protocolSection identificationModule nctId: NCT06270706, orgStudyIdInfo id: PLN-101095-ONC-101, briefTitle: A Phase 1 Study of PLN-101095 in Adults With Advanced or Metastatic Solid Tumors, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-30, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Pliant Therapeutics, Inc., class: INDUSTRY, descriptionModule briefSummary: 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* Part 2: Dose-expansion cohorts using Simon's 2-stage design, conditionsModule conditions: Metastatic Solid Tumor, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 77, type: ESTIMATED, armsInterventionsModule interventions name: PLN-101095, interventions name: Pembrolizumab, outcomesModule primaryOutcomes measure: Proportion of participants with treatment-emergent adverse events and serious adverse events per CTCAE Version 5.0., primaryOutcomes measure: Number of participants with a Dose Limiting Toxicity (DLT) defined as toxicities that meet predefined severity criteria, assess as having a suspected relationship to study drug, unrelated to disease, inter-current illness, or concomitant medications., secondaryOutcomes measure: Maximum observed plasma concentration (Cmax) to characterize the plasma pharmacokinetics (PK)., secondaryOutcomes measure: Time to maximum observed concentration (Tmax) to characterize the plasma pharmacokinetics (PK)., secondaryOutcomes measure: Area under the concentration-time curve over a dosing interval (AUC0-τ) to characterize the plasma pharmacokinetics (PK)., secondaryOutcomes measure: Disease control rate (DCR) is defined by the proportion of participants who maintain disease control (iCR, iPR or iSD) per iRECIST Version 1.1., secondaryOutcomes measure: Objective response rate (ORR) is defined by the proportion of participants with an iCR or iPR per iRECIST Version 1.1., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: South Texas Accelerated Research Therapeutics (START), status: RECRUITING, city: Grand Rapids, state: Michigan, zip: 49546, country: United States, geoPoint lat: 42.96336, lon: -85.66809, locations facility: NEXT Austin, status: RECRUITING, city: Austin, state: Texas, zip: 78758, country: United States, geoPoint lat: 30.26715, lon: -97.74306, locations facility: University of Texas MD Anderson Cancer Center, status: RECRUITING, city: Houston, state: Texas, zip: 77030, country: United States, geoPoint lat: 29.76328, lon: -95.36327, locations facility: NEXT Virginia, status: RECRUITING, city: Fairfax, state: Virginia, zip: 22031, country: United States, geoPoint lat: 38.84622, lon: -77.30637, hasResults: False