Tests PLN-101095 with pembrolizumab in adults with advanced solid tumors

Trial details

Who runs it

Pliant Therapeutics, Inc.

Trial code

NCT06270706

Record updated

2 October 2026

Original description

This is a Phase 1a/1b, dose-escalation/expansion, consecutive-cohort, open-label study to evaluate the safety, tolerability, PK, PD, and preliminary evidence of antitumor activity of PLN-101095 in combination with pembrolizumab (the study treatment regimen) in adult participants with advanced or metastatic solid tumors for which pembrolizumab is indicated but have documented disease progression (refractory [primary resistance]) or relapsed [secondary resistance]) after at least 3 months from the start of treatment with pembrolizumab.Read full original descriptionShow less

A Phase 1a/1b Multicenter, Open-label Dose Escalation/Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of PLN-101095 as Monotherapy and in Combination With Pembrolizumab in Adult Participants With Advanced or Metastatic Solid Tumors Who Have Disease Progression While on an Immune Checkpoint Inhibitor (FORTIFY)

This is a Phase 1a/1b, dose-escalation/expansion, consecutive-cohort, open-label study to evaluate the safety, tolerability, PK, PD, and preliminary evidence of antitumor activity of PLN-101095 in combination with pembrolizumab (the study treatment regimen) in adult participants with advanced or metastatic solid tumors for which pembrolizumab is indicated but have documented disease progression (refractory [primary resistance]) or relapsed [secondary resistance]) after at least 3 months from the start of treatment with pembrolizumab.

The study will consist of 2 main parts:

* Part 1: Consecutive dose-escalation cohorts using a Bayesian optimal interval (BOIN) dose escalation design with accelerated titration * Part 2: Dose-expansion cohorts using Simon's 2-stage design

Inclusion: Has histologically or cytologically confirmed advanced or metastatic solid tumor; Have received ≥12 weeks of continuous anti-PD-1 or anti-PD-L1 treatment administered as monotherapy or in combination with other anticancer therapies; Have demonstrated documented prior clinical benefit, defined as CR or PR at any time during treatment, or SD lasting ≥6 months (Part 2 only); Must have subsequently developed radiographic disease progression while receiving anti-PD-1 or anti-PD-L1 treatment or within ≤12 weeks after the last dose of such treatment; At least 1 measurable lesion, as defined by RECIST v1.1; Estimated survival of ≥3 months; Have adequate bone marrow and organ function; A female participant is eligible to participate if she is not pregnant, not breastfeeding.

Exclusion: Any immune-related medical conditions that would put participants at greater risk when receiving pembrolizumab; Has received prior radiotherapy within 2 weeks for palliative bone-directed therapy and 4 weeks for all other radiotherapy; Has undergone major surgery within 4 weeks prior to the first dose of study treatment or has not adequately recovered from surgery or related complications; Has a diagnosis of immunodeficiency or use of systemic steroids >10 mg/day; Has received a live or live-attenuated vaccine within 30 days or a non-live vaccine within 7 days prior to the first dose of PLN-101095; Has a known additional malignancy that is progressing or has required active treatment within the past 2 years; Has an active autoimmune disease that has required systemic treatment in the past 2 years; Has significant cardiac disease; Has an active infection requiring systemic therapy (including uncontrolled HIV, Hepatitis B and C); Has known active CNS metastases (brain and/or leptomeningeal metastases).

ClinicalTrials.gov NCT06270706