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May 30, 2026Journal of Clinical Oncology

Cohort expansion of a phase I study of PLN-101095, a first-in-class dual α v β 8 /α v β 1 integrin inhibitor, in combination with pembrolizumab in patients with advanced solid tumors refractory to immune checkpoint inhibitors (ICI).

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Authors

TYTimothy A. YapJGJames L. GulleyMSManish R. Sharma

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Overview

Randomized trial investigates immune response to PLN-101095 in advanced solid tumors, indicating potential for improved treatments.

Key Points

  • The study aims to evaluate the efficacy and safety of PLN-101095 in patients with advanced solid tumors resistant to immune checkpoint inhibitors.
  • Phase 1 open-label multicenter design
  • Part 1 involved dose escalation with Bayesian optimal interval design
  • Part 2 focuses on cohort expansion for specific tumor types based on secondary resistance to ICI.
  • Four responders observed, primarily in patients with high tumor mutational burden (TMB-H)
  • Primary endpoints include objective response rate (ORR) and disease control rate (DCR) assessed by immune RECIST
  • Exploratory analyses will assess integrin expression, TGF-β levels, and tumor microenvironment.

Cite This Study

Yap et al. (2026) studied this question.

synapsesocial.com/papers/6a1a7f990307b78509431dc3https://doi.org/10.1200/jco.2026.44.16_suppl.tps2690
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