A Study of AK138D1 Alone or in Combination With Ivonescimab in Advanced Breast Cancer

Korábbi kezelés

• Concomitant participation in another clinical study, unless it is a non-interventional clinical study or the follow-up period of an interventional study;
• Live vaccines or attenuated live vaccines administered within 4 weeks prior to the first dose, or planned to be administered during the study; use of inactivated vaccines is allowed;

Más betegség

• Untreated subjects with active hepatitis B or active hepatitis C;
• Known active pulmonary tuberculosis (TB); subjects with suspected active TB must undergo appropriate clinical assessment to rule out the presence of active disease;
• Known active syphilis infection;
• Subjects with known allergy to any component of any study drug; and with a history of known severe hypersensitivity reactions to other monoclonal antibodies;

Egyéb

• Presence of active central nervous system (CNS) metastases.
• Other reasons for ineligibility as evaluated by the investigator.

• The subject must sign the written informed consent form (ICF) voluntarily;
• At enrollment, aged ≥ 18 to ≤ 75 years, both males and females are eligible;
• ECOG performance status score of 0 or 1;
• Has a life expectancy of ≥ 3 months;
• At least 1 measurable lesion as per RECIST v1.1 that is suitable for repeated accurate measurement.
• Adequate organ function.