Ignite Creation Date:
2024-05-06 @ 7:13 PM
Last Modification Date:
2024-10-26 @ 3:02 PM
Study NCT ID:
NCT05930951
Status:
SUSPENDED
Last Update Posted:
2024-07-11
First Post:
2023-06-23
Brief Title:
Study of OBT076 Associated or Not in Patients With Recurrent or Metastatic Adenoid Cystic Carcinoma of the Head and Neck
Sponsor:
Groupe Oncologie Radiotherapie Tete et Cou
Organization:
Groupe Oncologie Radiotherapie Tete et Cou
Study Overview
Official Title:
A Phase Ib Study of OBT076 or OBT076 Followed by Balstilimab in Patients With Recurrent or Metastatic RM Adenoid Cystic Carcinoma AdCC of the Head and Neck HN
Status:
SUSPENDED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Toxicity
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AdCC_2023-01
Brief Summary:
Adenoid cystic carcinoma AdCC is a rare salivary gland malignant tumor that accounts for approximately 1-3 of all head and neck cancers AdCC is often charaterised by a long natural history with a propensity for indolent but relentless growth and dissemination Local recurrences and late distant metastases are common findings in about 35 of the patients and associated with a poor prognosis1 AdCC is among the most lethal salivary gland tumors2 with no proven therapy for metastatic disease Little is known about endogenous immune response directed against AdCC However in a relatively large series of 28 AdCC tumor the immune profiling has shown in most tumors high and frequent programmed death ligand 2 PD-L2 expression and PD-L1 was generally not expressed on tumor and infiltrating cells3
The Antibody Drug Conjugates ADCs are emerging as a novel therapeutic option in cancer treatment that looks promising for solid tumors An experimental CD205Ly75-directed ADC OBT076 induce potent cytotoxic and antitumor activity Recently the combination of immunohistochemistry IHC and tissue micro array TMA was performed in a series of 46 AdCC showing a unique profile with both frequent and high expression of CD205Ly75 much higher than for other solid tumors In a phase I study OBT076 demonstrated promising results for 3 patients with 2 partial responses and 1 complete response for a gastric cancer4 In this last patient analysis showed an increase in PD1 CD4 and CD8 cells suggesting that OBT076 activates the patients immune response against the tumor especially PD-1 targeted therapies4
Based on this rational and on the high level of expression of CD205Ly75 in AdCC the hypothesis tested in this study is that OBT076 could be a potential effective treatment for RM AdCC which is an orphan lethal disease The efficacy of OBT076 will be tested either alone or followed by an anti PD-1 inhibitor Balstilimab with the hypothesis that OBT076 will induce immune infiltrate that could restore sentivity to PD-1 targeting
The Antibody Drug Conjugates ADCs are emerging as a novel therapeutic option in cancer treatment that looks promising for solid tumors An experimental CD205Ly75-directed ADC OBT076 induce potent cytotoxic and antitumor activity Recently the combination of immunohistochemistry IHC and tissue micro array TMA was performed in a series of 46 AdCC showing a unique profile with both frequent and high expression of CD205Ly75 much higher than for other solid tumors In a phase I study OBT076 demonstrated promising results for 3 patients with 2 partial responses and 1 complete response for a gastric cancer4 In this last patient analysis showed an increase in PD1 CD4 and CD8 cells suggesting that OBT076 activates the patients immune response against the tumor especially PD-1 targeted therapies4
Based on this rational and on the high level of expression of CD205Ly75 in AdCC the hypothesis tested in this study is that OBT076 could be a potential effective treatment for RM AdCC which is an orphan lethal disease The efficacy of OBT076 will be tested either alone or followed by an anti PD-1 inhibitor Balstilimab with the hypothesis that OBT076 will induce immune infiltrate that could restore sentivity to PD-1 targeting
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