Pliant Therapeutics Announces Interim Data from PLN-101095 Clinical Trial

Pliant Therapeutics announced interim data from its Phase 1 dose escalation clinical trial evaluating PLN-101095, in combination with pembrolizumab, in patients with immune checkpoint inhibitor-refractory advanced or metastatic solid tumors. PLN-101095 is an oral, small molecule, dual selective inhibitor of alphavbeta8 and alphavbeta1. It is the fourth clinical-stage drug candidate to be generated from Pliant's integrin-based drug development platform. In a heavily pretreated patient population with advanced and/or metastatic solid tumors refractory to ICIs, PLN-101095 demonstrated anti-tumor activity in combination with pembrolizumab. Across the three highest dose cohorts, there were four responders consisting of one confirmed complete response and three partial responses out of the 10 secondary ICI refractory patients. Clinical responses were observed in patients with cholangiocarcinoma, melanoma, head and neck squamous cell carcinoma and non-small cell lung cancer. The median time on treatment in these patients is 15 months, as of November 30th, 2025. Sixty percent of secondary refractory patients demonstrated stable disease or tumor reduction. Pliant plans to accelerate the development of PLN-101095 with the initiation of a Phase 1b indication expansion trial assessing NSCLC and other tumor types with strong mechanistic rationale for integrin inhibition in 2026.