Inclusion Criteria:
- Histologically confirmed diagnosis of a solid tumor malignancy harboring KRAS G12D
mutation in tumor tissue or ctDNA.
- Unresectable or metastatic disease.
- Patients must have received standard therapies appropriate for their tumor type and
stage; first-line treatment for PDAC for certain cohorts.
- Presence of tumor lesions to be evaluated per RECIST v1.1:
1. in the Phase 1 dose escalation cohorts, patients must have measurable or
evaluable disease.
2. in the Phase 1b and Phase 2 cohorts, patients must have measurable disease.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate organ function.
- Age ≥ 18 years
Exclusion Criteria:
- Active brain metastases or carcinomatous meningitis.
- Prior treatment with a KRAS G12D inhibitor (Phase 1b & Phase 2 only).
- History of significant hemoptysis or hemorrhage within 4 weeks of the first dose of
study treatment.
- History of intestinal disease, inflammatory bowel disease, major gastric surgery, or
other gastrointestinal conditions likely to alter absorption of study treatment or
result in inability to swallow oral medications.
- History of malignant small bowel obstruction.
- Cardiac abnormalities.
