Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Carcinoma

Carcinoma, Basal Cell

Skin Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Basal Cell

Skin Diseases

Part 1: Starting total daily dose of LTX-315 will be 2 mg for the first subject. Subjects will receive ascending once daily doses increasing in 1 mg increments for up to 3 days in a 7-day treatment week until the first lesion is necrosed or a DLT occurs

Part 2: VP-315 once-daily dosing; total daily dose of 8 mg in up to 5 cohorts

* Cohort 1: VP-315 once-daily dosing of 8 mg with half the target dose of 8 mg only on W1D1; all remaining doses will be the full target dose
* Cohort 2: VP-315 once-daily dosing of 8 mg on all treatment days for up to 3 consecutive daily doses/week.
* Cohort 3: has been removed, advance from Cohort 2 to 4 and 5.

Cohorts 4 and 5, the total daily dose of VP-315 (8.0 mg) will be divided into a split dose; the first dose is not to exceed 2.4 mg (30% of 8 mg dose), and the remaining dose will not exceed 5.6 mg (70% of 8 mg dose) and administered 15 minutes apart (not to exceed 30 minutes).

* Cohort 4: (Two times weekly dosing) VP-315 once-daily dosing of 8 mg, administered on 2 consecutive days in one week.
* Cohort 5: (Three times weekly dosing) VP-315 once-daily dosing of 8 mg, administered on 3 consecutive days in one week.

PK data will be collected in the Cohorts 4 and 5 expansion groups.

LTX-315 once-daily dosing; starting total daily dose of 2 mg for the first subject. Ascending once-daily 1 mg dosing increments (eg, 2 mg on Day 1, 3 mg on Day 2). Subjects may be treated for a maximum of 2 weeks and a maximum total daily dose of 8 mg in Part 1. The starting dose will be escalated between subject cohorts in 1-mg increments after the previous cohort has completed Week 1 dosing (the DLT observation period).

LTX-315 Part 1

VP-315 once-daily dosing; Part 2 will be initiated upon completion of Part 1 to determine the optimal dosing regimen of VP-315. There were no DLTs observed in Part 1 of the study and the maximum dose of 8 mg was achieved. Therefore, the dose to be evaluated in Part 2 will be a total daily dose of 8 mg in 4 Cohorts.

VP-315 Part 2

Wendy Pinson

Neal D Bhatia, MD

Jonathan Kantor, MD

Jonathan S Weiss, MD

Daniel Carrasco, MD

Edward Lain, MD

Neal Bhatia, MD

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 80 subjects with a histological diagnosis of BCC in at least 1 eligible target lesion (confirmed by punch or shave biopsy).

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 80 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).

This is an open-label, multicenter, dose-escalating study. Eligible subjects will be enrolled sequentially.

Open-Label Proof of Concept Study of VP-315 in Basal Cell Carcinoma

A Phase 2, Multicenter, Open-label, Proof-of-concept Study With Safety Run-in to Evaluate the Safety, Pharmacokinetics, and Efficacy of VP-315 in Adult Subjects With Basal Cell Carcinoma

Subjects who discontinued the study due to adverse event

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)

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 that discontinued study due to adverse events

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)

Clinical clearance of treated lesion at excision as determined by visual assessment (no residual tumor seen on visual inspection)

Subjects with histological clearance of treated lesion(s) at excision

Abscopal effect as determined by clinical and histological clearance of nontreated lesions at excision

Estimate of remaining tumor volume (necrotic cells:tumor cells) at excision

Physician's global assessment of improvement per lesion as measured by the following scale: 100% improvement, no visible tumor; 75% to \<100% improvement; 50% to \<75% improvement; 25% to \<50% improvement; up to 25% improvement; no change; worse

Pharmacokinetics (PK) of an 8 mg dose of VP-315 administered with the optimal dosing regimen

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Open-Label Proof of Concept Study of VP-315 in Basal Cell Carcinoma	NCT05188729	Basal Cell Carc... Skin Cancer Cancer of the S... Cancer of the S... Carcinoma	LTX-315 Part 1 VP-315 Part 2	18 Years -	Verrica Pharmaceuticals Inc.
Open-Label Proof of Concept Study of VP-315 in Basal Cell Carcinoma	NCT05188729	Basal Cell Carc... Skin Cancer Cancer of the S... Cancer of the S... Carcinoma	LTX-315 Part 1 VP-315 Part 2	18 Years -	Verrica Pharmaceuticals Inc.

Spots Global Cancer Trial Database for cancer of the skin, basal cell