Tumor-localized CD40 agonism with MP0317, a FAP x CD40 DARPin, reprograms the tumor microenvironment in patients with advanced solid tumors: an open-label, nonrandomized, dose-escalation phase 1 study - Summary - MDSpire

Tumor-localized CD40 agonism with MP0317, a FAP x CD40 DARPin, reprograms the tumor microenvironment in patients with advanced solid tumors: an open-label, nonrandomized, dose-escalation phase 1 study

  • By

  • Neeltje Steeghs

  • Carlos Gomez-Roca

  • Iphigénie Korakis

  • Eelke Gort

  • Hilde De Winter

  • Nina Stojcheva

  • Vaia Stavropoulou

  • Jennifer Krieg

  • Paul Baverel

  • Elena Fernandez

  • Ana Maria Florescu

  • Lea Hoenig

  • Michael Peter Sanderson

  • Vladimir Kirkin

  • Philippe Legenne

  • Philippe Alexandre Cassier

  • May 1, 2026

  • 0 min

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Objective:

To evaluate the safety and efficacy of MP0317, a bispecific DARPin targeting CD40 and FAP, in patients with advanced solid tumors, focusing on primary endpoints such as overall response rate and safety profile.

Key Findings:
  • 46 patients were treated, with a median age of 63 years and a median of four prior treatment lines.
  • The most common tumor types included colorectal cancer, pancreatic cancer, mesothelioma, and NSCLC.
  • 415 treatment-emergent adverse events were reported, with 118 classified as treatment-related; the significance of these events should be noted.
  • No treatment-related adverse events greater than grade 3 were observed.
Interpretation:

MP0317 demonstrated a favorable safety profile with manageable adverse events, suggesting potential for further development in cancer therapy, particularly in larger trials.

Limitations:
  • Small sample size limits generalizability.
  • Short treatment duration may not fully capture long-term effects, and potential biases in a nonrandomized study should be considered.
Conclusion:

MP0317 shows promise as a targeted therapy for advanced solid tumors, warranting further investigation in larger studies, particularly focusing on long-term outcomes.

Original Source(s)

Tumor-localized CD40 agonism with MP0317, a FAP x CD40 DARPin, reprograms the tumor microenvironment in patients with advanced solid tumors: an open-label, nonrandomized, dose-escalation phase 1 study

  • by Neeltje Steeghs, Carlos Gomez-Roca, Iphigénie Korakis, Eelke Gort, Hilde De Winter, Nina Stojcheva, Vaia Stavropoulou, Jennifer Krieg, Paul Baverel, Elena Fernandez, Ana Maria Florescu, Lea Hoenig, Michael Peter Sanderson, Vladimir Kirkin, Philippe Legenne, Philippe Alexandre Cassier

  • May 1, 2026

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