AMG 410 Alone and in Combination With Other Agents in Participants With KRAS Altered Advanced or Metastatic Solid Tumors

Korábbi kezelés

• Active systemic infection or symptoms that indicate an acute and/or uncontrolled infection requiring IV antibiotics within 7days prior to the first dose of study treatment.
• Live and live-attenuated vaccines are prohibited within 28 days prior to the first dose of study treatment.
• Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, hormonal therapy, or investigational agent) within 28 days of first dose of study treatment.
• Toxicities from prior anti-tumor therapy (including radiotherapy) not having improved to at least Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade 1.
• Therapeutic or palliative radiation therapy within 2 weeks of first dose of study treatment.
• Major surgery within 28 days of first dose of study treatment.

Más betegség

• History of other malignancy within the past 5 years.
• History of arterial or venous thrombosis (eg, stroke, transient ischemic attack, pulmonary embolism, or deep vein thrombosis).
• History of solid organ transplant.
• Presence or history of any of the following viral infections: HIV, Hepatitis C, Hepatitis B, and active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
• History or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator, would pose a risk to participant safety.

Egyéb

• Untreated symptomatic central nervous system or leptomeningeal metastases.
• Uncontrolled pleural effusion and/or ascites.

• Age ≥ 18 years (or > legal age within the country if it is older than 18 years).
• Pathologically documented, locally-advanced or metastatic malignancy with any missense mutation in the KRAS gene or evidence of KRAS amplification using an analytically validated KRASWT amplification assay.
• Participants must have no standard of care treatment options or have actively refused such therapy.
• Able to swallow and retain per oral administered study treatment.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
• Disease measurable as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), as determined by the site investigator.
• Adequate organ function.
• Archival (formalin-fixed, paraffin-embedded [FFPE]) tumor tissue or block collected within 5 years before screening must be available. Participants without archived tumor tissue may undergo tumor biopsy before AMG 410 dosing (Day1).