Clinical Trials

Inclusion Criteria:

- Male or female and ≥18 years-of-age at the time of signature of the informed consent

- Confirmed advanced solid tumors resistant or refractory to standard treatment

- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.

- Evaluable disease as per RECIST v1.1

- Next generation sequencing (NGS) report obtained in CLIA-certified or equivalent
laboratory demonstrating eligible tumor biomarkers.

- Submission of available tumor tissue or willingness to have a biopsy performed if safe
and feasible

- Acceptable hematologic and organ function at screening

- Negative pregnancy test for women of childbearing potential at Screening and prior to
first study drug.

- Ability to swallow and retain oral medications.

Exclusion Criteria:

- Prior therapy with an ATR or DNA-dependent protein kinase (DNA-PK) inhibitor.

- Chemotherapy, small molecule anticancer or biologic anticancer therapy given within 10
days or 5 half-lives (whichever is longer), prior to first dose of study drug.

- Use of radiotherapy (except for palliative reasons) within 7 days prior to first dose
of study drug.

- History or current condition, therapy, or laboratory abnormality that might confound
the study results, or interfere with the patient's participation for the full duration
of the study treatment.

- No other anticancer therapy is to be permitted while the patient is receiving study
treatment.

- Major surgery ≤28 days or minor surgical procedures ≤7 days prior to first study
treatment dose.

- Uncontrolled, symptomatic brain metastases.

- Uncontrolled high blood pressure

- History of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) diagnosis

- Presence of other known active invasive cancers.

- Pregnant or breastfeeding women.

- Psychological, familial, sociological, or geographical conditions that do not permit
compliance with the study protocol and/or follow-up procedures outlined in the
protocol.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 2/28/23. Questions regarding updates should be directed to the study team contact.