NextCure has started a Phase I/II clinical trial of NC318 for the treatment of patients with advanced or metastatic solid tumours.
In the Phase I dose-escalation portion of the trial, NextCure will investigate the safety and tolerability of NC318 in patients with advanced or metastatic solid tumours, and establish the maximum tolerated dose of NC318.
The trial's Phase II will begin once the maximum tolerated dose is achieved and will evaluate the efficacy of NC318 in selected tumour types.
Its primary endpoint is the number of subjects with treatment-emergent adverse events, as assessed by common terminology criteria for adverse events v5.0 (CTCAE v5.0), and determining a maximum tolerated dose (MTD) or pharmacologically active dose (PAD).
The trial’s secondary endpoints include disease response, maximum llasma concentration (Cmax) of NC318, and others.
NextCure CMO Kevin Heller said: “Immunotherapies targeting T cell function have significantly improved patient outcomes, however a substantial proportion of patients do not respond to currently approved PD-1 or PD-L1 antibody therapies.
“Laboratory studies demonstrate that Siglec-15 modulates immune suppression in a manner independent of the PD-1/PD-L1 pathway, suggesting that NC318 may have the potential to be used in patients who do not express PD-L1.
“Blocking S15 with NC318 is expected to diminish immunosuppression and normalise the immune response, resulting in a clinically relevant anti-tumour immune response. A goal of our trial is to test that hypothesis.”
NC318 is an S15 antibody and has demonstrated an ability to block the negative effects of S15 in preclinical studies.
The immunomedicine has the potential to treat various cancer types.