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Clinical Trials in Spain / NCT06270706
Recruiting Phase 1

A Phase 1 Study of PLN-101095 in Adults With Advanced or Metastatic Solid Tumors

NCT06270706 · tracked via the Priya Life Science Spain tracker
Sponsor
Pliant Therapeutics, Inc
Phase
Phase 1
Started
2023-08-30
Last updated
2026-10-02

Condition(s) studied

Advanced or Metastatic Solid Tumor

Investigational drug(s) / intervention(s)

PLN-101095PLN-101095PLN-101095PLN-101095PLN-101095PLN-101095Pembrolizumab →

PLN-101095: PLN-101095 250 mg BID

PLN-101095: PLN-101095 500 mg BID

PLN-101095: PLN-101095 1000 mg BID

PLN-101095: PLN-101095 1000 mg TID

PLN-101095: PLN-101095 2000 mg BID

PLN-101095: PLN-101095

Pembrolizumab: Pembrolizumab (KEYTRUDA) 200 mg IV Q3W

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Has histologically or cytologically confirmed advanced or metastatic solid tumor 2. Have received ≥12 weeks of continuous anti-PD-1 or anti-PD-L1 treatment administered as monotherapy or in combination with other anticancer therapies 3. Have demonstrated documented prior clinical benefit, defined as CR or PR at any time during treatment, or SD lasting ≥6 months (Part 2 only) 4. 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 5. At least 1 measurable lesion, as defined by RECIST v1.1 6. Estimated survival of ≥3 months 7. Have adequate bone marrow and organ function. 8. A female participant is eligible to participate if she is not pregnant, not breastfeeding Exclusion Criteria: 1. Any immune-related medical conditions that would put participants at greater risk when receiving pembrolizumab 2. Has a known additional malignancy that is progressing or has required active treatment within the past 2 years 3. Has received prior radiotherapy within 2 weeks for palliative bone-directed therapy and 4 weeks for all other radiotherapy 4. 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 5. Has a diagnosis of immunodeficiency or use of systemic steroids \>10 mg/day 6. Has an active autoimmune disease that has required systemic treatment in the past 2 years 7. Has known active CNS metastases (brain and/or leptomeningeal metastases) 8. Has significant cardiac disease 9. Has an active infection requiring systemic therapy (including uncontrolled HIV, Hepatitis B and C) 10. 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

Primary outcome measure(s)

  • Safety and tolerability of PLN-101095 in combination with pembrolizumab in Parts 1 and 2 — First dose to 35 days
    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.
  • Safety and tolerability of PLN-101095 in combination with pembrolizumab in Parts 1 and 2 — Day 1 until 16 weeks after end of study treatment regimen
    Proportion of participants with treatment-emergent adverse events and serious adverse events.
  • Anti-tumor activity of PLN-101095 in combination with pembrolizumab in Part 2 — First dose to disease progression or death from any cause, whichever occurs first.
    Proportion of participants achieving confirmed iPR or iCR per iRECIST Version 1.1.
  • Anti-tumor activity of PLN-101095 in combination with pembrolizumab in Part 2 — First dose to disease progression or death from any cause, whichever occurs first.
    Proportion of participants who maintain disease control (iCR, iPR or iSD) per iRECIST Version 1.1.

Trial sites (22)

FacilityCityRegionStatus
Yale University New Haven Connecticut Completed
Winship Cancer Institute of Emory University Atlanta Georgia Recruiting
South Texas Accelerated Research Therapeutics (START) Grand Rapids Michigan Recruiting
Washington University Medicine St Louis Missouri Recruiting
START New Jersey East Brunswick New Jersey Recruiting
START New York Long Island LLC Lake Success New York Recruiting
Carolina Cancer Research Center Wilson North Carolina Recruiting
Avera Medical Group Sioux Falls South Dakota Recruiting
Tennessee Oncology Nashville Tennessee Recruiting
NEXT Austin Austin Texas Recruiting
START Center for Clinical Research Fort Worth Texas Recruiting
University of Texas MD Anderson Cancer Center Houston Texas Recruiting
NEXT Houston Houston Texas Recruiting
START Mountain Region West Valley City Utah Recruiting
Inova Schar Cancer Institute Fairfax Virginia Recruiting
NEXT Virginia Fairfax Virginia Recruiting
Hospital Universitari Quirónsalud (NEXT Barcelona) Barcelona Barcelona Recruiting
START Barcelona - Hospital HM Nou Delfos Barcelona Barcelona Recruiting
START Center for Cancer Research - La Rioja Logroño La Rioja Recruiting
START Madrid - Hospital Universitario Fundación Jiménez Díaz Madrid Madrid Recruiting
START Madrid - Centro Integral Oncológico Clara Campal Madrid Madrid Recruiting
University Hospital Quironsalud Madrid (NEXT Madrid) Madrid Pozuelo de Alarcón Recruiting

On this site

📄 Keytruda (pembrolizumab) drug profile →

Other trials for the same condition

Study of Sacituzumab Govitecan in Participants With Advanced or Metastatic Solid Tumor and Moderate Liver Impairment Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06270706 on ClinicalTrials.gov ↗ ← All trials in Spain