A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of NDI-219216 in Patients With Advanced Solid Tumors With/Without Microsatellite Instability and/or Deficient Mismatch Repair

What this Trial Is About

Researchers are evaluating the safety, tolerability, and effects of NDI-219216 in patients with advanced solid tumors, including those with or without microsatellite instability and deficient mismatch repair. This early phase 1/2 study aims to understand how NDI-219216 affects tumor size, its side effects, and its impact on the body. The trial is sponsored by Nimbus Wadjet, Inc. and includes patients whose tumors are advanced and have not responded to standard treatments or for whom no standard options exist. The study involves three parts: Part A focuses on dose escalation where patients receive increasing doses of NDI-219216 daily in 28-day cycles to find the best dose. Part B randomizes patients into up to three dose groups determined from Part A to further evaluate the treatment daily in 28-day cycles. Part C enrolls patients with specific tumor biomarkers (dMMR/MSI-H) using the optimal dose from Part B. Participants take NDI-219216 orally every day throughout these cycles. Participants visit the clinic six times during the first 28-day cycle, twice in the second cycle, and then monthly for checkups and tests while on treatment. After finishing treatment, there is an end-of-treatment visit and a follow-up that can be done by phone. Patients keep a diary to track their tablet intake and any symptoms. Researchers assess safety by monitoring side effects, tumor response using imaging criteria, and measure drug levels in the blood at scheduled times during the first treatment cycle. The study may last up to 17-18 months depending on the part of the trial.

A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.