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

  • STATUS
    Recruiting
  • End date
    Sep 29, 2023
  • participants needed
    66
  • sponsor
    Verrica Pharmaceuticals Inc.
Updated on 15 October 2022
carcinoma

Summary

This is a 3-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 LTX 315 when administered intratumorally to adults with biopsy proven basal cell carcinoma (BCC).

The study is expected to enroll approximately 66 subjects with a histological diagnosis of BCC in at least 1 eligible target lesion (confirmed by punch or shave biopsy).

Description

This is a 3-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 LTX 315 when administered intratumorally to adults with biopsy proven BCC.

The study is expected to enroll approximately 66 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 LTX-315 intradermal injection on an outpatient basis into up to 2 target lesions. In all Parts of the study (1, 2, or 3, 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 has necrosed, treatment of that lesion stops, and treatment of subsequent target lesions (up to 2 total) may continue on Day 1 of the following week.

Details
Condition Basal Cell Carcinoma, Skin Cancer, Cancer of the Skin, Basal Cell, Cancer of the Skin
Treatment LTX-315 Part 1, LTX-315 Part 2, LTX-315 Part 3
Clinical Study IdentifierNCT05188729
SponsorVerrica Pharmaceuticals Inc.
Last Modified on15 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Adults ≥18 years of age
Clinically suspected BCC with at least 1 and up to 5 eligible lesion(s) suitable for biopsy and excision (see Section 5.4)
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
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
Written informed consent obtained, including consent for tissue to be examined by the central dermatopathologist and stored by the Sponsor or designee
Willing to undergo BCC surgical excision procedure of target and nontarget BCC lesions after study treatment
Willing to delay surgical excision of target and nontarget BCC lesions until the end of treatment (EOT) visit
Provides written consent to allow photographs of the target and nontarget BCC lesion to be used as part of the study data
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 Inclusion Criterion
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
Histological diagnosis of nodular, micronodular, or superficial BCC, as confirmed by punch or shave biopsy performed within 28 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 28 days prior to Screening.)

Exclusion Criteria

Presence of known or suspected systemic cancer
Treatment with systemic chemotherapeutic agents within the 6 months prior to the screening visit
Treatment with systemic immunotherapy, immunomodulators or immunosuppressants within the 12 weeks prior to the screening period
Genetic or nevoid conditions (eg, Gorlin / basal cell nevus syndrome, xeroderma pigmentosa)
Clinically significant laboratory values, as assessed by the investigator, for the tests listed in the Schedule of Assessments, including
serum creatinine >1.5× the upper limits of normal and
serum tryptase concentration >11.4 ng/mL
Chronic medical condition that in the judgment of the investigator(s) would interfere
with the performance of the study or would place the subject at undue risk
such as, but not limited to
Uncontrolled infection or infection requiring antibiotics
Uncontrolled cardiac failure: Classification III or IV New York Heart Association
History of cerebrovascular or cardiac disorders, or subjects at particular risk of sequelae following a short hypotensive episode, including subjects with systolic BP <100 mmHg and/or diastolic BP <60 mmHg at screening or Day 1
Uncontrolled systemic or gastrointestinal inflammatory conditions
Known bone marrow dysplasia
History of positive tests for human immunodeficiency virus/acquired immunodeficiency syndrome or active hepatitis B or C
History of systemic autoimmune disease requiring anti-inflammatory or immunosuppressive therapy within 3 months prior to Day 1, with the following
exceptions
i. Subjects with a history of autoimmune thyroiditis are eligible provided the subject requires only thyroid hormone replacement therapy and disease has been stable for ≥1 year
ii. Subjects with well-controlled type I diabetes (in the opinion of the investigator)
are eligible
h. Known mast cell activation syndrome, mastocytosis, or chronic idiopathic urticaria
Known sensitivity to any of the ingredients in the study medication
Elective surgery within 4 weeks prior to the screening visit, during the study, or 4
weeks after the treatment period
Evidence of current chronic alcohol or drug abuse
Current enrollment in an investigational drug or device study or participation in such
a study within 4 weeks of the screening visit
In the investigator's opinion, evidence of unwillingness, or inability to follow the
restrictions of the protocol and complete the study
Females who are pregnant or breastfeeding
BCC Lesion Exclusion Criteria
Recurrent or previously treated lesions
Lesions within 1 cm of the eyelids or lips, or on the hands, feet, ears, nose, and
genitalia
Histological evidence of any other tumor in the biopsy specimen
Histological evidence of infiltrative, desmoplastic, sclerosing, or morpheaform BCC
subtypes in the biopsy specimen
Medium- and high-risk basal cell carcinomas as defined by the National Comprehensive
Cancer Network (NCCN) or Mohs Appropriate Use Criteria (ie, BCCs eligible for Mohs
surgery)
TARGET LESION EXCLUSION ONLY
For subjects with severe stasis dermatitis, target BCC lesions may not be on the lower
extremities
Within 2 cm of the target BCC lesion(s)
Treatment with the following topical agents within the 12 weeks prior to the
screening visit: aminolevulinic acid, 5-fluorouracil, corticosteroids
diclofenac, imiquimod, ingenol mebutate
Treatment with surgical excision, or curettage within the 2 weeks prior to the
screening visit
Evidence of dermatological disease or confounding skin condition that may
interfere with clinical evaluation (ie, psoriasis, atopic dermatitis, eczema
propensity to form keloids or hypertrophic scarring)
Use of topical immunomodulators during study
Within 5 cm of the target BCC lesion(s): history of any skin cancer, except for other
currently identified target and nontarget BCC lesions
Target BCC lesion is in the area of prior resurfacing procedure with CO2 laser or any
photodynamic and phototherapy treatment within the 3 months prior to the screening
visit
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