Study on the Safety and Effects of AT-1965 in Patients with Advanced Solid Tumors

Inclusion Criteria

• Have a confirmed diagnosis of a solid tumor that cannot be surgically removed or has spread, and does not respond to standard treatments.
• Have at least one tumor that can be measured by scans.
• Have recovered from side effects of previous treatments to a mild level, except for hair loss.
• Be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
• Have adequate blood cell counts and organ function, including:
  • Hemoglobin level of at least 9.5 g/dL without recent transfusions.
  • Platelet count of at least 100,000 cells/L.
  • Neutrophil count of at least 1.5 x 10^9 cells/L without recent growth factor support.
  • Kidney function with creatinine clearance of at least 60 mL/min.
  • Liver function with bilirubin, AST, and ALT levels within specified limits.
• Women of childbearing potential must have a negative pregnancy test before starting treatment and agree to use effective contraception during the study and for three months after.
• Men with female partners of childbearing potential must agree to use birth control or abstain from intercourse during the study and for three months after.
• Must have completed any other clinical trials at least 30 days prior.
• Must have received the mRNA Covid-19 vaccine at least 28 days prior.
• Willing to avoid sun exposure and use protective measures if necessary.
• Able to understand and sign informed consent and agree to follow study requirements.

For Part B (TNBC patients only):

• Have metastatic triple-negative breast cancer and have received at least two prior treatments for advanced disease.
• Have tried all available FDA-approved therapies for TNBC with specific markers before joining this part of the study.

Exclusion Criteria

• Have uncontrolled or life-threatening medical conditions that could interfere with the study.
• Have unstable or severe medical conditions or psychiatric illnesses that increase risk.
• Have uncontrolled diabetes.
• Have a history of autoimmune diseases, except for certain resolved conditions.
• Have lung diseases like interstitial lung disease or pneumonitis.
• Have a history of blood disorders like hemolytic anemia.
• Have adrenal gland disorders.
• Have received a bone marrow or organ transplant.
• Have unresolved viral infections like HIV or hepatitis.
• Have significant heart disease or recent heart events.
• Have received recent cancer treatments or investigational drugs within specified timeframes.
• Have untreated or active central nervous system cancers.
• Have a history of other significant cancers.
• Require high-dose steroids or immunosuppressive medications.
• Have had severe immune-related side effects from previous treatments.
• Have received a live vaccine recently.
• Are pregnant, breastfeeding, or unwilling to stop breastfeeding during the study.
• Have uncontrolled infections requiring IV treatment.
• Are under 18 years old.
• Have a life expectancy of less than three months.
• Have current drug or alcohol abuse issues.
• Are deemed unsuitable for the study by the investigator.