A Phase 2 Study of Intratumoral Administration of L19IL2/L19TNF in Locally Advanced Basal Cell Carcinoma Patients Progressing or Intolerant to Systemic Treatment.
Philogen S.p.A.
Summary
Open-label, single-arm, multicentre study in patients with locally advanced BCC amenable to intratumoral injection, who have progressed on or are intolerant to systemic therapy as determined by a local multidisciplinary tumor board. The primary objective of the study is to evaluate the activity of intratumoral L19IL2/L19TNF, while the secondary objective is to assess the safety and efficacy. The patients will receive multiple intratumoral administrations of combined L19IL2 and L19TNF to all injectable cutaneous and subcutaneous lesions once weekly for up to 4 weeks: for those who have a partial response or stable disease as their best response, a second 4-week course L19IL2/L19TNF of four weekly injections may be administered as per treating physician judgement. Patients will be followed for a maximum of 160 weeks after beginning of treatment.
Description
Tumor Assessment (TA) visits will be performed at Week 8 (Day 50 from the beginning of treatment), Week 12 (Day 78), and then every 8 weeks for the first year of Follow-up (FU). During second and third years of FU, TA visits will be performed every 12 Weeks. In case a response (CR, PR) or stable disease is observed, a confirmatory assessment of the tumor response will be performed 4 weeks after the TA visit, when the response was first recorded. Confirmation of response will be assessed by histopathological analysis of specimens from the skin treated area by multiple punch biopsies. Confirmat…
Eligibility
- Age range
- 18–100 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients must have histologically documented, locally advanced BCC. * Patients must have at least one injectable and measurable cutaneous or subcutaneous lesion. * Patients must have locally advanced BCC that has progressed on or cannot tolerate ICI treatment as assessed by a local multidisciplinary tumor board. * Patients with nodal, regional or in transit injectable BCC lesions. * Patients must be willing to provide tissue from a core or excisional biopsy of a tumor lesion at screening and for confirmation of Objective Response or Stable Disease. * Male or female patie…
Interventions
- DrugL19IL2/L19TNF
intratumoral administrations
Locations (3)
- H. Lee Moffitt Cancer Center and Research Institute Hospital, Inc.Tampa, Florida
- Winship Cancer Institute, Emory UniversityAtlanta, Georgia
- The University of Texas MD Anderson Cancer CenterHouston, Texas