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Cancer Vaccine
Immunotherapy for Advanced Skin Cancer
Phase 1
Waitlist Available
Led By Andrew S Brohl, MD
Research Sponsored by TuHURA Biosciences, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days from last injection
Awards & highlights
Study Summary
This trial is testing a new cancer treatment on 20 people. The treatment will be given to up to three areas of cancer on the body, and the person will be monitored for side effects.
Who is the study for?
Adults with advanced non-melanoma skin cancers who have tried standard treatments without success or can't tolerate them. They must be expected to live at least 3 more months, agree to use birth control, and not have serious health issues like uncontrolled heart disease or infections like HIV. Pregnant women and those on high-dose steroids or other immune-suppressing drugs cannot join.Check my eligibility
What is being tested?
The trial is testing IFx-Hu2.0 vaccine given directly into the cancer lesions up to three times. It's for patients with certain types of skin cancer who will be monitored closely for any immediate and delayed side effects over a period following each injection.See study design
What are the potential side effects?
Potential side effects include reactions at the injection site, general symptoms like fatigue, possible bleeding due to intratumoral injections, and immune-related responses since it's an immunotherapy drug.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 28 days from last injection
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days from last injection
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Grade 3-5, Treatment-Related Adverse Events per CTCAE 5.0
Secondary outcome measures
Best Overall Response per RECIST v1.1
Number of Enrolled Subjects who have completed the Trial without Major Protocol Deviations
Objective Response Rate (ORR) per 2018 FDA Guidance on Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics
Trial Design
1Treatment groups
Experimental Treatment
Group I: IFx-Hu2.0 (plasmid DNA) 0.1 mg/lesion/time pointExperimental Treatment1 Intervention
Exposure Escalation:
The first 3 subjects enrolled will receive a fixed IFx-Hu2.0 (plasmid DNA) dose of 0.1 mg injected in up to 3 lesions at a single time point (28-day follow-up post last injection); 3/3 patients recruited.
The second 3 subjects enrolled will receive a fixed IFx-Hu2.0 (plasmid DNA) dose of 0.1 mg injected in up to 3 lesions at 2 time points 7 days apart (28-day follow-up post last injection); 1/3 patients recruited.
The third 3 subjects enrolled will receive a fixed IFx-Hu2.0 (plasmid DNA) dose of 0.1 mg injected in up to 3 lesions at 3 time points 7 days apart (28-day follow-up post last injection); recruitment pending.
Cohort Expansion:
The remaining 11 subjects enrolled will receive a fixed IFx-Hu2.0 (plasmid DNA) dose of 0.1 mg injected in up to 3 lesions at 3 time points 7 days apart (28-day follow-up post last injection); recruitment pending.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
IFx-Hu2.0
2018
Completed Phase 1
~20
Find a Location
Who is running the clinical trial?
TuHURA Biosciences, Inc.Lead Sponsor
3 Previous Clinical Trials
12 Total Patients Enrolled
Morphogenesis, Inc.Lead Sponsor
3 Previous Clinical Trials
12 Total Patients Enrolled
H. Lee Moffitt Cancer Center and Research InstituteOTHER
542 Previous Clinical Trials
135,469 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any uncontrolled serious conditions like HIV or hepatitis.I have had an organ transplant from another person.I am taking more than 10 mg of steroids daily or other drugs that weaken my immune system.I have had cancer treatment within the last 2 weeks.I have or had cancer spread to my brain or spinal cord.I agree to use birth control from the start of the study for up to 6 months after it ends.I have a visible tumor that is larger than 3 mm.I am of childbearing age and have a recent negative pregnancy test.I have a history of significant bleeding due to my tumor or a bleeding disorder.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.My condition worsened despite treatment, or I can't tolerate/chose not to undergo standard treatments.I have a history of hemolytic anemia.I am not pregnant, breastfeeding, nor planning to become pregnant or breastfeed during the study.I haven't had major surgery in the last 14 days or still recovering from one.My lab results show mild or no side effects as per CTCAE v5.0 standards.I have an autoimmune disorder, but it's either vitiligo or an endocrine issue treated with hormones.I don't have any bleeding disorders that make certain cancer tests unsafe.My cancer has spread to the lining of my brain and spinal cord.I can perform all self-care but may not be able to do heavy physical work.I have been diagnosed with advanced skin cancer that is not melanoma.
Research Study Groups:
This trial has the following groups:- Group 1: IFx-Hu2.0 (plasmid DNA) 0.1 mg/lesion/time point
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current enrollment rate for this clinical experiment?
"Affirmative. The clinicaltrials.gov website signals that this medical trial, which was originally posted on March 3rd 2020, is actively recruiting participants. A total of 20 individuals are sought from 4 sites."
Answered by AI
How many research centers are participating in this experiment?
"At present, 4 medical sites are participating in this trial. These locations span from Boston to Tampa and include other cities. In order to alleviate additional stressors associated with travel, it is suggested that interested participants select the clinic nearest them when signing up for the study."
Answered by AI
Are there any vacancies left in this experiment for participants?
"Clinicaltrials.gov confirms that this medical study, which was initially posted on March 3rd 2020, is actively recruiting participants. The trial's information was last edited on December 1st 2022."
Answered by AI
What adverse effects might IFx-Hu2.0 pose for participants?
"We estimate IFx-Hu2.0's safety to be a 1, as the data in support of its efficacy and security is limited due to this experiment being at Phase 1."
Answered by AI
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