Meier plots and confidence intervals will be used to summarize outcomes. Medians and associated 95% confidence intervals will be calculated, and comparisons between groups will be performed by log-rank tests. Cox proportional hazard models will be used to explore association between covariates and outcomes.
Time Frame At day 42
Hide Outcome Measure Data
Hide Analysis Population Description
Study was terminated during Phase 1 portion of study.
Arm/Group Title Phase II
Hide Arm/Group Description:

Patients receive CD24Fc IV over 60 minutes on days 1, 14, and 28 in addition to standard of care treatment for irAE in the absence of disease progression or unacceptable toxicity.

CD24 Extracellular Domain-IgG1 Fc Domain Recombinant Fusion Protein CD24Fc: Given IV
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Primary Outcome
Title Time to Recovery From Grade 2 or 3 irAE (Phase II)
Hide Description Will assess time to recovery from grade 2 or 3 irAE (as defined by reduction of at least 1 grade in irAE severity) from the initiation of CD24Fc treatment. Patients who have not been documented to have event (reduction of at least 1 grade) will be censored at the date of the latest clinical assessment that documented as being free of event.
Time Frame Up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Study was terminated during Phase 1 portion of study.
Arm/Group Title Phase II
Hide Arm/Group Description:

Patients receive CD24Fc IV over 60 minutes on days 1, 14, and 28 in addition to standard of care treatment for irAE in the absence of disease progression or unacceptable toxicity.

CD24 Extracellular Domain-IgG1 Fc Domain Recombinant Fusion Protein CD24Fc: Given IV
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Time to irAE Reduction by at Least 1 Grade From the Initiation of CD24Fc Treatment (Phase I)
Hide Description Kaplan-Meier plots and confidence intervals will be used to summarize outcomes. Medians and associated 95% confidence intervals will be calculated, and comparisons between groups will be performed by log-rank tests. Cox proportional hazard models will be used to explore association between covariates and outcomes.
Time Frame Up to 1 year
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Time to All irAEs Reduced to =< 1 From the Initiation of CD24Fc Treatment (Phase I)
Hide Description Assessed by NCI CTCAE v5.0. Kaplan-Meier plots and confidence intervals will be used to summarize outcomes. Medians and associated 95% confidence intervals will be calculated, and comparisons between groups will be performed by log-rank tests. Cox proportional hazard models will be used to explore association between covariates and outcomes.
Time Frame Up to 1 year
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Time to Resume Immune Check Point Inhibitor (ICI) Treatment From the Initiation of CD24Fc Treatment (Phase I)
Hide Description Kaplan-Meier plots and confidence intervals will be used to summarize outcomes. Medians and associated 95% confidence intervals will be calculated, and comparisons between groups will be performed by log-rank tests. Cox proportional hazard models will be used to explore association between covariates and outcomes.
Time Frame Up to 1 year
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Recovery Rate (Reduction of irAE by One Grade) (Phase I)
Hide Description The fraction of patients who experience a partial response (PR) or complete response (CR) will be determined by dividing the number of responders by the total evaluable patients. The fraction will be reported along with 95% two-sided confidence intervals. Comparisons between groups will be performed by Fisher's Exact tests. Will also characterize the proportion who remain that either respond or have stable disease, compared to those who progress.
Time Frame At day 42
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Time to All irAEs Reduced to =< 1 From the Initiation of CD24Fc Treatment (Phase II)
Hide Description Assessed by NCI CTCAE v5.0. Kaplan-Meier plots and confidence intervals will be used to summarize outcomes. Medians and associated 95% confidence intervals will be calculated, and comparisons between groups will be performed by log-rank tests. Cox proportional hazard models will be used to explore association between covariates and outcomes.
Time Frame Up to 1 year
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Use of Steroids and Other Drugs (Drug, Dose, Duration) (Phase II)
Hide Description Descriptive statistics will be used to summarize use of steroids (drug, dose, duration) and other treatment for irAE.
Time Frame Up to 1 year
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Overall Response Rate After Retreatment With ICI With or Without CD24Fc After Resolution of irAE (Phase II)
Hide Description The fraction of patients who experience a PR or CR will be determined by dividing the number of responders by the total evaluable patients. The fraction will be reported along with 95% two-sided confidence intervals. Comparisons between groups will be performed by Fisher's Exact tests. Will also characterize the proportion who remain that either respond or have stable disease, compared to those who progress.
Time Frame Up to 1 year
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Progression Free Survival (PFS) (Phase II)
Hide Description Kaplan-Meier plots and confidence intervals will be used to summarize PFS; medians and associated 95% confidence intervals will be calculated, and comparisons between groups will be performed by log-rank tests. Cox PH models will be used to explore association between outcomes and covariates.
Time Frame From initiation of ICI to first documented evidence of disease progression or death, whichever comes first, assessed up to 1 year
Outcome Measure Data Not Reported
12.Secondary Outcome
Title Overall Survival (OS) (Phase II)
Hide Description Kaplan-Meier plots and confidence intervals will be used to summarize OS; medians and associated 95% confidence intervals will be calculated, and comparisons between groups will be performed by log-rank tests. Cox PH models will be used to explore association between outcomes and covariates.
Time Frame From diagnosis to death, assessed up to 1 year
Outcome Measure Data Not Reported
Time Frame Up to 60 days
Adverse Event Reporting Description All Serious Adverse Events listed were unlikely related to study treatment. All adverse events listed were unrelated or unlikely related to study treatment, with the exception of alanine aminotransferase increased, aspartate aminotransferase increased, palor, diarrhea, nausea, vomiting, blood bicarbonate decreased, weight gain, anorexia, and hyponatremia, which were possibly or probably related to study treatment.
 
Arm/Group Title Phase I
Hide Arm/Group Description Patients receive CD24Fc IV over 60 minutes on days 1, 14, and 28 with standard of care.
All-Cause Mortality
Phase I
Affected / at Risk (%)
Total   1/3 (33.33%) 
Hide Serious Adverse Events
Phase I
Affected / at Risk (%)
Total   1/3 (33.33%) 
Gastrointestinal disorders   
Dysphagia * 1  1/3 (33.33%) 
Odynophagia * 1  1/3 (33.33%) 
General disorders   
Fever * 1  1/3 (33.33%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea * 1  1/3 (33.33%) 
Pneumonia * 1  1/3 (33.33%) 
1
Term from vocabulary, CTCAE (5.0)
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Phase I
Affected / at Risk (%)
Total   3/3 (100.00%) 
Blood and lymphatic system disorders   
Anemia * 1  1/3 (33.33%) 
Palor * 1  1/3 (33.33%) 
Gastrointestinal disorders   
Diarrhea * 1  1/3 (33.33%) 
Heart burn * 1  1/3 (33.33%) 
Nausea * 1  1/3 (33.33%) 
Vomiting * 1  1/3 (33.33%) 
General disorders   
Fatigue * 1  1/3 (33.33%) 
Infections and infestations   
Hepatic infection * 1  1/3 (33.33%) 
Infections and infestations - ascending thoracic aneurysm * 1  1/3 (33.33%) 
Infections and infestations - BUN decreased * 1  1/3 (33.33%) 
Infections and infestations - tachypnea * 1  1/3 (33.33%) 
Investigations   
Blood bicarbonate decreased * 1  3/3 (100.00%) 
Blood bilirubin increased * 1  1/3 (33.33%) 
Lymphocyte count decreased * 1  1/3 (33.33%) 
Platelet count decreased * 1  1/3 (33.33%) 
White blood cell decreased * 1  1/3 (33.33%) 
Alanine aminotransferase increased * 1  2/3 (66.67%) 
Aspartate aminotransferase increased * 1  2/3 (66.67%) 
Alkaline phosphatase increased * 1  1/3 (33.33%) 
Elevated neutrophil * 1  1/3 (33.33%) 
GGT elevated * 1  1/3 (33.33%) 
WBC elevated * 1  1/3 (33.33%) 
Metabolism and nutrition disorders   
Hyperglycemia * 1  2/3 (66.67%) 
Hypocalcemia * 1  1/3 (33.33%) 
Hypokalemia * 1  1/3 (33.33%) 
Hyponatremia * 1  2/3 (66.67%) 
Anorexia * 1  1/3 (33.33%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
New lingular plueral-based opacity with increased FDG * 1  1/3 (33.33%) 
Possible new segment 2 metastatic lesion * 1  1/3 (33.33%) 
Respiratory, thoracic and mediastinal disorders   
Hypoxia * 1  2/3 (66.67%) 
Pneumonitis * 1  1/3 (33.33%) 
Cough * 1  1/3 (33.33%) 
Productive cough * 1  1/3 (33.33%) 
Left vocal chord paralysis * 1  1/3 (33.33%) 
1
Term from vocabulary, CTCAE (5.0)
*
Indicates events were collected by non-systematic assessment
The study was terminated by the sponsor after 3 out of 6 patients enrolled in phase I study.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Analyst
Organization: University of California, Davis
Phone: 916-734-8053
EMail: nlogihara@ucdavis.edu
Layout table for additonal information
Responsible Party: Tianhong Li, University of California, Davis
ClinicalTrials.gov Identifier: NCT04552704    
Other Study ID Numbers: 1626396
NCI-2020-05955 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
UCDCC#292 ( Other Identifier: University of California Davis Comprehensive Cancer Center )
P30CA093373 ( U.S. NIH Grant/Contract )
CD24Fc-006 ( Other Grant/Funding Number: OncoImmune, Inc. )
First Submitted: September 10, 2020
First Posted: September 17, 2020
Results First Submitted: March 8, 2022
Results First Posted: April 4, 2022
Last Update Posted: April 4, 2022