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 an Immune Checkpoint Inhibitor (FORTIFY)

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

Eligibility

Age range

18+ years

Sex

All

Healthy volunteers

No

Interventions

• Drug
  PLN-101095

  PLN-101095 250 mg BID

• Drug
  PLN-101095

  PLN-101095 500 mg BID

• Drug
  PLN-101095

  PLN-101095 1000 mg BID

• Drug
  PLN-101095

  PLN-101095 1000 mg TID

• Drug
  PLN-101095

  PLN-101095 2000 mg BID

• Drug
  PLN-101095

  PLN-101095

• Drug
  Pembrolizumab

  Pembrolizumab (KEYTRUDA) 200 mg IV Q3W

Locations (6)