Basal Cell Carcinoma, Cancer of the Skin, Cancer of the Skin, Basal Cell, Carcinoma, Skin Cancer
Conditions
Keywords
Skin Cancer, BCC, Neoplasm, Epithelial
Brief summary
This is a 2-part, open-label, multicenter, dose-escalation, proof-of-concept study with a safety run-in designed to assess the safety, tolerability, MTD, and objective antitumor efficacy of ascending dose strengths of VP-315 when administered intratumorally to adults with biopsy proven basal cell carcinoma (BCC). The study is expected to enroll approximately 86 subjects with a histological diagnosis of BCC in at least 1 eligible target lesion (confirmed by punch or shave biopsy).
Detailed description
This is a 2-part, open-label, multicenter, dose-escalation, proof-of-concept study with a safety run-in designed to assess the safety, tolerability, maximum tolerated dose (MTD), and objective antitumor efficacy of ascending dose strengths of VP-315 when administered intratumorally to adults with biopsy proven BCC. The study is expected to enroll approximately 86 subjects with a histological diagnosis of BCC in at least 1 eligible target lesion (confirmed by punch or shave biopsy). All enrolled subjects will receive VP-315 intradermal injection on an outpatient basis into up to 2 target lesions. In all Parts of the study (1 or 2, as below), each 7-day treatment week comprises up to 3 consecutive treatment days followed by a no-treatment period of at least 4 days. Dosing will commence in a single target lesion. Once a lesion is observed to be fully necrotic (Part 1, Part 2; Cohorts 1-2 only), treatment of that lesion stops, and treatment of subsequent target lesions (up to 2 total) may continue on Day 1 of the following week. In Part 2, Cohorts 4 and 5, treatment of a second target lesion begins on W2D1 (not based on status of necrosis of target lesion 1).
Interventions
DRUGPart 1: VP-315 3 Day Dosing/Week
2-8 mg of VP-315 administered via intratumor injection into a single target lesion on W1D1. Each 500-μL dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. In all parts of the study, the targeted total volume of delivery is 500 μL daily.
DRUGPart 2: VP-315 3 Day Dosing/Week - Loading Dose
4mg (halt the target dose) loading dose on W1D1 administered via intratumor injection into a single target lesion, followed by total daily doses at the full target dose of 8 mg on the remaining days of treatment.
DRUGPart 2: VP-315 3 Day Dosing/Week - No Loading Dose
8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 3 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
DRUGPart 2: VP-315 2 Day Dosing/Week - Split Dose
8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 2 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
DRUGPart 2: VP-315 3 Day Dosing/Week - Split Dose
8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 3 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
Sponsors
Instat Clinical Research
HeartcoR Solutions
Myonex
Vial Health Technology, Inc
OncoBay Clinical
Q2 Solutions
Canfield Scientific
Veristat
Verrica Pharmaceuticals Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is an open-label, multicenter, dose-escalating study. Eligible subjects will be enrolled sequentially.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults ≥18 years of age 2. Clinically suspected BCC with at least 1 and up to 5 eligible lesion(s) suitable for biopsy and excision 3. Willing to refrain from using nonapproved topical agents on, or within 2 cm of, the target BCC lesions and surrounding areas during the treatment period. Subjects should use topical agents that are gentle (eg, Aquaphor, CeraVe) and will not irritate the skin in these areas. 4. Willing to refrain from exposure to direct sunlight or ultraviolet light and to avoid the use of tanning parlors for the duration of the study 5. Written informed consent obtained, including consent for tissue to be examined by the central dermatopathologist and stored by the Sponsor or designee 6. Willing to undergo BCC surgical excision procedure of target and nontarget BCC lesions after study treatment 7. Willing to delay surgical excision of target and nontarget BCC lesions until the end of treatment (EOT) visit 8. Provides written consent to allow photographs of the target and nontarget BCC lesion to be used as part of the study data 9. 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. BCC Lesion Eligibility Eligible lesions are those that meet the BCC lesion eligibility specifications described herein, from samples that are either from: * HISTORICAL punch or shave biopsies (i.e., samples collected according to clinical standard of care collected within the 90 days prior to W1D1); * A 2-mm punch biopsy collected within 90 days of W1D1 for suspected BCC ≥0.5 cm to 1.0 cm, and 3-mm punch biopsy for suspected BCC \>1.0 cm to 2.0 cm; or * A shave biopsy performed according to standard of care to include superficial or middle papillary dermis collected within 90 days of W1D1. Lesions must meet the following criteria to be eligible for treatment BCC Lesion Inclusion Criteria 1. 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. 2. Histological diagnosis of nodular, micronodular, or superficial BCC, as confirmed by punch or shave biopsy performed within 90 days of W1D1. (NOTE: HISTORICAL punch or shave biopsies are acceptable, provided that the biopsy was performed according to clinical standard of care and was collected within the 90 days prior to Screening.) Subject
Exclusion criteria
Subjects who meet any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Up to 105 days | Evaluation of the tissue condition at the treatment site for the presence and severity of each of the following cutaneous reactions; Erythema, Induration, Swelling, Blister Formation, Desquamation, Erosion, Ulceration, Necrosis by a scale of None; Mild; Moderate; Severe. Subjects having more than one event may appear in more than one SOC or PT but are counted at most once per each SOC and PT at the maximum severity. Cutaneous injection site reactions are types of reactions that can be expected to occur. The intended scale for cutaneous injection site reactions is mild, moderate, severe from CRA |
| Part 1: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Up to 9 weeks | Cutaneous injection site reactions are defined as the following preferred terms: Injection site erythema, Injection site induration, Injection site swelling, Injection site vesicles, Injection site exfoliation, Injection site erosion, Injection site ulcer, Injection site necrosis. The intended scale for cutaneous injection site reactions is mild, moderate, severe from CRA. Subjects having more than one event may appear in more than one System Organ Class or Preferred Term but are counted at most once per each SOC and PT at the maximum severity. Cutaneous injection site reactions are types of reactions that can be expected to occur. |
| Part 2: Percent of Subjects With Adverse Events | Up to 15 weeks | Part 2: Percent of subjects with adverse events, treatment-related AEs |
| Part 2: Percentage of Subjects With Study Discontinuations Due to Adverse Events | Up to 15 weeks | Part 2: Percentage of subjects with study discontinuations due to adverse events. |
| Part 2: Percent of Subjects With Treatment Related Adverse Events of Special Interest (TRAEs SI) | Treatment Days up to 2 weeks | Subjects with pre-determined TRAEs of SI such as hypotension (specific criteria); significant elevation of serum tryptase; Grade 2 or higher adverse event (with specific criteria) |
| Part 1: Percentage of Subjects With Discontinuations Due to Adverse Events | Up to 9 weeks | Part 1: Percentage of subjects that discontinued the study due to adverse event |
| Part 1: Percentage of Subjects With Dose-limiting Toxicities (DLTs) | Day 4 (Safety Assessment) | Subjects with pre-determined dose-limiting toxicities such as hypotension (specific criteria); significant elevation of serum tryptase; Grade 2 or higher adverse event (with specific criteria) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision | Day 84-91 | Percentage of Subjects with histological clearance of treated lesion(s) at excision. Histologic clearance confirmed by central dermatopathologist. Percentage is calculated using the number of subjects with non-missing responses within lesion as the denominator. \*Scar indicates complete histologic clearance |
| Part 2: Mean Estimated Remaining Tumor Volume at Excision | Day 84-91 | Estimate of remaining tumor volume (necrotic cells:tumor cells) at excision by central dermatopathologist Scale: 0 = None Remaining to 100 = All Remaining. |
| Part 2 (Cohorts 4 and 5 Expansion Groups): Plasma Concentrations of VP-315 | Day 1-2 | Pharmacokinetics (PK) of an 8 mg dose of VP-315 administered with the optimal dosing regimen |
| Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Day 84-91 | Clinical clearance of Target Lesion at excision as determined by visual assessment (no residual tumor seen on visual inspection). Clinical assessment using Physician Global Assessment (PGA). PGA scale: 100% Improvement, no visible tumor; 75% to less than 100% improvement, 50% to less than 75% improvement, 25% to less than 50% improvement, Up to 25% improvement, No change, Worse. |
Countries
United States
Participant flow
Recruitment details
Recruitment Details Study participants were recruited from one of the clinical trial sites selected to participate in the trial that met the study criteria and expressed interest in participating in a BCC trial. Up to 2 Target Lesions for treatment could be enrolled for each participant.
Participants by arm
| Arm | Count |
|---|---|
| Part 1 - All Cohorts Cohorts 1-7: Starting total daily dose of VP-315 was 2-8 mg. Subjects will receive ascending once daily doses increasing in 1 mg increments for up to 3 days in a 7-day treatment week (e.g., 2 mg on Day 1, 3 mg on Day 2) until the first lesion is necrosed or a DLT occurs. Subjects may be treated for a maximum of 2 weeks and a maximum total daily dose of 8 mg.
Part 1: VP-315 3 Day Dosing/Week: 2-8 mg of VP-315 administered via intratumor injection into a single target lesion on W1D1. Each 500-μL dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. In all parts of the study, the targeted total volume of delivery is 500 μL daily. | 10 |
| Part 1 - All Cohorts Cohorts 1-7: Starting total daily dose of VP-315 was 2-8 mg. Subjects will receive ascending once daily doses increasing in 1 mg increments for up to 3 days in a 7-day treatment week (e.g., 2 mg on Day 1, 3 mg on Day 2) until the first lesion is necrosed or a DLT occurs. Subjects may be treated for a maximum of 2 weeks and a maximum total daily dose of 8 mg.
Part 1: VP-315 3 Day Dosing/Week: 2-8 mg of VP-315 administered via intratumor injection into a single target lesion on W1D1. Each 500-μL dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. In all parts of the study, the targeted total volume of delivery is 500 μL daily. | 12 |
| Part 2 - Cohort 1: Optimal Dosing Regimen of 3 Daily Doses of VP-315, 4 mg Loading Dose VP-315 once-daily dosing of 8 mg with a loading dose of half the target dose of 8 mg (i.e. 4 mg) only on W1D1; all remaining doses will be the full target dose without a loading dose. Subjects will be treated until the lesion is necrosed, for a maximum of 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
Part 2: VP-315 3 Day Dosing/Week - Loading Dose: 4mg (halt the target dose) loading dose on W1D1 administered via intratumor injection into a single target lesion, followed by total daily doses at the full target dose of 8 mg on the remaining days of treatment. | 6 |
| Part 2 - Cohort 1: Optimal Dosing Regimen of 3 Daily Doses of VP-315, 4 mg Loading Dose VP-315 once-daily dosing of 8 mg with a loading dose of half the target dose of 8 mg (i.e. 4 mg) only on W1D1; all remaining doses will be the full target dose without a loading dose. Subjects will be treated until the lesion is necrosed, for a maximum of 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
Part 2: VP-315 3 Day Dosing/Week - Loading Dose: 4mg (halt the target dose) loading dose on W1D1 administered via intratumor injection into a single target lesion, followed by total daily doses at the full target dose of 8 mg on the remaining days of treatment. | 7 |
| Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose VP-315 once-daily dosing of 8 mg on all treatment days (i.e., NO LOADING dose on W1D1) for up to 3 consecutive daily doses/week until the lesion is necrosed, for a maximum of 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
Part 2: VP-315 3 Day Dosing/Week - No Loading Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 3 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses). | 3 |
| Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose VP-315 once-daily dosing of 8 mg on all treatment days (i.e., NO LOADING dose on W1D1) for up to 3 consecutive daily doses/week until the lesion is necrosed, for a maximum of 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
Part 2: VP-315 3 Day Dosing/Week - No Loading Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 3 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses). | 3 |
| Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose) VP-315 once-daily dosing of 8 mg, administered on 2 consecutive days in one week (W1D1, W1D2). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second Target Lesion may begin on D1 of the next week (W2D1, W2D2). Each individual target lesion is treated for the assigned 2 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 4 total doses.
Part 2: VP-315 2 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 2 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses). | 10 |
| Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose) VP-315 once-daily dosing of 8 mg, administered on 2 consecutive days in one week (W1D1, W1D2). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second Target Lesion may begin on D1 of the next week (W2D1, W2D2). Each individual target lesion is treated for the assigned 2 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 4 total doses.
Part 2: VP-315 2 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 2 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses). | 11 |
| Part 2 - Cohort 4 Expansion Optimal Dosing VP-315 once-daily dosing of 8 mg, administered on 2 consecutive days in one week (W1D1, W1D2). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second Target Lesion may begin on D1 of the next week (W2D1, W2D2). Each individual target lesion is treated for the assigned 2 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 4 total doses.
Part 2: VP-315 2 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 2 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses). | 26 |
| Part 2 - Cohort 4 Expansion Optimal Dosing VP-315 once-daily dosing of 8 mg, administered on 2 consecutive days in one week (W1D1, W1D2). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second Target Lesion may begin on D1 of the next week (W2D1, W2D2). Each individual target lesion is treated for the assigned 2 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 4 total doses.
Part 2: VP-315 2 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 2 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses). | 31 |
| Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose) VP-315 once-daily dosing of 8 mg, administered on 3 consecutive days in one week (W1D1, W1D2, W1D3). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second target lesion may begin on D1 of the next week (W2D1, W2D2, W2D3). Each individual target lesion is treated for the assigned 3 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 6 total doses.
Part 2: VP-315 3 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 3 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses). | 10 |
| Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose) VP-315 once-daily dosing of 8 mg, administered on 3 consecutive days in one week (W1D1, W1D2, W1D3). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second target lesion may begin on D1 of the next week (W2D1, W2D2, W2D3). Each individual target lesion is treated for the assigned 3 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 6 total doses.
Part 2: VP-315 3 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 3 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses). | 12 |
| Part 2 - Cohort 5 Expansion: Optimal VP-315 once-daily dosing of 8 mg, administered on 3 consecutive days in one week (W1D1, W1D2, W1D3). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second target lesion may begin on D1 of the next week (W2D1, W2D2, W2D3). Each individual target lesion is treated for the assigned 3 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 6 total doses.
Part 2: VP-315 3 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 3 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses). | 27 |
| Part 2 - Cohort 5 Expansion: Optimal VP-315 once-daily dosing of 8 mg, administered on 3 consecutive days in one week (W1D1, W1D2, W1D3). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second target lesion may begin on D1 of the next week (W2D1, W2D2, W2D3). Each individual target lesion is treated for the assigned 3 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 6 total doses.
Part 2: VP-315 3 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 3 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses). | 34 |
| Total | 202 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Part 1 - All Cohorts | Part 2 - Cohort 5 Expansion: Optimal | Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose) | Part 2 - Cohort 4 Expansion Optimal Dosing | Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose) | Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose | Part 2 - Cohort 1: Optimal Dosing Regimen of 3 Daily Doses of VP-315, 4 mg Loading Dose | Total |
|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 63.4 years STANDARD_DEVIATION 7.97 | 64.2 years STANDARD_DEVIATION 9.35 | 68.3 years STANDARD_DEVIATION 10.59 | 66.3 years STANDARD_DEVIATION 9.22 | 60.4 years STANDARD_DEVIATION 10.09 | 65.0 years STANDARD_DEVIATION 6.08 | 63.7 years STANDARD_DEVIATION 13.82 | 64.7 years STANDARD_DEVIATION 9.57 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 26 Participants | 10 Participants | 25 Participants | 10 Participants | 3 Participants | 6 Participants | 90 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Fitzpatrick Skin Type I | 3 Participants | 5 Participants | 3 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 13 Participants |
| Fitzpatrick Skin Type II | 4 Participants | 17 Participants | 5 Participants | 20 Participants | 6 Participants | 3 Participants | 6 Participants | 61 Participants |
| Fitzpatrick Skin Type III | 3 Participants | 5 Participants | 2 Participants | 4 Participants | 3 Participants | 0 Participants | 0 Participants | 17 Participants |
| Fitzpatrick Skin Type IV | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Fitzpatrick Skin Type V | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Fitzpatrick Skin Type VI | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 10 Participants | 27 Participants | 10 Participants | 26 Participants | 9 Participants | 3 Participants | 6 Participants | 91 Participants |
| Region of Enrollment United States | 10 participants | 27 participants | 10 participants | 26 participants | 10 participants | 3 participants | 6 participants | 92 participants |
| Sex: Female, Male Female | 5 Participants | 11 Participants | 5 Participants | 16 Participants | 3 Participants | 1 Participants | 3 Participants | 44 Participants |
| Sex: Female, Male Male | 5 Participants | 16 Participants | 5 Participants | 10 Participants | 7 Participants | 2 Participants | 3 Participants | 48 Participants |
| Target Lesion 01 - Screening BCC Location Arm | 2 Target Lesions | 4 Target Lesions | 3 Target Lesions | 7 Target Lesions | 2 Target Lesions | 0 Target Lesions | 1 Target Lesions | 19 Target Lesions |
| Target Lesion 01 - Screening BCC Location Back | 5 Target Lesions | 9 Target Lesions | 3 Target Lesions | 4 Target Lesions | 3 Target Lesions | 0 Target Lesions | 4 Target Lesions | 28 Target Lesions |
| Target Lesion 01 - Screening BCC Location Buttock or Groin | 0 Target Lesions | 0 Target Lesions | 0 Target Lesions | 0 Target Lesions | 0 Target Lesions | 0 Target Lesions | 0 Target Lesions | 0 Target Lesions |
| Target Lesion 01 - Screening BCC Location Chest or Abdomen | 1 Target Lesions | 3 Target Lesions | 1 Target Lesions | 5 Target Lesions | 2 Target Lesions | 3 Target Lesions | 0 Target Lesions | 15 Target Lesions |
| Target Lesion 01 - Screening BCC Location Clavicle or Shoulder | 1 Target Lesions | 4 Target Lesions | 0 Target Lesions | 5 Target Lesions | 2 Target Lesions | 0 Target Lesions | 0 Target Lesions | 12 Target Lesions |
| Target Lesion 01 - Screening BCC Location Face or Neck | 1 Target Lesions | 4 Target Lesions | 1 Target Lesions | 4 Target Lesions | 1 Target Lesions | 0 Target Lesions | 0 Target Lesions | 11 Target Lesions |
| Target Lesion 01 - Screening BCC Location Leg or Foot | 0 Target Lesions | 3 Target Lesions | 2 Target Lesions | 1 Target Lesions | 0 Target Lesions | 0 Target Lesions | 1 Target Lesions | 7 Target Lesions |
| Target Lesion 01 - Screening Histologic Result Micronodular | 0 Target Lesions | 0 Target Lesions | 0 Target Lesions | 0 Target Lesions | 0 Target Lesions | 0 Target Lesions | 0 Target Lesions | 0 Target Lesions |
| Target Lesion 01 - Screening Histologic Result Nodular | 4 Target Lesions | 15 Target Lesions | 6 Target Lesions | 15 Target Lesions | 4 Target Lesions | 0 Target Lesions | 1 Target Lesions | 45 Target Lesions |
| Target Lesion 01 - Screening Histologic Result Superficial | 6 Target Lesions | 12 Target Lesions | 4 Target Lesions | 11 Target Lesions | 6 Target Lesions | 3 Target Lesions | 5 Target Lesions | 47 Target Lesions |
| Target Lesion 02 - Screening BCC Location Arm | 0 Target Lesions | 0 Target Lesions | 1 Target Lesions | 1 Target Lesions | 1 Target Lesions | 0 Target Lesions | 0 Target Lesions | 3 Target Lesions |
| Target Lesion 02 - Screening BCC Location Back | 1 Target Lesions | 2 Target Lesions | 0 Target Lesions | 0 Target Lesions | 0 Target Lesions | 0 Target Lesions | 1 Target Lesions | 4 Target Lesions |
| Target Lesion 02 - Screening BCC Location Buttocks or Groin | 0 Target Lesions | 0 Target Lesions | 0 Target Lesions | 0 Target Lesions | 0 Target Lesions | 0 Target Lesions | 0 Target Lesions | 0 Target Lesions |
| Target Lesion 02 - Screening BCC Location Chest or Abdomen | 0 Target Lesions | 3 Target Lesions | 0 Target Lesions | 2 Target Lesions | 0 Target Lesions | 0 Target Lesions | 0 Target Lesions | 5 Target Lesions |
| Target Lesion 02 - Screening BCC Location Clavicle or Shoulder | 1 Target Lesions | 1 Target Lesions | 1 Target Lesions | 2 Target Lesions | 0 Target Lesions | 0 Target Lesions | 0 Target Lesions | 5 Target Lesions |
| Target Lesion 02 - Screening BCC Location Face or Neck | 0 Target Lesions | 1 Target Lesions | 0 Target Lesions | 0 Target Lesions | 0 Target Lesions | 0 Target Lesions | 0 Target Lesions | 1 Target Lesions |
| Target Lesion 02 - Screening BCC Location Leg or Foot | 0 Target Lesions | 0 Target Lesions | 0 Target Lesions | 0 Target Lesions | 0 Target Lesions | 0 Target Lesions | 0 Target Lesions | 0 Target Lesions |
| Target Lesion 02 - Screening Histologic Result Micronodular | 0 Target Lesions | 0 Target Lesions | 0 Target Lesions | 0 Target Lesions | 0 Target Lesions | 0 Target Lesions | 0 Target Lesions | 0 Target Lesions |
| Target Lesion 02 - Screening Histologic Result Nodular | 2 Target Lesions | 3 Target Lesions | 1 Target Lesions | 1 Target Lesions | 1 Target Lesions | 0 Target Lesions | 0 Target Lesions | 8 Target Lesions |
| Target Lesion 02 - Screening Histologic Result Superficial | 0 Target Lesions | 4 Target Lesions | 1 Target Lesions | 4 Target Lesions | 0 Target Lesions | 0 Target Lesions | 1 Target Lesions | 10 Target Lesions |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 6 | 0 / 3 | 0 / 10 | 0 / 26 | 0 / 10 | 0 / 27 |
| other Total, other adverse events | 10 / 10 | 6 / 6 | 3 / 3 | 10 / 10 | 26 / 26 | 10 / 10 | 27 / 27 |
| serious Total, serious adverse events | 0 / 10 | 0 / 6 | 0 / 3 | 1 / 10 | 0 / 26 | 0 / 10 | 0 / 27 |
Outcome results
Primary
Part 1: Percentage of Subjects With Cutaneous Reaction by Maximum Severity
Cutaneous injection site reactions are defined as the following preferred terms: Injection site erythema, Injection site induration, Injection site swelling, Injection site vesicles, Injection site exfoliation, Injection site erosion, Injection site ulcer, Injection site necrosis. The intended scale for cutaneous injection site reactions is mild, moderate, severe from CRA. Subjects having more than one event may appear in more than one System Organ Class or Preferred Term but are counted at most once per each SOC and PT at the maximum severity. Cutaneous injection site reactions are types of reactions that can be expected to occur.
Time frame: Up to 9 weeks
Population: Safety Population. Due to the small number of subjects in each Cohort for Part 1, data for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1 - All Cohorts | Part 1: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Necrosis: Moderate | 4 Participants |
| Part 1 - All Cohorts | Part 1: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Ulcer: Mild | 3 Participants |
| Part 1 - All Cohorts | Part 1: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Vesicles: Severe | 0 Participants |
| Part 1 - All Cohorts | Part 1: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Erythema: Mild | 1 Participants |
| Part 1 - All Cohorts | Part 1: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Erythema: Moderate | 6 Participants |
| Part 1 - All Cohorts | Part 1: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Erythema: Severe | 0 Participants |
| Part 1 - All Cohorts | Part 1: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Induration: Mild | 4 Participants |
| Part 1 - All Cohorts | Part 1: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Induration: Moderate | 4 Participants |
| Part 1 - All Cohorts | Part 1: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Induration: Severe | 0 Participants |
| Part 1 - All Cohorts | Part 1: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Necrosis: Mild | 0 Participants |
| Part 1 - All Cohorts | Part 1: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Necrosis: Severe | 3 Participants |
| Part 1 - All Cohorts | Part 1: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Swelling: Mild | 4 Participants |
| Part 1 - All Cohorts | Part 1: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Swelling: Moderate | 3 Participants |
| Part 1 - All Cohorts | Part 1: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Swelling: Severe | 0 Participants |
| Part 1 - All Cohorts | Part 1: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Erosion: Mild | 2 Participants |
| Part 1 - All Cohorts | Part 1: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Erosion: Moderate | 4 Participants |
| Part 1 - All Cohorts | Part 1: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Erosion: Severe | 0 Participants |
| Part 1 - All Cohorts | Part 1: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Exfoliation: Mild | 3 Participants |
| Part 1 - All Cohorts | Part 1: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Exfoliation: Moderate | 4 Participants |
| Part 1 - All Cohorts | Part 1: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Exfoliation: Severe | 0 Participants |
| Part 1 - All Cohorts | Part 1: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Ulcer: Moderate | 1 Participants |
| Part 1 - All Cohorts | Part 1: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Ulcer: Severe | 1 Participants |
| Part 1 - All Cohorts | Part 1: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Vesicles: Mild | 2 Participants |
| Part 1 - All Cohorts | Part 1: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Vesicles: Moderate | 1 Participants |
Primary
Part 1: Percentage of Subjects With Discontinuations Due to Adverse Events
Part 1: Percentage of subjects that discontinued the study due to adverse event
Time frame: Up to 9 weeks
Population: Part 1 - Enrolled Subjects. Due to the small number of subjects in each Cohort for Part 1, data for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1 - All Cohorts | Part 1: Percentage of Subjects With Discontinuations Due to Adverse Events | 0 Participants |
Primary
Part 1: Percentage of Subjects With Dose-limiting Toxicities (DLTs)
Subjects with pre-determined dose-limiting toxicities such as hypotension (specific criteria); significant elevation of serum tryptase; Grade 2 or higher adverse event (with specific criteria)
Time frame: Day 4 (Safety Assessment)
Population: Safety Population - Part 1 only. Due to the small number of subjects in each Cohort for Part 1, data for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1 - All Cohorts | Part 1: Percentage of Subjects With Dose-limiting Toxicities (DLTs) | 1 Participants |
Primary
Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity
Evaluation of the tissue condition at the treatment site for the presence and severity of each of the following cutaneous reactions; Erythema, Induration, Swelling, Blister Formation, Desquamation, Erosion, Ulceration, Necrosis by a scale of None; Mild; Moderate; Severe. Subjects having more than one event may appear in more than one SOC or PT but are counted at most once per each SOC and PT at the maximum severity. Cutaneous injection site reactions are types of reactions that can be expected to occur. The intended scale for cutaneous injection site reactions is mild, moderate, severe from CRA
Time frame: Up to 105 days
Population: Safety Population
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Part 1 - All Cohorts | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Exfoliation | Mild | 1 Participants |
| Part 1 - All Cohorts | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Swelling | Moderate | 0 Participants |
| Part 1 - All Cohorts | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Swelling | Not applicable | 3 Participants |
| Part 1 - All Cohorts | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Erosion | Not applicable | 5 Participants |
| Part 1 - All Cohorts | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Swelling | Severe | 0 Participants |
| Part 1 - All Cohorts | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Erythema | Not applicable | 0 Participants |
| Part 1 - All Cohorts | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Erosion | Moderate | 0 Participants |
| Part 1 - All Cohorts | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Induration | Mild | 4 Participants |
| Part 1 - All Cohorts | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Erosion | Mild | 1 Participants |
| Part 1 - All Cohorts | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Erosion | Severe | 0 Participants |
| Part 1 - All Cohorts | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Erythema | Mild | 5 Participants |
| Part 1 - All Cohorts | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Vesicles | Not applicable | 6 Participants |
| Part 1 - All Cohorts | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Induration | Moderate | 1 Participants |
| Part 1 - All Cohorts | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Necrosis | Severe | 4 Participants |
| Part 1 - All Cohorts | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Vesicles | Severe | 0 Participants |
| Part 1 - All Cohorts | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Induration | Severe | 0 Participants |
| Part 1 - All Cohorts | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Vesicles | Moderate | 0 Participants |
| Part 1 - All Cohorts | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Induration | Not applicable | 1 Participants |
| Part 1 - All Cohorts | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Vesicles | Mild | 0 Participants |
| Part 1 - All Cohorts | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Ulcer | Not applicable | 5 Participants |
| Part 1 - All Cohorts | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Necrosis | Mild | 0 Participants |
| Part 1 - All Cohorts | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Ulcer | Severe | 0 Participants |
| Part 1 - All Cohorts | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Necrosis | Moderate | 0 Participants |
| Part 1 - All Cohorts | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Erythema | Severe | 0 Participants |
| Part 1 - All Cohorts | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Ulcer | Moderate | 0 Participants |
| Part 1 - All Cohorts | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Ulcer | Mild | 1 Participants |
| Part 1 - All Cohorts | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Exfoliation | Not applicable | 5 Participants |
| Part 1 - All Cohorts | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Necrosis | Not applicable | 2 Participants |
| Part 1 - All Cohorts | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Exfoliation | Severe | 0 Participants |
| Part 1 - All Cohorts | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Exfoliation | Moderate | 0 Participants |
| Part 1 - All Cohorts | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Swelling | Mild | 3 Participants |
| Part 1 - All Cohorts | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Erythema | Moderate | 1 Participants |
| Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Exfoliation | Severe | 0 Participants |
| Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Swelling | Mild | 2 Participants |
| Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Swelling | Moderate | 0 Participants |
| Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Vesicles | Mild | 0 Participants |
| Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Ulcer | Mild | 0 Participants |
| Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Erosion | Severe | 0 Participants |
| Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Necrosis | Not applicable | 1 Participants |
| Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Erosion | Moderate | 0 Participants |
| Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Swelling | Severe | 0 Participants |
| Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Ulcer | Not applicable | 3 Participants |
| Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Necrosis | Severe | 0 Participants |
| Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Erosion | Mild | 1 Participants |
| Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Swelling | Not applicable | 1 Participants |
| Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Erythema | Moderate | 1 Participants |
| Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Necrosis | Mild | 0 Participants |
| Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Erythema | Not applicable | 0 Participants |
| Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Erythema | Severe | 0 Participants |
| Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Erosion | Not applicable | 2 Participants |
| Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Induration | Not applicable | 2 Participants |
| Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Erythema | Mild | 2 Participants |
| Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Exfoliation | Moderate | 0 Participants |
| Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Ulcer | Severe | 0 Participants |
| Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Vesicles | Not applicable | 3 Participants |
| Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Induration | Mild | 1 Participants |
| Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Exfoliation | Not applicable | 2 Participants |
| Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Ulcer | Moderate | 0 Participants |
| Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Induration | Moderate | 0 Participants |
| Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Exfoliation | Mild | 1 Participants |
| Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Vesicles | Severe | 0 Participants |
| Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Necrosis | Moderate | 2 Participants |
| Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Vesicles | Moderate | 0 Participants |
| Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Induration | Severe | 0 Participants |
| Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Erythema | Mild | 4 Participants |
| Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Induration | Not applicable | 2 Participants |
| Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Necrosis | Not applicable | 2 Participants |
| Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Erosion | Mild | 4 Participants |
| Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Erosion | Not applicable | 6 Participants |
| Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Ulcer | Not applicable | 7 Participants |
| Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Induration | Moderate | 3 Participants |
| Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Induration | Severe | 0 Participants |
| Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Necrosis | Mild | 1 Participants |
| Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Necrosis | Moderate | 5 Participants |
| Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Necrosis | Severe | 2 Participants |
| Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Swelling | Mild | 6 Participants |
| Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Swelling | Moderate | 3 Participants |
| Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Swelling | Severe | 0 Participants |
| Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Swelling | Not applicable | 1 Participants |
| Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Erosion | Moderate | 0 Participants |
| Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Erosion | Severe | 0 Participants |
| Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Exfoliation | Mild | 4 Participants |
| Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Exfoliation | Moderate | 0 Participants |
| Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Exfoliation | Severe | 0 Participants |
| Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Exfoliation | Not applicable | 6 Participants |
| Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Ulcer | Mild | 1 Participants |
| Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Ulcer | Moderate | 2 Participants |
| Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Ulcer | Severe | 0 Participants |
| Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Vesicles | Mild | 1 Participants |
| Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Vesicles | Moderate | 2 Participants |
| Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Vesicles | Severe | 0 Participants |
| Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Vesicles | Not applicable | 7 Participants |
| Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Erythema | Moderate | 6 Participants |
| Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Erythema | Severe | 0 Participants |
| Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Erythema | Not applicable | 0 Participants |
| Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Induration | Mild | 5 Participants |
| Part 2 - Cohort 4 Expansion Optimal Dosing | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Erosion | Not applicable | 18 Participants |
| Part 2 - Cohort 4 Expansion Optimal Dosing | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Swelling | Mild | 7 Participants |
| Part 2 - Cohort 4 Expansion Optimal Dosing | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Exfoliation | Mild | 5 Participants |
| Part 2 - Cohort 4 Expansion Optimal Dosing | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Exfoliation | Moderate | 2 Participants |
| Part 2 - Cohort 4 Expansion Optimal Dosing | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Necrosis | Not applicable | 7 Participants |
| Part 2 - Cohort 4 Expansion Optimal Dosing | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Exfoliation | Severe | 0 Participants |
| Part 2 - Cohort 4 Expansion Optimal Dosing | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Necrosis | Severe | 5 Participants |
| Part 2 - Cohort 4 Expansion Optimal Dosing | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Exfoliation | Not applicable | 19 Participants |
| Part 2 - Cohort 4 Expansion Optimal Dosing | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Erythema | Severe | 1 Participants |
| Part 2 - Cohort 4 Expansion Optimal Dosing | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Ulcer | Mild | 4 Participants |
| Part 2 - Cohort 4 Expansion Optimal Dosing | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Necrosis | Moderate | 9 Participants |
| Part 2 - Cohort 4 Expansion Optimal Dosing | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Ulcer | Moderate | 2 Participants |
| Part 2 - Cohort 4 Expansion Optimal Dosing | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Necrosis | Mild | 5 Participants |
| Part 2 - Cohort 4 Expansion Optimal Dosing | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Ulcer | Severe | 0 Participants |
| Part 2 - Cohort 4 Expansion Optimal Dosing | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Ulcer | Not applicable | 20 Participants |
| Part 2 - Cohort 4 Expansion Optimal Dosing | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Induration | Not applicable | 3 Participants |
| Part 2 - Cohort 4 Expansion Optimal Dosing | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Vesicles | Mild | 2 Participants |
| Part 2 - Cohort 4 Expansion Optimal Dosing | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Induration | Severe | 0 Participants |
| Part 2 - Cohort 4 Expansion Optimal Dosing | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Induration | Mild | 13 Participants |
| Part 2 - Cohort 4 Expansion Optimal Dosing | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Vesicles | Moderate | 0 Participants |
| Part 2 - Cohort 4 Expansion Optimal Dosing | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Induration | Moderate | 10 Participants |
| Part 2 - Cohort 4 Expansion Optimal Dosing | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Erythema | Not applicable | 2 Participants |
| Part 2 - Cohort 4 Expansion Optimal Dosing | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Vesicles | Severe | 0 Participants |
| Part 2 - Cohort 4 Expansion Optimal Dosing | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Vesicles | Not applicable | 24 Participants |
| Part 2 - Cohort 4 Expansion Optimal Dosing | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Erythema | Mild | 13 Participants |
| Part 2 - Cohort 4 Expansion Optimal Dosing | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Erosion | Moderate | 5 Participants |
| Part 2 - Cohort 4 Expansion Optimal Dosing | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Swelling | Not applicable | 11 Participants |
| Part 2 - Cohort 4 Expansion Optimal Dosing | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Erosion | Mild | 3 Participants |
| Part 2 - Cohort 4 Expansion Optimal Dosing | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Swelling | Severe | 0 Participants |
| Part 2 - Cohort 4 Expansion Optimal Dosing | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Erythema | Moderate | 10 Participants |
| Part 2 - Cohort 4 Expansion Optimal Dosing | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Erosion | Severe | 0 Participants |
| Part 2 - Cohort 4 Expansion Optimal Dosing | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Swelling | Moderate | 8 Participants |
| Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Exfoliation | Severe | 0 Participants |
| Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Ulcer | Moderate | 3 Participants |
| Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Necrosis | Mild | 2 Participants |
| Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Swelling | Severe | 1 Participants |
| Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Swelling | Moderate | 0 Participants |
| Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Ulcer | Severe | 0 Participants |
| Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Induration | Not applicable | 0 Participants |
| Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Ulcer | Not applicable | 2 Participants |
| Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Swelling | Not applicable | 2 Participants |
| Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Induration | Severe | 1 Participants |
| Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Vesicles | Mild | 0 Participants |
| Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Erythema | Moderate | 6 Participants |
| Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Erosion | Not applicable | 2 Participants |
| Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Vesicles | Moderate | 0 Participants |
| Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Induration | Moderate | 3 Participants |
| Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Erosion | Mild | 6 Participants |
| Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Erosion | Severe | 0 Participants |
| Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Vesicles | Severe | 0 Participants |
| Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Erythema | Not applicable | 0 Participants |
| Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Exfoliation | Mild | 3 Participants |
| Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Swelling | Mild | 7 Participants |
| Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Vesicles | Not applicable | 10 Participants |
| Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Exfoliation | Moderate | 1 Participants |
| Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Necrosis | Not applicable | 1 Participants |
| Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Necrosis | Severe | 0 Participants |
| Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Induration | Mild | 6 Participants |
| Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Erosion | Moderate | 2 Participants |
| Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Exfoliation | Not applicable | 6 Participants |
| Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Necrosis | Moderate | 7 Participants |
| Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Ulcer | Mild | 5 Participants |
| Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Erythema | Mild | 4 Participants |
| Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Erythema | Severe | 0 Participants |
| Part 2 - Cohort 5 Expansion: Optimal | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Exfoliation | Moderate | 3 Participants |
| Part 2 - Cohort 5 Expansion: Optimal | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Swelling | Mild | 11 Participants |
| Part 2 - Cohort 5 Expansion: Optimal | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Ulcer | Moderate | 4 Participants |
| Part 2 - Cohort 5 Expansion: Optimal | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Erosion | Not applicable | 13 Participants |
| Part 2 - Cohort 5 Expansion: Optimal | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Erythema | Moderate | 19 Participants |
| Part 2 - Cohort 5 Expansion: Optimal | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Erythema | Severe | 4 Participants |
| Part 2 - Cohort 5 Expansion: Optimal | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Erosion | Severe | 0 Participants |
| Part 2 - Cohort 5 Expansion: Optimal | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Erosion | Moderate | 6 Participants |
| Part 2 - Cohort 5 Expansion: Optimal | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Ulcer | Severe | 1 Participants |
| Part 2 - Cohort 5 Expansion: Optimal | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Induration | Not applicable | 1 Participants |
| Part 2 - Cohort 5 Expansion: Optimal | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Exfoliation | Mild | 9 Participants |
| Part 2 - Cohort 5 Expansion: Optimal | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Erythema | Not applicable | 1 Participants |
| Part 2 - Cohort 5 Expansion: Optimal | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Necrosis | Not applicable | 2 Participants |
| Part 2 - Cohort 5 Expansion: Optimal | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Ulcer | Not applicable | 18 Participants |
| Part 2 - Cohort 5 Expansion: Optimal | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Swelling | Moderate | 13 Participants |
| Part 2 - Cohort 5 Expansion: Optimal | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Induration | Severe | 1 Participants |
| Part 2 - Cohort 5 Expansion: Optimal | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Necrosis | Mild | 5 Participants |
| Part 2 - Cohort 5 Expansion: Optimal | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Swelling | Not applicable | 3 Participants |
| Part 2 - Cohort 5 Expansion: Optimal | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Exfoliation | Not applicable | 15 Participants |
| Part 2 - Cohort 5 Expansion: Optimal | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Vesicles | Mild | 3 Participants |
| Part 2 - Cohort 5 Expansion: Optimal | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Necrosis | Moderate | 7 Participants |
| Part 2 - Cohort 5 Expansion: Optimal | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Induration | Moderate | 16 Participants |
| Part 2 - Cohort 5 Expansion: Optimal | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Swelling | Severe | 0 Participants |
| Part 2 - Cohort 5 Expansion: Optimal | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Necrosis | Severe | 13 Participants |
| Part 2 - Cohort 5 Expansion: Optimal | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Vesicles | Not applicable | 20 Participants |
| Part 2 - Cohort 5 Expansion: Optimal | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Vesicles | Moderate | 4 Participants |
| Part 2 - Cohort 5 Expansion: Optimal | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Erythema | Mild | 3 Participants |
| Part 2 - Cohort 5 Expansion: Optimal | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Exfoliation | Severe | 0 Participants |
| Part 2 - Cohort 5 Expansion: Optimal | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Erosion | Mild | 8 Participants |
| Part 2 - Cohort 5 Expansion: Optimal | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Ulcer | Mild | 4 Participants |
| Part 2 - Cohort 5 Expansion: Optimal | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Vesicles | Severe | 0 Participants |
| Part 2 - Cohort 5 Expansion: Optimal | Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity | Induration | Mild | 9 Participants |
Primary
Part 2: Percentage of Subjects With Study Discontinuations Due to Adverse Events
Part 2: Percentage of subjects with study discontinuations due to adverse events.
Time frame: Up to 15 weeks
Population: Enrolled Subjects
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1 - All Cohorts | Part 2: Percentage of Subjects With Study Discontinuations Due to Adverse Events | 0 Participants |
| Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose | Part 2: Percentage of Subjects With Study Discontinuations Due to Adverse Events | 0 Participants |
| Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Study Discontinuations Due to Adverse Events | 0 Participants |
| Part 2 - Cohort 4 Expansion Optimal Dosing | Part 2: Percentage of Subjects With Study Discontinuations Due to Adverse Events | 0 Participants |
| Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Study Discontinuations Due to Adverse Events | 0 Participants |
| Part 2 - Cohort 5 Expansion: Optimal | Part 2: Percentage of Subjects With Study Discontinuations Due to Adverse Events | 0 Participants |
Primary
Part 2: Percent of Subjects With Adverse Events
Part 2: Percent of subjects with adverse events, treatment-related AEs
Time frame: Up to 15 weeks
Population: Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1 - All Cohorts | Part 2: Percent of Subjects With Adverse Events | 6 Participants |
| Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose | Part 2: Percent of Subjects With Adverse Events | 3 Participants |
| Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percent of Subjects With Adverse Events | 10 Participants |
| Part 2 - Cohort 4 Expansion Optimal Dosing | Part 2: Percent of Subjects With Adverse Events | 26 Participants |
| Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percent of Subjects With Adverse Events | 10 Participants |
| Part 2 - Cohort 5 Expansion: Optimal | Part 2: Percent of Subjects With Adverse Events | 25 Participants |
Primary
Part 2: Percent of Subjects With Treatment Related Adverse Events of Special Interest (TRAEs SI)
Subjects with pre-determined TRAEs of SI such as hypotension (specific criteria); significant elevation of serum tryptase; Grade 2 or higher adverse event (with specific criteria)
Time frame: Treatment Days up to 2 weeks
Population: Safety Population
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1 - All Cohorts | Part 2: Percent of Subjects With Treatment Related Adverse Events of Special Interest (TRAEs SI) | Blood Pressure Systolic Decreased | 0 Participants |
| Part 1 - All Cohorts | Part 2: Percent of Subjects With Treatment Related Adverse Events of Special Interest (TRAEs SI) | Hypotension | 0 Participants |
| Part 1 - All Cohorts | Part 2: Percent of Subjects With Treatment Related Adverse Events of Special Interest (TRAEs SI) | Injection Site Pain | 1 Participants |
| Part 1 - All Cohorts | Part 2: Percent of Subjects With Treatment Related Adverse Events of Special Interest (TRAEs SI) | Not applicable | 5 Participants |
| Part 1 - All Cohorts | Part 2: Percent of Subjects With Treatment Related Adverse Events of Special Interest (TRAEs SI) | Blood Pressure Diastolic Decreased | 0 Participants |
| Part 1 - All Cohorts | Part 2: Percent of Subjects With Treatment Related Adverse Events of Special Interest (TRAEs SI) | Urticaria | 0 Participants |
| Part 1 - All Cohorts | Part 2: Percent of Subjects With Treatment Related Adverse Events of Special Interest (TRAEs SI) | Injection Site Reaction | 0 Participants |
| Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose | Part 2: Percent of Subjects With Treatment Related Adverse Events of Special Interest (TRAEs SI) | Injection Site Reaction | 0 Participants |
| Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose | Part 2: Percent of Subjects With Treatment Related Adverse Events of Special Interest (TRAEs SI) | Blood Pressure Diastolic Decreased | 0 Participants |
| Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose | Part 2: Percent of Subjects With Treatment Related Adverse Events of Special Interest (TRAEs SI) | Injection Site Pain | 0 Participants |
| Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose | Part 2: Percent of Subjects With Treatment Related Adverse Events of Special Interest (TRAEs SI) | Hypotension | 0 Participants |
| Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose | Part 2: Percent of Subjects With Treatment Related Adverse Events of Special Interest (TRAEs SI) | Not applicable | 3 Participants |
| Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose | Part 2: Percent of Subjects With Treatment Related Adverse Events of Special Interest (TRAEs SI) | Blood Pressure Systolic Decreased | 0 Participants |
| Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose | Part 2: Percent of Subjects With Treatment Related Adverse Events of Special Interest (TRAEs SI) | Urticaria | 0 Participants |
| Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percent of Subjects With Treatment Related Adverse Events of Special Interest (TRAEs SI) | Injection Site Pain | 0 Participants |
| Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percent of Subjects With Treatment Related Adverse Events of Special Interest (TRAEs SI) | Hypotension | 0 Participants |
| Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percent of Subjects With Treatment Related Adverse Events of Special Interest (TRAEs SI) | Blood Pressure Diastolic Decreased | 0 Participants |
| Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percent of Subjects With Treatment Related Adverse Events of Special Interest (TRAEs SI) | Blood Pressure Systolic Decreased | 0 Participants |
| Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percent of Subjects With Treatment Related Adverse Events of Special Interest (TRAEs SI) | Injection Site Reaction | 0 Participants |
| Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percent of Subjects With Treatment Related Adverse Events of Special Interest (TRAEs SI) | Urticaria | 0 Participants |
| Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percent of Subjects With Treatment Related Adverse Events of Special Interest (TRAEs SI) | Not applicable | 10 Participants |
| Part 2 - Cohort 4 Expansion Optimal Dosing | Part 2: Percent of Subjects With Treatment Related Adverse Events of Special Interest (TRAEs SI) | Injection Site Reaction | 0 Participants |
| Part 2 - Cohort 4 Expansion Optimal Dosing | Part 2: Percent of Subjects With Treatment Related Adverse Events of Special Interest (TRAEs SI) | Urticaria | 0 Participants |
| Part 2 - Cohort 4 Expansion Optimal Dosing | Part 2: Percent of Subjects With Treatment Related Adverse Events of Special Interest (TRAEs SI) | Blood Pressure Diastolic Decreased | 2 Participants |
| Part 2 - Cohort 4 Expansion Optimal Dosing | Part 2: Percent of Subjects With Treatment Related Adverse Events of Special Interest (TRAEs SI) | Blood Pressure Systolic Decreased | 1 Participants |
| Part 2 - Cohort 4 Expansion Optimal Dosing | Part 2: Percent of Subjects With Treatment Related Adverse Events of Special Interest (TRAEs SI) | Hypotension | 1 Participants |
| Part 2 - Cohort 4 Expansion Optimal Dosing | Part 2: Percent of Subjects With Treatment Related Adverse Events of Special Interest (TRAEs SI) | Injection Site Pain | 0 Participants |
| Part 2 - Cohort 4 Expansion Optimal Dosing | Part 2: Percent of Subjects With Treatment Related Adverse Events of Special Interest (TRAEs SI) | Not applicable | 22 Participants |
| Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percent of Subjects With Treatment Related Adverse Events of Special Interest (TRAEs SI) | Injection Site Reaction | 1 Participants |
| Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percent of Subjects With Treatment Related Adverse Events of Special Interest (TRAEs SI) | Injection Site Pain | 0 Participants |
| Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percent of Subjects With Treatment Related Adverse Events of Special Interest (TRAEs SI) | Blood Pressure Diastolic Decreased | 0 Participants |
| Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percent of Subjects With Treatment Related Adverse Events of Special Interest (TRAEs SI) | Not applicable | 6 Participants |
| Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percent of Subjects With Treatment Related Adverse Events of Special Interest (TRAEs SI) | Urticaria | 1 Participants |
| Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percent of Subjects With Treatment Related Adverse Events of Special Interest (TRAEs SI) | Hypotension | 2 Participants |
| Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percent of Subjects With Treatment Related Adverse Events of Special Interest (TRAEs SI) | Blood Pressure Systolic Decreased | 0 Participants |
| Part 2 - Cohort 5 Expansion: Optimal | Part 2: Percent of Subjects With Treatment Related Adverse Events of Special Interest (TRAEs SI) | Urticaria | 0 Participants |
| Part 2 - Cohort 5 Expansion: Optimal | Part 2: Percent of Subjects With Treatment Related Adverse Events of Special Interest (TRAEs SI) | Injection Site Pain | 0 Participants |
| Part 2 - Cohort 5 Expansion: Optimal | Part 2: Percent of Subjects With Treatment Related Adverse Events of Special Interest (TRAEs SI) | Blood Pressure Diastolic Decreased | 0 Participants |
| Part 2 - Cohort 5 Expansion: Optimal | Part 2: Percent of Subjects With Treatment Related Adverse Events of Special Interest (TRAEs SI) | Hypotension | 1 Participants |
| Part 2 - Cohort 5 Expansion: Optimal | Part 2: Percent of Subjects With Treatment Related Adverse Events of Special Interest (TRAEs SI) | Not applicable | 26 Participants |
| Part 2 - Cohort 5 Expansion: Optimal | Part 2: Percent of Subjects With Treatment Related Adverse Events of Special Interest (TRAEs SI) | Injection Site Reaction | 0 Participants |
| Part 2 - Cohort 5 Expansion: Optimal | Part 2: Percent of Subjects With Treatment Related Adverse Events of Special Interest (TRAEs SI) | Blood Pressure Systolic Decreased | 0 Participants |
Secondary
Part 2 (Cohorts 4 and 5 Expansion Groups): Plasma Concentrations of VP-315
Pharmacokinetics (PK) of an 8 mg dose of VP-315 administered with the optimal dosing regimen
Time frame: Day 1-2
Population: PK Population - Part 2, Cohorts 4 Expansion and 5 Expansion subjects that consented to participate. Includes subjects in Safety Population with quantifiable PK concentration data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1 - All Cohorts | Part 2 (Cohorts 4 and 5 Expansion Groups): Plasma Concentrations of VP-315 | 32.1 h*ng/mL | Standard Deviation 2.95 |
| Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose | Part 2 (Cohorts 4 and 5 Expansion Groups): Plasma Concentrations of VP-315 | 29.4 h*ng/mL | Standard Deviation 13.78 |
Secondary
Part 2: Mean Estimated Remaining Tumor Volume at Excision
Estimate of remaining tumor volume (necrotic cells:tumor cells) at excision by central dermatopathologist Scale: 0 = None Remaining to 100 = All Remaining.
Time frame: Day 84-91
Population: Full Analysis Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1 - All Cohorts | Part 2: Mean Estimated Remaining Tumor Volume at Excision | Target Lesion 2 | 5.0 units on a scale | — |
| Part 1 - All Cohorts | Part 2: Mean Estimated Remaining Tumor Volume at Excision | Target Lesion 1 | 1.7 units on a scale | Standard Deviation 4.08 |
| Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose | Part 2: Mean Estimated Remaining Tumor Volume at Excision | Target Lesion 1 | 11.7 units on a scale | Standard Deviation 12.58 |
| Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Mean Estimated Remaining Tumor Volume at Excision | Target Lesion 1 | 11.1 units on a scale | Standard Deviation 19.49 |
| Part 2 - Cohort 4 Expansion Optimal Dosing | Part 2: Mean Estimated Remaining Tumor Volume at Excision | Target Lesion 1 | 14.8 units on a scale | Standard Deviation 22.1 |
| Part 2 - Cohort 4 Expansion Optimal Dosing | Part 2: Mean Estimated Remaining Tumor Volume at Excision | Target Lesion 2 | 6.3 units on a scale | Standard Deviation 9.46 |
| Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Mean Estimated Remaining Tumor Volume at Excision | Target Lesion 1 | 22.6 units on a scale | Standard Deviation 25.45 |
| Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Mean Estimated Remaining Tumor Volume at Excision | Target Lesion 2 | 7.5 units on a scale | Standard Deviation 10.61 |
| Part 2 - Cohort 5 Expansion: Optimal | Part 2: Mean Estimated Remaining Tumor Volume at Excision | Target Lesion 1 | 14.3 units on a scale | Standard Deviation 21 |
| Part 2 - Cohort 5 Expansion: Optimal | Part 2: Mean Estimated Remaining Tumor Volume at Excision | Target Lesion 2 | 13.3 units on a scale | Standard Deviation 27.87 |
Secondary
Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision
Clinical clearance of Target Lesion at excision as determined by visual assessment (no residual tumor seen on visual inspection). Clinical assessment using Physician Global Assessment (PGA). PGA scale: 100% Improvement, no visible tumor; 75% to less than 100% improvement, 50% to less than 75% improvement, 25% to less than 50% improvement, Up to 25% improvement, No change, Worse.
Time frame: Day 84-91
Population: Full Analysis Population. Participants with the Physician Global Assessment completed at the End of Treatment Visit. Report is based on Target Lesion 01 and Target Lesion 2 data in separate rows.
| Arm | Measure | Group | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|---|
| Part 1 - All Cohorts | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | 25% to less than 50% improvement | 0 Target Lesions |
| Part 1 - All Cohorts | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | No change | 0 Target Lesions |
| Part 1 - All Cohorts | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | 50% to less than 75% improvement | 0 Target Lesions |
| Part 1 - All Cohorts | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | No change | 1 Target Lesions |
| Part 1 - All Cohorts | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | Up to 25% improvement | 0 Target Lesions |
| Part 1 - All Cohorts | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | 50% to less than 75% improvement | 0 Target Lesions |
| Part 1 - All Cohorts | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | 75% to less than 100% improvement | 0 Target Lesions |
| Part 1 - All Cohorts | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | 25% to less than 50% improvement | 0 Target Lesions |
| Part 1 - All Cohorts | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | 100% Improvement, no visible tumor | 1 Target Lesions |
| Part 1 - All Cohorts | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | 100% Improvement, no visible tumor | 5 Target Lesions |
| Part 1 - All Cohorts | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | 75% to less than 100% improvement | 0 Target Lesions |
| Part 1 - All Cohorts | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | Worse | 0 Target Lesions |
| Part 1 - All Cohorts | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | Up to 25% improvement | 0 Target Lesions |
| Part 1 - All Cohorts | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | Worse | 0 Target Lesions |
| Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | Up to 25% improvement | 0 Target Lesions |
| Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | Worse | 0 Target Lesions |
| Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | No change | 1 Target Lesions |
| Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | Worse | 0 Target Lesions |
| Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | Up to 25% improvement | 0 Target Lesions |
| Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | 75% to less than 100% improvement | 1 Target Lesions |
| Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | 25% to less than 50% improvement | 0 Target Lesions |
| Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | 50% to less than 75% improvement | 0 Target Lesions |
| Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | 50% to less than 75% improvement | 0 Target Lesions |
| Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | No change | 0 Target Lesions |
| Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | 75% to less than 100% improvement | 0 Target Lesions |
| Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | 25% to less than 50% improvement | 0 Target Lesions |
| Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | 100% Improvement, no visible tumor | 0 Target Lesions |
| Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | 100% Improvement, no visible tumor | 1 Target Lesions |
| Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | 25% to less than 50% improvement | 0 Target Lesions |
| Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | 100% Improvement, no visible tumor | 6 Target Lesions |
| Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | 75% to less than 100% improvement | 3 Target Lesions |
| Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | 50% to less than 75% improvement | 0 Target Lesions |
| Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | 25% to less than 50% improvement | 0 Target Lesions |
| Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | Up to 25% improvement | 0 Target Lesions |
| Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | No change | 0 Target Lesions |
| Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | Worse | 0 Target Lesions |
| Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | 100% Improvement, no visible tumor | 0 Target Lesions |
| Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | 75% to less than 100% improvement | 0 Target Lesions |
| Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | 50% to less than 75% improvement | 0 Target Lesions |
| Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | Up to 25% improvement | 0 Target Lesions |
| Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | No change | 0 Target Lesions |
| Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | Worse | 0 Target Lesions |
| Part 2 - Cohort 4 Expansion Optimal Dosing | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | 100% Improvement, no visible tumor | 14 Target Lesions |
| Part 2 - Cohort 4 Expansion Optimal Dosing | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | Up to 25% improvement | 2 Target Lesions |
| Part 2 - Cohort 4 Expansion Optimal Dosing | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | 100% Improvement, no visible tumor | 4 Target Lesions |
| Part 2 - Cohort 4 Expansion Optimal Dosing | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | 75% to less than 100% improvement | 0 Target Lesions |
| Part 2 - Cohort 4 Expansion Optimal Dosing | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | 25% to less than 50% improvement | 0 Target Lesions |
| Part 2 - Cohort 4 Expansion Optimal Dosing | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | 50% to less than 75% improvement | 0 Target Lesions |
| Part 2 - Cohort 4 Expansion Optimal Dosing | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | 75% to less than 100% improvement | 2 Target Lesions |
| Part 2 - Cohort 4 Expansion Optimal Dosing | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | 50% to less than 75% improvement | 4 Target Lesions |
| Part 2 - Cohort 4 Expansion Optimal Dosing | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | 25% to less than 50% improvement | 0 Target Lesions |
| Part 2 - Cohort 4 Expansion Optimal Dosing | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | Up to 25% improvement | 0 Target Lesions |
| Part 2 - Cohort 4 Expansion Optimal Dosing | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | Worse | 0 Target Lesions |
| Part 2 - Cohort 4 Expansion Optimal Dosing | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | No change | 1 Target Lesions |
| Part 2 - Cohort 4 Expansion Optimal Dosing | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | No change | 3 Target Lesions |
| Part 2 - Cohort 4 Expansion Optimal Dosing | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | Worse | 0 Target Lesions |
| Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | Up to 25% improvement | 0 Target Lesions |
| Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | No change | 0 Target Lesions |
| Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | Up to 25% improvement | 0 Target Lesions |
| Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | No change | 0 Target Lesions |
| Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | 25% to less than 50% improvement | 0 Target Lesions |
| Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | 50% to less than 75% improvement | 1 Target Lesions |
| Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | 100% Improvement, no visible tumor | 1 Target Lesions |
| Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | 75% to less than 100% improvement | 2 Target Lesions |
| Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | 25% to less than 50% improvement | 2 Target Lesions |
| Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | 100% Improvement, no visible tumor | 5 Target Lesions |
| Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | Worse | 0 Target Lesions |
| Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | 75% to less than 100% improvement | 0 Target Lesions |
| Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | Worse | 0 Target Lesions |
| Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | 50% to less than 75% improvement | 0 Target Lesions |
| Part 2 - Cohort 5 Expansion: Optimal | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | No change | 1 Target Lesions |
| Part 2 - Cohort 5 Expansion: Optimal | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | Worse | 0 Target Lesions |
| Part 2 - Cohort 5 Expansion: Optimal | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | Up to 25% improvement | 1 Target Lesions |
| Part 2 - Cohort 5 Expansion: Optimal | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | 50% to less than 75% improvement | 0 Target Lesions |
| Part 2 - Cohort 5 Expansion: Optimal | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | 25% to less than 50% improvement | 0 Target Lesions |
| Part 2 - Cohort 5 Expansion: Optimal | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | 100% Improvement, no visible tumor | 19 Target Lesions |
| Part 2 - Cohort 5 Expansion: Optimal | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | 75% to less than 100% improvement | 4 Target Lesions |
| Part 2 - Cohort 5 Expansion: Optimal | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | Worse | 0 Target Lesions |
| Part 2 - Cohort 5 Expansion: Optimal | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | 25% to less than 50% improvement | 0 Target Lesions |
| Part 2 - Cohort 5 Expansion: Optimal | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | No change | 1 Target Lesions |
| Part 2 - Cohort 5 Expansion: Optimal | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | Up to 25% improvement | 0 Target Lesions |
| Part 2 - Cohort 5 Expansion: Optimal | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | 100% Improvement, no visible tumor | 5 Target Lesions |
| Part 2 - Cohort 5 Expansion: Optimal | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | 50% to less than 75% improvement | 0 Target Lesions |
| Part 2 - Cohort 5 Expansion: Optimal | Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | 75% to less than 100% improvement | 0 Target Lesions |
Secondary
Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision
Percentage of Subjects with histological clearance of treated lesion(s) at excision. Histologic clearance confirmed by central dermatopathologist. Percentage is calculated using the number of subjects with non-missing responses within lesion as the denominator. \*Scar indicates complete histologic clearance
Time frame: Day 84-91
Population: Full Analysis Population. Participants with Target Lesion(s) excised and histology confirmed by central dermatopathologist. Report is based on Target Lesion 01 and Target Lesion 2 data presented in separate rows. NOTE: All participants had a Target Lesion 1, however, not all participants had a Target Lesion 2, therefore, the numbers are not the same.
| Arm | Measure | Group | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|---|
| Part 1 - All Cohorts | Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | Focal Nodular | 0 Target Lesions |
| Part 1 - All Cohorts | Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | Nodular | 0 Target Lesions |
| Part 1 - All Cohorts | Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | Micronodular | 0 Target Lesions |
| Part 1 - All Cohorts | Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | Nodular | 0 Target Lesions |
| Part 1 - All Cohorts | Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | Superficial | 1 Target Lesions |
| Part 1 - All Cohorts | Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | Superficial Nodular | 0 Target Lesions |
| Part 1 - All Cohorts | Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | Scar (Complete histologic clearance) | 5 Target Lesions |
| Part 1 - All Cohorts | Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | Focal Nodular | 0 Target Lesions |
| Part 1 - All Cohorts | Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | Micronodular | 0 Target Lesions |
| Part 1 - All Cohorts | Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | Superficial | 0 Target Lesions |
| Part 1 - All Cohorts | Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | Superficial Nodular | 1 Target Lesions |
| Part 1 - All Cohorts | Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | Scar (Complete histologic clearance) | 0 Target Lesions |
| Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose | Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | Micronodular | 0 Target Lesions |
| Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose | Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | Superficial Nodular | 0 Target Lesions |
| Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose | Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | Nodular | 0 Target Lesions |
| Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose | Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | Scar (Complete histologic clearance) | 0 Target Lesions |
| Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose | Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | Superficial Nodular | 1 Target Lesions |
| Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose | Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | Focal Nodular | 0 Target Lesions |
| Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose | Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | Nodular | 1 Target Lesions |
| Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose | Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | Superficial | 0 Target Lesions |
| Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose | Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | Focal Nodular | 0 Target Lesions |
| Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose | Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | Superficial | 0 Target Lesions |
| Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose | Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | Scar (Complete histologic clearance) | 1 Target Lesions |
| Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose | Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | Micronodular | 0 Target Lesions |
| Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | Scar (Complete histologic clearance) | 5 Target Lesions |
| Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | Scar (Complete histologic clearance) | 0 Target Lesions |
| Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | Focal Nodular | 0 Target Lesions |
| Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | Superficial Nodular | 0 Target Lesions |
| Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | Focal Nodular | 0 Target Lesions |
| Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | Superficial | 0 Target Lesions |
| Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | Micronodular | 0 Target Lesions |
| Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | Superficial | 0 Target Lesions |
| Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | Superficial Nodular | 2 Target Lesions |
| Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | Nodular | 0 Target Lesions |
| Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | Micronodular | 0 Target Lesions |
| Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | Nodular | 2 Target Lesions |
| Part 2 - Cohort 4 Expansion Optimal Dosing | Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | Focal Nodular | 0 Target Lesions |
| Part 2 - Cohort 4 Expansion Optimal Dosing | Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | Superficial Nodular | 0 Target Lesions |
| Part 2 - Cohort 4 Expansion Optimal Dosing | Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | Nodular | 8 Target Lesions |
| Part 2 - Cohort 4 Expansion Optimal Dosing | Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | Superficial | 2 Target Lesions |
| Part 2 - Cohort 4 Expansion Optimal Dosing | Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | Superficial Nodular | 2 Target Lesions |
| Part 2 - Cohort 4 Expansion Optimal Dosing | Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | Scar (Complete histologic clearance) | 13 Target Lesions |
| Part 2 - Cohort 4 Expansion Optimal Dosing | Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | Micronodular | 0 Target Lesions |
| Part 2 - Cohort 4 Expansion Optimal Dosing | Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | Micronodular | 0 Target Lesions |
| Part 2 - Cohort 4 Expansion Optimal Dosing | Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | Nodular | 1 Target Lesions |
| Part 2 - Cohort 4 Expansion Optimal Dosing | Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | Scar (Complete histologic clearance) | 2 Target Lesions |
| Part 2 - Cohort 4 Expansion Optimal Dosing | Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | Superficial | 1 Target Lesions |
| Part 2 - Cohort 4 Expansion Optimal Dosing | Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | Focal Nodular | 0 Target Lesions |
| Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | Nodular | 1 Target Lesions |
| Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | Scar (Complete histologic clearance) | 1 Target Lesions |
| Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | Superficial Nodular | 4 Target Lesions |
| Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | Superficial | 1 Target Lesions |
| Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | Superficial Nodular | 1 Target Lesions |
| Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | Nodular | 0 Target Lesions |
| Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | Micronodular | 0 Target Lesions |
| Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | Focal Nodular | 0 Target Lesions |
| Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | Micronodular | 0 Target Lesions |
| Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | Superficial | 0 Target Lesions |
| Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | Scar (Complete histologic clearance) | 3 Target Lesions |
| Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose) | Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | Focal Nodular | 0 Target Lesions |
| Part 2 - Cohort 5 Expansion: Optimal | Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | Scar (Complete histologic clearance) | 3 Target Lesions |
| Part 2 - Cohort 5 Expansion: Optimal | Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | Micronodular | 0 Target Lesions |
| Part 2 - Cohort 5 Expansion: Optimal | Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | Superficial Nodular | 3 Target Lesions |
| Part 2 - Cohort 5 Expansion: Optimal | Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | Focal Nodular | 0 Target Lesions |
| Part 2 - Cohort 5 Expansion: Optimal | Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | Nodular | 2 Target Lesions |
| Part 2 - Cohort 5 Expansion: Optimal | Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | Superficial Nodular | 1 Target Lesions |
| Part 2 - Cohort 5 Expansion: Optimal | Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | Micronodular | 0 Target Lesions |
| Part 2 - Cohort 5 Expansion: Optimal | Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | Superficial | 0 Target Lesions |
| Part 2 - Cohort 5 Expansion: Optimal | Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | Superficial | 1 Target Lesions |
| Part 2 - Cohort 5 Expansion: Optimal | Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | Nodular | 7 Target Lesions |
| Part 2 - Cohort 5 Expansion: Optimal | Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision | Target Lesion 2 | Focal Nodular | 0 Target Lesions |
| Part 2 - Cohort 5 Expansion: Optimal | Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision | Target Lesion 1 | Scar (Complete histologic clearance) | 14 Target Lesions |