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                                    <figcaption>Following monotherapy, the drug was dosed at 200mg intravenously every three weeks. Credit: PeopleImages / Shutterstock.com.</figcaption>
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<p>Pliant Therapeutics has reported interim results from its ongoing Phase I dose escalation trial of PLN-101095, along with pembrolizumab in patients with solid tumours.</p>



<p>The drug evaluation is intended to treat patients with immune checkpoint inhibitor (ICI)-refractory advanced or metastatic tumours.</p>



<p>PLN-101095 is a dual selective, oral, small molecule alpha-v beta-8 (αvβ8) and αvβ1 inhibitor, and is the fourth clinical-stage drug developed from the company’s integrin-based platform.</p><div>
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<p>In this study, the drug candidate combined with pembrolizumab showed anti-tumour activity in patients whose advanced or metastatic solid tumours were refractory to ICIs.</p>



<p>Four responses were observed out of ten secondary ICI-refractory participants, among the three highest dose groups, including three partial responses (two confirmed, one unconfirmed) and one confirmed complete response.</p>



<p>Clinical outcomes were noted in patients with head and neck squamous cell carcinoma, cholangiocarcinoma, non-small cell lung cancer, and melanoma.</p>



<p>As of 30 November 2025, the median time on treatment was 15 months, and 60% of secondary refractory patients achieved tumour reduction or stable disease.</p>



<p>All those who responded showed significant increases in plasma interferon gamma (IFN-γ), ranging from four-fold to 13-fold versus baseline, after a 14-day monotherapy run-in with PLN-101095.</p>



<p>The drug was generally observed to be well tolerated throughout all tested doses, with only two discontinuations because of adverse events, and showed a dose-dependent pharmacokinetic profile.</p>



<p>In the trial, 16 patients with nine different tumour types were enrolled in five groups.</p>



<p>Dosing regimens for PLN-101095 monotherapy included 250mg twice a day (BID) for one participant, 500mg BID for two, 1,000mg BID for six subjects, 1,000mg three times daily for four participants, and 2,000mg BID for three patients.</p>



<p>Following monotherapy, pembrolizumab was dosed at 200mg intravenously every three weeks.</p>



<p>Pliant plans to commence a Phase Ib indication expansion trial next year to assess PLN-101095 in non-small cell lung cancer (NSCLC) and other tumour types.</p>



<p>Pliant Therapeutics CEO Bernard Coulie said: “These data surpassed our expectations given the number of clinical responses observed with PLN-101095 in difficult-to-treat ICI refractory tumours in similar Phase I trials.</p>



<p>“The growing validation of PLN-101095’s mechanism of action, including the supportive IFN-γ biomarker correlation, gives us confidence in PLN-101095’s development. We believe PLN-101095 has the potential to create new treatment options for patients in need and deliver significant value for investors.”</p>



<p>In March 2023, Pliant started participant enrolment in the Phase IIa INTEGRIS-PSC trial of bexotegrast (PLN-74809) at 320mg doses in patients with primary sclerosing cholangitis (PSC).</p>
                        
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<p>Pliant Therapeutics reported interim results from its Phase I trial of PLN-101095 with pembrolizumab in solid tumour patients. The trial showed anti-tumour activity, with four responses among ten ICI-refractory participants. The drug was well tolerated, with a dose-dependent pharmacokinetic profile. Pliant plans a Phase Ib trial next year for further assessment. CEO Bernard Coulie expressed optimism about PLN-101095's potential to offer new treatment options and value for investors.</p>

Pliant Therapeutics reports interim PLN-101095 Phase I trial data