M0324 / EMD Serono - LARVOL DELTA

TITER: M0324 as Monotherapy and in Combination With Pembrolizumab or Chemotherapy in Participants With Selected Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=77 | Recruiting | Sponsor: EMD Serono Research & Development Institute, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • IO biomarker • Monotherapy • Solid Tumor

TITER: M0324 as Monotherapy and in Combination With Pembrolizumab or Chemotherapy in Participants With Selected Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=77 | Not yet recruiting | Sponsor: EMD Serono Research & Development Institute, Inc.

IO biomarker • Monotherapy • New P1 trial • Solid Tumor

M0324, a novel MUC-1 conditional CD40 agonist for selective immune activation in MUC-1 overexpressing tumors (AACR 2025) - "M0324 is the first MUC-1 conditional CD40 agonist, engineered to selectively activate immune cells in the presence of MUC-1 overexpressing tumor cells. The conditional mode of action of M0324 leverages the high expression of MUC-1 in carcinomas to induce targeted antitumor immunity, potentially overcoming the safety limitations of traditional CD40 agonists. Our encouraging preclinical data support the clinical investigation of M0324 in patients with MUC-1 overexpressing tumors."

IO biomarker • Oncology • CD40 • MUC1