A Phase 1 Study of NDI-219216 in Patients with Advanced Solid Tumors

• Research type

  Research Study

• Full title

  A Phase 1 Open-label, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of NDI-219216 as a Single Agent in Patients with Advanced Solid Tumors with and without Microsatellite Instability and/or Deficient Mismatch Repair

• IRAS ID

  1011924

• Contact name

  Claudia Fehling

• Contact email

  claudia.fehling@nimbustx.com

• Sponsor organisation

  Nimbus Wadjet, Inc.

• Eudract number

  2025-522774-36

• Clinicaltrials.gov Identifier

  NCT06898450

• Research summary

  Reason for the study: This study will test an investigational medication called NDI-219216. NDI-219216 is an investigational medication because it has not been approved by health authorities to treat any condition. Research is ongoing into how it works and how safe it is.
  NDI-219216 is being tested to see if it can treat advanced solid tumours. Advanced solid tumours are cancers that have formed a mass in the body and that are unlikely to be cured or controlled with existing treatments. This study will try to find out more about the safety of NDI-219216, what the best dose could be, what the body does to NDI-219216, and if NDI-219216 may be helpful in treating advanced solid tumours. To do this, researchers will collect and analyse information about:
   What side effects people have when taking NDI-219216 and how bad they are.
   How much NDI-219216 can be found in the blood, how the amount of NDI-219216 in blood changes over time, and how the body breaks down NDI-219216.
   Any changes in blood markers when people take NDI-219216.
   If NDI-219216 has any effect on solid tumours.

  Treatment being studied: All participants in this study will be given NDI-219216. NDI-219216 will be given as tablets to be swallowed with a glass of water once every morning, at about the same time every day. Participants should not eat any food for 2 hours before and for 1 hour after taking the tablets. NDI-219216 will be given in “cycles” of 28 days each. The number of cycles a participant receives will depend on how their body reacts to NDI-219216 as well as their overall health and stability of their cancer.

  Study population: Only adult participants who are able and willing to provide written informed consent can take part in this study. All participants must have solid tumours that cannot be removed through surgery or that have spread to other parts of the body, and participants must have already tried existing treatments for their cancers.

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  25/SC/0292

• Date of REC Opinion

  15 Oct 2025

• REC opinion

  Further Information Favourable Opinion