Study on ERAS-601 for People with Chordoma

Inclusion Criteria

• Must be 18 years or older.
• Have a confirmed diagnosis of chordoma that is not a dedifferentiated or poorly differentiated subtype.
• The cancer must be getting worse, as shown by a 20% increase in size between any two scans in the last 9 months.
• Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
• Have recovered from any significant side effects of recent treatments.
• Meet specific blood test criteria, including:
  • Neutrophil count of at least 1.5 x 10^3/mL
  • Platelet count of at least 75 x 10^3/mL without bleeding symptoms
  • Hemoglobin level greater than 9 g/dL
  • Normal levels of electrolytes, or corrected if needed
  • Liver enzymes (AST and ALT) within specified limits
  • Total bilirubin within specified limits, except for those with Gilbert Syndrome
  • Kidney function within specified limits
• Women of childbearing potential must have a negative pregnancy test before starting the study.
• Women and men of childbearing potential must agree to use effective contraception during the study and for 120 days after the last dose.
• Willing to attend all study visits and complete required assessments and questionnaires.

Exclusion Criteria

• Have previously been treated with a SHP2 inhibitor.
• Have certain genetic mutations (PTPN11 mutations).
• Are currently receiving another treatment that could affect the study results.
• Have had cancer treatment within 21 days or 5 half-lives, whichever is shorter.
• Have had radiation treatment within 14 days before starting the study.
• Have used certain medications or supplements that affect the liver enzyme CYP3A4 within 7 days before starting the study.
• Have a history of calcium or phosphate imbalance or abnormal tissue calcification.
• Have digestive issues that could affect drug absorption.
• Have an untreated or uncontrolled infection that requires treatment.
• Have certain eye conditions that affect the retina or cornea.
• Have any medical or psychiatric condition that could affect safety or the study results.
• Have not fully recovered from previous surgery.
• Are pregnant, breastfeeding, or planning to have children during the study and for 120 days after the last dose.
• Have another active cancer that could affect safety or the study results.