Trial Outcomes & Findings for IFx-Hu2.0 for the Treatment of Patients With Skin Cancer (NCT NCT04925713)
NCT ID: NCT04925713
Last Updated: 2024-08-02
Results Overview
Rate of Adverse Events reported per Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
5 participants
Primary outcome timeframe
28 days post injection
Results posted on
2024-08-02
Participant Flow
Participant milestones
| Measure |
IFx-Hu2.0 (Plasmid DNA) 0.1 mg/Lesion
Biological: IFx-Hu2.0 The investigational drug product IFx-Hu2.0 is composed of the drug substance pAc/emm55 (pDNA) complexed with the two excipients in vivo-jetPEI® (linear polyethylenimine), a transfection reagent, and dextrose, a pDNA/polyethylenimine complex stabilizer.
Therapeutic Classification:
Immunomodulatory Agent
Route of Administration:
Intralesional (i.e. injection of cutaneous, subcutaneous or lymph nodal lesions)
Mechanism of Action:
Injection of IFx-Hu2.0 into the lesion facilitates the expression of the immunogenic Emm55 protein by the tumor cells.
Physiological Effect:
Expression of the emm55 gene by the tumor cells triggers immune recognition of tumor-specific and -associated antigens which leads to innate and adaptive immune responses.
Other Name: pAc/emm55
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
IFx-Hu2.0 for the Treatment of Patients With Skin Cancer
Baseline characteristics by cohort
| Measure |
IFx-Hu2.0 (Plasmid DNA) 0.1 mg/Lesion
n=5 Participants
One hundred (100) patients will receive 0.1 mg of IFx-Hu2.0 injected intratumorally in a single lesion at a single time point and be followed-up 28 days thereafter.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=99 Participants
|
|
Cutaneous Squamous Cell Carcinoma
|
2 Participants
n=99 Participants
|
|
Basal Cell Carcinoma
|
3 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 28 days post injectionRate of Adverse Events reported per Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Outcome measures
| Measure |
IFx-Hu2.0 (Plasmid DNA) 0.1 mg/Lesion
n=5 Participants
One hundred (100) patients will receive 0.1 mg of IFx-Hu2.0 injected intratumorally in a single lesion at a single time point and be followed-up 28 days thereafter.
|
|---|---|
|
Rate of Adverse Events
Serious Adverse Events (SAEs)
|
0 Participants
|
|
Rate of Adverse Events
Dose Limiting Toxicity (DLT)
|
0 Participants
|
|
Rate of Adverse Events
Participants Analyzed
|
5 Participants
|
PRIMARY outcome
Timeframe: 28 days post injectionNumber of Patients who completed the trial per protocol without major deviations.
Outcome measures
| Measure |
IFx-Hu2.0 (Plasmid DNA) 0.1 mg/Lesion
n=5 Participants
One hundred (100) patients will receive 0.1 mg of IFx-Hu2.0 injected intratumorally in a single lesion at a single time point and be followed-up 28 days thereafter.
|
|---|---|
|
Number of Patients Who Completed the Trial [Time Frame: 28 Days Post Injection]
Number of Patients who did not completed the trial
|
0 Participants
|
|
Number of Patients Who Completed the Trial [Time Frame: 28 Days Post Injection]
Number of Patients who completed the trial
|
5 Participants
|
Adverse Events
IFx-Hu2.0 (Plasmid DNA) 0.1 mg/Lesion
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
James Bianco, MD - Chief Executive Officer
Morphogenesis, Inc
Phone: 8138756600
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place