Phase 1 Study of PLN-101095 for Advanced Solid Tumors
This study is testing a new drug called PLN-101095 in adults with advanced or metastatic (spread to other parts of the body) solid tumors. You might be able to join if your cancer has progressed after at least 12 weeks of treatment with anti-PD-1 or anti-PD-L1 therapies like pembrolizumab, and you initially showed some benefit from that treatment. The main goals are to see how safe PLN-101095 is when given with pembrolizumab, how well people tolerate it, and if it shows any signs of shrinking tumors. The study is currently unclear about its recruitment status and plans to enroll about 124 participants.
- Study design
- This is a Phase 1a/1b, open-label study, meaning you and your doctors will know which treatment you are receiving. It involves increasing doses of PLN-101095 in combination with pembrolizumab.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety and tolerability will be monitored from the first dose until 16 weeks after your last study treatment. Anti-tumor activity will be tracked until your disease progresses or death.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Phase 1 Study of PLN-101095 in Adults With Advanced or Metastatic Solid Tumors
At a glance
Conditions
Where it's being run
12 sites across 9 statesStudy leadership
- Pliant Therapeutics Medical Monitor · STUDY_DIRECTOR · Pliant Therapeutics, Inc.
Who to contact
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What this trial measures
- Safety and tolerability of PLN-101095 in combination with pembrolizumab in Parts 1 and 2First 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 2Day 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 2First 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 2First 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.