A Phase 1 Study of PLN-101095 in Adults With Advanced or Metastatic Solid Tumors
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
Timeline
- Start
- 2023-08-30
- Primary completion
- 2030-06
- Completion
- 2030-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PLN-101095 | Unknown | 250 mg | — |
| Subject | PLN-101095 | Unknown | 500 mg | — |
| Subject | PLN-101095 | Unknown | 1000 mg | — |
| Subject | PLN-101095 | Unknown | 2000 mg | — |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |
Indications
No indication recorded.