A Phase 1a/1b Multicenter, Open-label Dose Escalation/Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of PLN-101095 as Monotherapy and in Combination With Pembrolizumab in Adult Participants With Advanced or Metastatic Solid Tumors Who Have Disease Progression While on Pembrolizumab
- Study HIC#:2000035625
- Last Updated:03/28/2025
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
Contact Us
For more information about this study, including how to volunteer, contact:
Ingrid Palma
- Phone Number: 1-203-785-6431
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You can help our team find trials you might be eligible for by creating a volunteer profile in MyChart. To get started, create a volunteer profile, or contact helpusdiscover@yale.edu, or call +18779788343 for more information.
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- Any immune-related medical conditions that would put participants at greater risk when receiving pembrolizumab
- Previous treatment with pembrolizumab <21 days prior to the first dose of combination therapy of pembrolizumab and PLN-101095
- Received an immunotherapy other than pembrolizumab in the last 4 weeks prior to the first dose of PLN-101095
- Received radiotherapy (RT) within 1 week for palliative bone-directed therapy and 4 weeks for all other types, prior to the first dose of PLN-101095
- Received chemotherapy or other targeted therapies within 2 weeks prior to the first dose of PLN-101095
- Received a cell therapy within the last 12 months prior to the first dose of PLN-101095
- Known active central nervous system (CNS) metastases (brain and/or leptomeningeal metastases)
- Pregnant or lactating female participant