A Phase 1 Study of PLN-101095 in Adults With Advanced or Metastatic Solid Tumors
ConditionAdvanced or Metastatic Solid Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorPliant Therapeutics, Inc.
About this trial
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 criteria
Qualifiers
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
Disqualifiers
Any immune-related medical conditions that would put participants at greater risk when receiving pembrolizumab
Has a known additional malignancy that is progressing or has required active treatment within the past 2 years
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
Trial design
Treatments tested in this trial
- PLN-101095
- PLN-101095
- PLN-101095
- PLN-101095
- PLN-101095
- PLN-101095
- Pembrolizumab
Treatment groups
124 Participants
are divided into 8 treatment groups8
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov