Study of AVZO-021 in Patients With Advanced Solid Tumors

Eligibility Criteria

• 1. Male or female aged ≥18 years old at screening with Eastern Cooperative Oncology Group (ECOG) 0-1.
• 2. Disease-related inclusion criteria by study phase and part:
• 3. No more than 2 prior cytotoxic chemotherapy regimens for locally advanced/metastatic disease (prior chemotherapy in the adjuvant or neoadjuvant setting allowed if \>12 months prior to starting AVZO-021 treatment and is not considered a prior line).
• 4. Measurable disease as determined by RECIST version 1.1.
• 5. Adequate bone marrow and organ function.
• 6. Ability to swallow capsules or tablets.
• 1. Received an investigational agent or anticancer therapy within 2 weeks, or 5 half-lives of the drug, whichever is shorter, prior to planned start of AVZO-021.
• 2. Received any CDK2 inhibitor, protein kinase membrane associated tyrosine/threonine 1 (PKMYT1) inhibitor, or WEE1 inhibitor anticancer therapy.
• 3. Undergone major surgery within 4 weeks prior to planned start of AVZO-021.
• 4. Received radiotherapy for palliation within 7 days of the first dose of study treatment, unless specified otherwise in the protocol.
• 5. Active CNS metastases or confirmed leptomeningeal disease are not eligible.
• 6. Unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grade \>1 at the time of starting study treatment.
• 7. Clinically unstable cardiac function as described in the protocol.
• 8. Any active or chronic infection/disease that compromises the immune system.
• 9. Current treatment with strong or moderate cytochrome P450 (CYP)3A4 inhibitors or inducers.
• 10. Active second malignancy unless in remission with life expectancy \> 2 years and with documented sponsor approval.
• 11. Pregnancy, lactation, or plans to breastfeed during the study or within 6 months of the last dose of study intervention.