NCI-2022-04262

A Phase 1, Multicenter, Open-Label, Dose-Escalation, and Dose-Expansion Study of IO-202 in Combination with Pembrolizumab in Subjects with Advanced, Relapsed, or Refractory Solid Tumors

This is an early-stage, open-label, multicenter medical study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of IO-202, either alone (monotherapy) or in combination with pembrolizumab. IO-202 is an investigational drug called a bispecific T cell engager (BiTE). BiTEs are designed to link T cells, a type of immune cell, to cancer cells, which helps the immune system kill the cancer cells. Pembrolizumab is a type of immunotherapy drug called a PD-1 inhibitor. It helps the immune system attack cancer cells by blocking a protein called PD-1 that can sometimes hide cancer cells from the immune system. The study is open to adults with advanced, relapsed, or refractory solid tumors who have not received prior treatment with a BiTE or anti-PD-1 therapy. The study will be conducted in two parts:

Part 1: This is a dose-escalation phase, where researchers will determine the safest and most effective dose of IO-202, either alone or in combination with pembrolizumab.

Part 2: This is a dose-expansion phase, where researchers will further evaluate the safety and efficacy of IO-202 at the chosen dose from Part 1 in a larger group of patients with specific tumor types.

Early-stage: Early phase (phases I and II) studies help researchers determine: Whether a new treatment is safe, what its side effects are and the best dose of the new treatment.

Open-label: Patients know which treatments are being given to them

For more information about the trial, click the link below:

https://clinicaltrials.gov/ct2/show/NCT05309187

NCI-2022-04262

Clinical Trial Site: Sinai

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