A Study to Evaluate the Safety, Pharmacokinetics, and Anti-Tumor Activity of RO7589831 in Participants With Advanced Solid Tumors
Advanced Solid Tumors
About this trial
This is an interventional treatment trial for Advanced Solid Tumors focused on measuring Deficient mismatch repair, dMMR, Microsatellite instability, MSI
Eligibility Criteria
Inclusion Criteria: Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 Have a locally confirmed microsatellite instability (MSI) and/or deficient mismatch repair (dMMR), histologically or cytologically documented advanced (unresectable and/or metastatic) solid tumor Have received and then progressed following or are intolerant to at least 1 standard treatment regimen in the advanced setting Presence of measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 Life expectancy of at least (≥)12 weeks Availability of formaldehyde-fixed paraffin-embedded (FFPE) archival tumor tissue for submission to Sponsor/central laboratory for retrospective central testing; for participants without archival tissue, a biopsy from either primary or metastatic tumor lesion, deemed medically feasible, must be taken Adequate hematologic, end-organ, and cardiovascular function, as defined in the protocol Exclusion Criteria: Inability or unwillingness to swallow pills Malabsorption syndrome or other condition that would interfere with enteral absorption Known hypersensitivity or intolerance to ingredients from the study drug formulation including patients with rare genetic disorders such as galactosaemia, glucose-galactose intolerance or congenital lactase deficiency Known uncontrolled central nervous system (CNS) metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control) and/or carcinomatous meningitis Known active or uncontrolled bacterial, viral, fungal, mycobacterial (including but not limited to tuberculosis and atypical mycobacterial disease), parasitic, or other infection (excluding fungal infections of nail beds), or any major episode of infection requiring treatment with intravenous antibiotics or hospitalization within 2 weeks prior to the start of drug administration (related to the completion of the course of antibiotics, except if for tumor fever) or 6 months for any intracranial abscess Has a positive test at screening for hepatitis B virus, hepatitis C virus, or for human immodeficiency virus (HIV), per local diagnostic standard and in accordance with local laws and regulations Uncontrolled diabetes or symptomatic hyperglycemia (i.e., well controlled defined as a screening hemoglobin A1c <8% and no urinary ketoacidosis) Alcohol or drug dependence or abuse Patients with known Werner (WRN) syndrome Prior treatment with any WRN helicase inhibitor Pregnancy, breastfeeding, or intention of becoming pregnant during the study
Sites / Locations
- City of HopeRecruiting
- City of Hope at Irvine LennarRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Part I: RO7589831 Dose Escalation
Part II: RO7589831 Dose Expansion