Phase 1/2 Study for IPG7236 Combined With Toripalimab in Participants With Advanced Solid Tumors
Written informed consent must be obtained before any study procedure is performed.
Men or women 18 years of age or older.
Histologically or cytologically confirmed advanced or recurrent malignant solid tumors that are metastatic or unresectable. (Subjects must submit tumor tissue sections from within the past 5 years for CCR8 expression testing. For subjects without paraffin-embedded tissues, a fine-needle aspiration biopsy may be performed. Subjects who cannot provide tumor tissue sections or undergo biopsy are only eligible for inclusion during the dose escalation phase. During the dose expansion phase, CCR8 positivity must be known or tumor tissue sections must be provided with confirmed CCR8 expression.)
Subjects must have failed or been intolerant to standard antitumor therapy, or lack a standard treatment regimen, or be deemed by the investigator as currently unsuitable for standard therapy.
Primary malignant tumors of the central nervous system or malignant tumors associated with human immunodeficiency virus (HIV) .
Previous use of CCR8-targeted therapy.
Planned major surgery within 4 weeks prior to the first dose administration (excluding minor procedures such as vascular access placement, gastrointestinal/biliary stent placement, or biopsy);
Immunotherapy or biological therapy administered within 28 days prior to the initial administration;
Nanjing Immunophage Biotech Co., Ltd
Lead sponsor