TerminatedPhase 1

Study of OBT076 Associated or Not in Patients With Recurrent or Metastatic Adenoid Cystic Carcinoma of the Head and Neck

Stopped: toxicity

France19 participantsStarted 2023-11-29

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Male or Female ≥ 18 years
✓. ECOG PS 0-1
✓. Histologically confirmed Adenoid Cystic Carcinoma (AdCC) of the Head and Neck or trachea
✓. Histologically and/or radiologicaly documented recurrent or metastatic AdCC not amenable to surgery and/or radiotherapy
✓. Patients with confirmed disease progression at study entry. The screening radiological evaluation (CT/MRI of H\&N, chest, pelvis and brain if known or suspected cerebral involvement) should demonstrate disease progression according to RECIST 1.1 when compared to a prior disease assessment done within 6 months period prior to screening
✓. Measurable disease by CT scan or MRI according to RECIST 1.1 criteria
✓. Adequate haematologic, renal and hepatic function as indicated by (using CTCAE v5.0):
✓. The Investigator confirms that the participant agrees to use appropriate contraception and barriers methods, if applicable. The contraception, barrier, and pregnancy testing requirements are below:

Exclusion criteria

What they're measuring

Objective Response Rate (ORR)

Timeframe: through study completion, an average of 1 year"

Trial details

NCT IDNCT05930951

SponsorGroupe Oncologie Radiotherapie Tete et Cou

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-10-09

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