Primary Outcomes:

Primary Outcome 1 - Measure: Number of participants with adverse events (AEs)

Primary Outcome 1 - Time Frame: up to 3 years

Primary Outcome 2 - Measure: Number of participants with dose limiting toxicities (DLTs)

Primary Outcome 2 - Time Frame: 21 days

Condition:

• Solid Tumors

Eligibility

Criteria:
Inclusion Criteria:

- Participants (male or female) ≥18 years of age

- Participants who have advanced solid tumors that have failed, are intolerant to, or
are considered ineligible for standard of care anticancer treatments including
approved drugs for oncogenic drivers in their tumor type

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

- Participants in the Dose-Expansion Component must have molecular aberrations in the
mTOR pathway

- Adequate hematologic, hepatic and renal function

Exclusion Criteria:

- Known or suspected leptomeningeal or brain metastases or spinal cord compression

- Primary central nervous system (CNS) tumors

- Clinically significant cardiac disease

- Active, clinically significant interstitial lung disease or pneumonitis

- Subjects with abnormal fasting glucose, type 1 diabetes, or uncontrolled type 2
diabetes are excluded.

- Subjects with stomatitis or mucositis of any grade
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No