A Phase Ib/II Clinical Study Evaluating HMPL-453 Tartrate as Monotherapy and in Combination With Chemotherapy or Toripalimab in Advanced Solid Tumors

Korábbi kezelés

• Patients who previously received selective FGFR targeting therapy;
• Concurrent participation in another interventional clinical study, excluding those in the follow-up period and have not recently received investigational intervention;
• Current or previous history of central nervous system (CNS) metastases；
• Current or previous history of retinal detachment；
• Received live vaccine within 30 days before the first dose of study drug(s);
• Those who have undergone major surgical procedures (craniotomy, thoracotomy or laparotomy) within 4 weeks prior to the first study treatment or who are expected to be in need of major surgery; those with unhealed wounds, ulcers or fractures.

Más betegség

• Known history of primary immunodeficiency;
• Patients with acute or chronic active hepatitis B or C infection;
• Known human immunodeficiency virus (HIV) infection and syphilis infection；
• Clinically significant cardiovascular disease such as congestive heart failure or arrhythmia；
• Uncontrolled hypertension despite optimal medical management；

Egyéb

• Female patients who are pregnant or lactating；
• Patients who in the opinion of the investigator may be unsuitable for participating in the study;

• Dose escalation phase: patients with histologically or cytologically confirmed locally advanced or metastatic solid tumor who progressed on or are intolerant of standard therapy;
• Dose expansion phase: patients with UC, GC/GEJ, or IHCC harboring specific FGFR gene alterations;
• Age 18 to 75 years;
• Those who are able to give written informed consent, and able to comply with protocol-specified visits and related procedures;
• Ability to swallow study drug;
• ECOG PS of 0 or 1;
• Measurable lesion according to RECIST v1.1, refer to the protocol;
• Adequate organ and bone marrow function;
• Life expectancy ≥ 12 weeks;
• Female patients or male patients with partners of childbearing potential must take effective contraceptive measures per the protocol.