This study is an open-label first-in-human phase I clinical study to evaluate the safety, tolerability, and pharmacokinetic characteristics of HLX48 in patients with advanced/metastatic solid tumors.
Have a full understanding of the study content, process, and possible adverse reactions before the study, and sign the informed consent form (ICF); voluntarily participate in the study; be able to complete the study as per protocol requirements;
Aged ≥ 18 years and ≤ 75 years at the time of signing the ICF, male or female;
Participants with histologically or cytologically confirmed advanced/metastatic malignant solid tumors, who have failed or have no available standard treatment;
At least one measurable lesion as per RECIST v1.1 within 4 weeks prior to the first dose;
History of other malignant tumors within 2 years prior to first dose, except radically treated early-stage malignant tumors (carcinoma in situ or stage I tumors), such as cured cervical carcinoma in situ, non-melanoma skin cancer, ductal carcinoma in situ of the breast, and papillary thyroid carcinoma;
History of serious ocular diseases, including: (1) keratoconjunctivitis sicca; (2) severe keratopathy; (3) moderate or severe xerophthalmia;
History of (non-infectious) interstitial lung disease (ILD) requiring use of steroids, or current ILD, or suspected ILD that cannot be ruled out by imaging at screening;
Known history of severe allergic reactions to macromolecular protein preparations/monoclonal antibodies, or allergy to any component in the formulation of the investigational product; previous exposure to ADCs with topoisomerase I inhibitors as payload;
Shanghai Henlius Biotech
Lead sponsor