A Phase 1 Study of PLN-101095 in Adults With Advanced or Metastatic Solid Tumors
Solid Tumor
Unknown Primary
18 Years and older, Male and Female
PLN-101095-ONC-101 (primary)
NCI-2024-01965
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
- Part 2: Dose-expansion cohorts using Simon's 2-stage design
Eligibility
- Has histologically or cytologically confirmed advanced solid tumor
- Has an advanced or metastatic solid tumor (for which pembrolizumab is indicated) and have evidence of disease progression after treatment with pembrolizumab.
- At least 1 measurable lesion, as defined by RECIST v1.1
- Estimated survival of =3 months
- No effective therapeutic options available (eg, has received standard of care or is intolerant of, refuses, or is not eligible for standard of care antineoplastic therapy)
Treatment Sites in Georgia
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