A Phase 1/2 Study of VIO-01 in Participants With Recurrent Solid Tumors

Exclusion Criteria

• •4. Participants with hormone receptor-positive (estrogen and/or progesterone receptor-positive) disease must have received and progressed on at least one endocrine therapy (adjuvant or metastatic) or have disease that the treating physician believes to be inappropriate for endocrine therapy. Endocrine therapy must have been completed at least 7 days before study treatment.
• •5. Participants with ER+ tumors should have progressed on prior CDK4/6 inhibitors (in addition to hormonal therapy) to be eligible.
• •6. Participants with triple negative breast cancer (TNBC) should have received sacituzumab prior to study enrollment.
• •4. Willingness to provide pre-treatment and on-treatment biopsies.
• •The following criteria must be checked at the time of screening and at baseline. If ANY exclusion criterion applies, the participant must not be included in the study:
• •1. Phase 2 Only: Have received more than one prior line of therapy in metastatic setting.
• •Note: Phase 1 has no limits for prior lines of therapy.
• •2. Participants with neurologic disorders such as Guillain-Barré syndrome (GBS), myasthenia gravis (MG), Parkinson's disease, amyotrophic lateral sclerosis (ALS), seizure disorder, multiple sclerosis (MS), or other chronic neurologic condition.