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)

This study is testing a new experimental drug, PLN-101095, for patients with advanced cancers that have stopped responding to standard immunotherapy. The goal is to see if adding this new drug to a well-known immunotherapy (pembrolizumab) can help restart the body's ability to fight the cancer.

This study is for adults whose cancer has spread and continued to grow even after receiving standard immunotherapy treatment. You may be eligible if your cancer previously responded to treatment but has recently started growing again.

Participants will receive the study treatment while doctors closely monitor their safety and how their bodies react to the medication. The study happens in stages, starting with smaller doses to ensure safety before expanding to larger groups to see how well the treatment works.

The study is currently recruiting patients at specific medical centers in New Haven, Connecticut; Atlanta, Georgia; and Grand Rapids, Michigan. If you are interested, your doctor can help determine if a site near you is a good fit.