Ignite Creation Date:
2024-05-06 @ 2:35 PM
Last Modification Date:
2024-10-26 @ 1:33 PM
Study NCT ID:
NCT04362722
Status:
RECRUITING
Last Update Posted:
2023-10-10
First Post:
2020-04-17
Brief Title:
Intratumoral Administration of Daromun in Non-melanoma Skin Cancer Patients
Sponsor:
Philogen SpA
Organization:
Philogen SpA
Study Overview
Official Title:
A Phase II Study of Intratumoral Administration of L19IL2L19TNF in Non-melanoma Skin Cancer Patients With Presence of Injectable Lesions
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DUNCAN
Brief Summary:
This clinical phase II study is designed to investigate the efficacy of intratumorally administered L19IL2L19TNF in patients with injectable lesions of BCC or cSCC Favorable tumor responses following intralesional treatment with L19IL2L19TNF have been observed in patients with injectable melanoma lesions of stage III or IV for injected and non-injected lesions
The proposed clinical phase II study plans to investigate the intralesional administration of 65 Mio IU of L19IL2 108 mg and 200 µg of L19TNF to be administered in an approximate volume of 10 mL as a single or multiple intratumoral injections in patients with high-risk BCC or cSCC
There is a high medical need for non-invasive therapeutic strategies with a comparable good response rate and high recurrence free survival for treatment of patients with BCC or cSCC who cannot be treated by or refuse surgery Surgery is not always applicable as it may not be feasible due to the anatomic location may have a poor cosmetic outcome for the patient or is generally not accepted as treatment strategy by the patient However current non-surgical treatment strategies have a considerably reduced response rate and recurrence free survival Based on the favorable results for injected and non-injected lesions obtained in the phase II study of L19IL2L19TNF and the good safety profile seen in the subsequent phase III study both in stage III or IV melanoma patients we believe that patients with BCC or cSCC will profit from intralesional treatment with L19IL2L19TNF
The proposed clinical phase II study plans to investigate the intralesional administration of 65 Mio IU of L19IL2 108 mg and 200 µg of L19TNF to be administered in an approximate volume of 10 mL as a single or multiple intratumoral injections in patients with high-risk BCC or cSCC
There is a high medical need for non-invasive therapeutic strategies with a comparable good response rate and high recurrence free survival for treatment of patients with BCC or cSCC who cannot be treated by or refuse surgery Surgery is not always applicable as it may not be feasible due to the anatomic location may have a poor cosmetic outcome for the patient or is generally not accepted as treatment strategy by the patient However current non-surgical treatment strategies have a considerably reduced response rate and recurrence free survival Based on the favorable results for injected and non-injected lesions obtained in the phase II study of L19IL2L19TNF and the good safety profile seen in the subsequent phase III study both in stage III or IV melanoma patients we believe that patients with BCC or cSCC will profit from intralesional treatment with L19IL2L19TNF
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None