Safety and activity of RO7300490, a bispecific CD40 agonist targeted to fibroblast activation protein, in patients with advanced solid tumors: a single-arm, multicenter, first-in-human, phase 1 trial.

Q: What does this research mean for the field?

Treatment with RO7300490, a tumor-targeted CD40 agonist antibody, is feasible, clinically manageable, and induces immunomodulation of the tumor microenvironment in patients with advanced solid tumors. Novelty: ClaimNovelty.NOVEL_FINDING. Consensus alignment: ConsensusAlignment.NEUTRAL.

Ignacio Melero; Bernhard Reis; Corinne Rusterholz; Alexandra Epp; Nicole A. Kratochwil; Wu Chun; Michael Hettich; Georgios Kazantzidis; Natascha Rieder; Petra C Schwalie; Solveig Badillo; Nadine Kumpesa; Andreas Thommen; Daniëlle J. Vugts; Victor Moreno; Julia Lostes Bardaji; Eduardo Castañón Álvarez; Carlos E de Andrea; Iben Spanggaard; D H Lee; James Spicer; Fiona Thistlethwaite; Do-Youn Oh; Antoine Hollebecque; Olivera Cirovic; Stefan N Symeonides

doi:10.1038/s43018-026-01157-8

Key Points

This research aims to evaluate the safety and activity of RO7300490, a bispecific CD40 agonist, in patients with advanced solid tumors.
Conducted as a single-arm, multicenter, first-in-human, phase 1 trial
Involved collecting paired tumor biopsies to assess immune cell density
Registered under ClinicalTrials.gov with ID NCT04857138.
Treatment induced an increase in B cell density within tumors
Formation of pretertiary lymphoid structures was observed
Immunomodulation of the tumor microenvironment was clinically manageable and feasible.

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Implication

Demonstrates immunomodulation of the tumor microenvironment in advanced solid tumors, suggesting therapeutic potential.

Abstract

DC density in paired tumor biopsies. An increase in B cell density was also observed, along with the formation of pretertiary lymphoid structures, co-organized in focal micro-neighborhoods with DCs. In summary, treatment with a tumor-targeted CD40 agonist antibody is feasible, clinically manageable and induces immunomodulation of the tumor microenvironment. ClinicalTrials.gov registration: NCT04857138 .

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Cite This Study

Melero et al. (2026) studied this question.

synapsesocial.com/papers/69f837003ed186a739981138 https://doi.org/10.1038/s43018-026-01157-8

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Safety and activity of RO7300490, a bispecific CD40 agonist targeted to fibroblast activation protein, in patients with advanced solid tumors: a single-arm, multicenter, first-in-human, phase 1 trial.

Key Points

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Implication

Abstract

Discussion

Cite This Study

Safety and activity of RO7300490, a bispecific CD40 agonist targeted to fibroblast activation protein, in patients with advanced solid tumors: a single-arm, multicenter, first-in-human, phase 1 trial.

Key Points

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Implication

Abstract

Discussion

Cite This Study

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