A Phase I/IIa Trial of NVG-222 in Participants with Solid Tumours.

• Research type

  Research Study

• Full title

  A Cancer Research UK Phase I/IIa, Dose Escalation and Expansion Trial of NVG-222, an AutoRegulating, Half-Life Extended Bispecific ROR1-directed CD3 T-cell Engager, Given in Participants with Solid Tumours.

• IRAS ID

  1012743

• Contact name

  Stuart Smith

• Contact email

  stuart.smith@cancer.org.uk

• Sponsor organisation

  Cancer Research UK

• ISRCTN Number

  ISRCTN13633989

• Research summary

  In this clinical trial, researchers are testing a drug called NVG-222. NVG-222 is a type of drug called a bispecific T-cell engager. This means that it works by recognising and attaching to cancer cells and also to immune cells in the body called T-cells (it is called ‘bispecific’ because it attaches to these 2 different types of cells). This should create a link that helps the T-cells to attack and kill the cancer cells. NVG-222 has been designed to work by attaching to a protein called ROR1 that is found in high levels on some cancers, and to a protein called CD3 that is found on T cells. NVG-222 contains an ‘off-switch’ and is designed turn itself off if there are early signs of side effects.
  The main aims of the clinical trial are to find out:
  1. The best dose of NVG-222 that can be given safely to participants in the trial.
  2. What the side effects of NVG-222 are.
  3. What happens to NVG-222 inside the body.
  4. Whether NVG-222 can shrink cancer.
  Patients aged 18 years and over with solid tumours that are expected to have ROR1 proteins on their cancer cells can participate. Patients must have cancer that has come back (relapsed) or does not respond to standard treatment (refractory), or for which the Investigator doesn’t think any standard treatment is right for the patient, or the patient decides not to have the treatment that has been offered to them.
  We aim to recruit up to 60 participants to the trial. This clinical trial is split into 2 phases. Phase I is the ‘dose escalation’ phase and is split into two parts ( Part I and II) and Phase II is the ‘dose expansion’ phase (Part III). Increasing the dose in Part I and II will be dependent on if are no serious side effects. Part III will start when the best dose of NVG-222 to give participants in the trial has been worked out and look at if NVG-222 works and whether it can shrink cancer.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  25/LO/0829

• Date of REC Opinion

  19 Jan 2026

• REC opinion

  Further Information Favourable Opinion