Study of OBT076 Associated or Not in Patients With Recurrent or Metastatic Adenoid Cystic Carcinoma of the Head and Neck
Status:
Recruiting
Trial end date:
2027-09-01
Target enrollment:
Participant gender:
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 CD205/Ly75-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 CD205/Ly75, 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 patient's immune response against the tumor, especially PD-1 targeted
therapies4.
Based on this rational and on the high level of expression of CD205/Ly75 in AdCC, the
hypothesis tested in this study is that OBT076 could be a potential effective treatment for
R/M 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.