A phase Ib/II study of modakafusp alfa alone and in combination with pembrolizumab in patients with advanced or metastatic solid tumors.

ABSTRACT:

Background

Modakafusp alfa is a novel immunocytokine comprising two attenuated interferon-α2b molecules fused to an anti-CD38 IgG4 monoclonal antibody. Modakafusp alfa has shown immune cell activation and antitumor activity in preclinical mouse models, including in combination with an anti-programmed cell death (PD-1) receptor in tumors that do not express CD38, and demonstrated clinical responses and immune activation in patients with relapsed/refractory multiple myeloma.

Methods

In phase Ib, adult patients with advanced/metastatic solid tumors received escalating doses of modakafusp alfa 0.1-1.5 mg/kg intravenously every 3 weeks (Q3W) across six dosing cohorts. In phase II, patients with unresectable/metastatic cutaneous melanoma and resistance to ≤2 anti-PD-1 therapies in

SUBMITTER: Gill D 

PROVIDER: S-EPMC12722991 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature