M0324 / EMD Serono - LARVOL DELTA

TITER, a Phase 1 study of M0324, a novel MUC-1-conditional CD40 agonist, in patients with selected advanced solid tumors (ESMO 2026) - No abstract available

Clinical • Metastases • P1 data • Oncology • Solid Tumor • CD40 • MUC1

Preclinical validation of the antitumor activity and safety of M0324, a novel MUC-1 conditional CD40 agonist, and its combination with immune checkpoint inhibitors (ICIs), for selective immune activation (AACR 2026) - P1 | "M0324 was shown to selectively activate DC and B cells only in the presence of MUC-1 expressing tumor cells, demonstrating superior in vitro and in vivo activity compared to anti-CD40 agonistic antibodies. M0324m further improved tumor control when combined with anti-PD-L1. M0324m was also well-tolerated in vivo."

Checkpoint inhibition • IO biomarker • Preclinical • Oncology • CD40 • MUC1

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

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