Study to Assess GTAEXS617 in Participants With Advanced Solid Tumors

Eligibility Criteria

• * Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
• * Life expectancy \> 3 months.
• * One of the following histologically or cytologically confirmed advanced solid tumors: head and neck squamous cell carcinoma (HNSCC), pancreatic adenocarcinoma, non-small cell lung cancer (NSCLC), breast carcinoma (hormone receptor-positive \[HR+\] and Human Epidermal Growth Receptor 2 negative \[HER2-\] that has progressed to a prior treatment with Cluster of Differentiation 4 \[CD4\] / Cyclin-Dependent Kinase 6 \[CDK6\] inhibitor), or platinum-resistant high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancers (HGSOC).
• * Must have disease that is advanced (ie, surgery or radiotherapy are not considered to be potentially curative), recurrent, or metastatic following SoC treatments.
• * Adequate hematological, liver, and renal function.
• * Must have tumor lesion(s) or metastases amenable to biopsy, excluding bone metastases.
• * Active and clinically significant (CS) infection.
• * Refractory nausea and/or vomiting, chronic gastrointestinal disease, or previous significant bowel resection, with CS sequelae that would preclude adequate absorption of GTAEXS617.
• * Symptomatic central nervous system (CNS) malignancy or metastases.
• * Concurrent active or previous malignancy.
• * Prior organ or allogeneic stem-cell transplantation.
• * Moderate or severe cardiovascular disease.
• * Received anticancer therapy within 28 days or 5 half-lives (whichever is shorter) before the first dose of the study treatment.
• * Received treatment with known strong/moderate inhibitors and/or strong inducers of cytochrome P450 3A isoform subfamily (CYP3A) within 14 days or 5 half-lives before the first dose of study treatment.
• * Received treatment with known inhibitors or inducers of P-glycoprotein (P-gp) or breast cancer resistance protein (BCRP) within 14 days or 5 half-lives before the first dose of study treatment.
• * Received treatment with known substrates of organic anion transporting peptide 1B3 (OATP1B3) or BCRP within 14 days or 5 half-lives before the first dose of study treatment.
• * Unresolved or unstable serious toxic side-effects of prior chemotherapy or radiotherapy
• * Has had or is scheduled to have major surgery \<28 days prior to the first dose of study treatment.