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Virus Therapy
VP-315 / LTX-315 for Skin Cancer
Phase 2
Recruiting
Led By Neal Bhatia, MD
Research Sponsored by Verrica Pharmaceuticals Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
For punch biopsies: the size of the lesion(s) must be ≥0.5 cm and </=2 cm in the longest diameter prior to punch biopsy
Willing to practice a highly effective method of birth control while on study and until 4 weeks after the last treatment. Highly effective birth control includes sexual abstinence, vasectomy, bilateral tubal ligation/occlusion, or a condom with spermicide (men) combined with hormonal birth control or intrauterine device in women
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 84-91
Awards & highlights
Study Summary
This trial is designed to assess the safety and effectiveness of a new treatment for skin cancer. Researchers will enroll 66 people with skin cancer and administer escalating doses of the new medication to see what is safe and what works.
Who is the study for?
Adults over 18 with suspected basal cell carcinoma (BCC) suitable for biopsy and excision can join this trial. They must have 1-5 lesions, avoid sun/UV light, use effective birth control, and not apply nonapproved topical agents near the lesions. Excluded are those with high-risk BCCs, recent surgeries or treatments, certain chronic conditions or drug abuse.Check my eligibility
What is being tested?
The study tests VP-315 Part 2 and LTX-315 Part 1 drugs on people with basal cell carcinoma by injecting them directly into tumors to see how safe they are and how well they work at different doses. It's an open-label trial where everyone knows what treatment they're getting.See study design
What are the potential side effects?
Possible side effects of VP-315 and LTX-315 may include reactions at the injection site like pain or swelling, general skin irritation around treated areas, fatigue from treatment sessions, or other immune-related responses due to the nature of these cancer-fighting drugs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lesion is between 0.5 cm and 2 cm in size before a biopsy.
Select...
I will use effective birth control during and 4 weeks after the study.
Select...
I am willing to avoid direct sunlight and tanning parlors during the study.
Select...
I am willing to have surgery for my basal cell carcinoma after the study treatment.
Select...
I have 1 to 5 skin lesions suspected to be basal cell carcinoma, suitable for removal.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 84-91
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 84-91
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part 1: Percentage of subjects with Cutaneous Reaction by severity
Part 1: Percentage of subjects with discontinuations due to adverse events
Part 1: Percentage of subjects with dose-limiting toxicities (DLTs)
+4 moreSecondary outcome measures
Part 2 (Cohorts 4 and 5 expansion groups): Plasma concentrations of VP-315
Part 2: Mean estimated remaining tumor volume at excision
Part 2: Percent of subjects with Physician's Global Assessment by scale
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Part 2 VP-315 Regimen FindingExperimental Treatment1 Intervention
Part 2: VP-315 once-daily dosing; total daily dose of 8 mg in up to 5 cohorts
Cohort 1: VP-315 once-daily dosing of 8 mg with half the target dose of 8 mg only on W1D1; all remaining doses will be the full target dose
Cohort 2: VP-315 once-daily dosing of 8 mg on all treatment days for up to 3 consecutive daily doses/week.
Cohort 3: has been removed, advance from Cohort 2 to 4 and 5.
Cohorts 4 and 5, the total daily dose of VP-315 (8.0 mg) will be divided into a split dose; the first dose is not to exceed 2.4 mg (30% of 8 mg dose), and the remaining dose will not exceed 5.6 mg (70% of 8 mg dose) and administered 15 minutes apart (not to exceed 30 minutes).
Cohort 4: (Two times weekly dosing) VP-315 once-daily dosing of 8 mg, administered on 2 consecutive days in one week.
Cohort 5: (Three times weekly dosing) VP-315 once-daily dosing of 8 mg, administered on 3 consecutive days in one week.
PK data will be collected in the Cohorts 4 and 5 expansion groups.
Group II: Part 1 LTX-315 Safety Run-inExperimental Treatment1 Intervention
Part 1: Starting total daily dose of LTX-315 will be 2 mg for the first subject. Subjects will receive ascending once daily doses increasing in 1 mg increments for up to 3 days in a 7-day treatment week until the first lesion is necrosed or a DLT occurs
Find a Location
Who is running the clinical trial?
Verrica Pharmaceuticals Inc.Lead Sponsor
5 Previous Clinical Trials
722 Total Patients Enrolled
MyonexUNKNOWN
Vial Health Technology, IncUNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My lesion is between 0.5 cm and 2 cm in size before a biopsy.Your kidney function and tryptase level in your blood are not within normal range.I have a genetic condition like Gorlin syndrome or xeroderma pigmentosum.I will use effective birth control during and 4 weeks after the study.I am willing to avoid direct sunlight and tanning parlors during the study.I am willing to have surgery for my basal cell carcinoma after the study treatment.My biopsy shows I have a specific type of skin cancer.My lesions are near sensitive areas like eyes, lips, or on hands, feet, ears, nose, and genitals.I haven't used certain skin treatments or had skin surgery near my BCC lesion recently.I agree not to use unapproved creams near my BCC lesion during treatment.My biopsy confirms I have a specific type of skin cancer.My cancer has come back or was treated before.I am 18 years old or older.You are currently using alcohol or drugs excessively.I have not had and do not plan any elective surgery around the study period.I have 1 to 5 skin lesions suspected to be basal cell carcinoma, suitable for removal.My skin cancer is considered medium or high risk.My biopsy shows signs of another type of tumor.I haven't taken any immune system treatments in the last 12 weeks.I have or might have cancer that has spread in my body.I haven't had chemotherapy in the last 6 months.I am not pregnant or breastfeeding.My skin cancer is not located on my lower legs.I agree to wait for surgery on my skin cancer spots until after my treatment ends.
Research Study Groups:
This trial has the following groups:- Group 1: Part 2 VP-315 Regimen Finding
- Group 2: Part 1 LTX-315 Safety Run-in
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.
Are there currently any vacancies for participants in this clinical experiment?
"Affirmative. Information available on clinicaltrials.gov states that this medical trial is presently seeking participants, with the first posting taking place on February 1st 2022 and last edited September 12th of the same year. Sixty-six individuals are needed from three separate sites for participation in the study."
Answered by AI
What previous explorations have been made into the efficacy of LTX-315 Part 3?
"Presently, 3 studies for LTX-315 Part 3 are open with 0 Phase 3 trials. Though many of the research centers offering these services are located in Rockville, Maryland, a total of 9 sites have been gathering data on this project."
Answered by AI
Has the regulatory agency sanctioned LTX-315 Part 3?
"There is early evidence that LTX-315 Part 3 may be safe, thus the score of 2. This clinical trial is only in phase 2 which implies a lack of efficacy data."
Answered by AI
What is the scale of participation in this clinical experiment?
"To meet the study's requirements, 66 patients who fit all of its criteria must take part in this trial. Those interested can join at any one of several locations including Therapeutics Clinical Research in San Diego and Florida Center for Dermatology in Saint Augustine."
Answered by AI
What are the core aims of this experiment?
"As reported by the trial sponsor, Verrica Pharmaceuticals Inc., the primary outcome to be measured over 42 days is the percentage of patients that experience a complete response at excision. Secondary outcomes include abscopal effect assessment, cutaneous reaction severity rating, and physician-rated global assessments while tracking progress or regression."
Answered by AI
Does this trial offer a unique approach that has not been tested before?
"Since 2018, Lytix Biopharma AS has been researching the effects of LTX-315 Part 3. The initial trial in that year involved 6 people and subsequently led to Phase 2 drug approval. Presently, 5 cities across different nations are hosting three active clinical studies for this medication."
Answered by AI
Who else is applying?
What site did they apply to?
Gwinnett Dermatology
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
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