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;
Single group
HLX48
DrugEGFR/c-MET Bispecific Antibody-Drug Conjugate
The Dose-Limiting Toxicity (DLT) of HLX48 within 21 days after the first Administration
DLT refers to the AEs that are determined to be related to the investigational product by the investigator, whose severity will affect the escalation of dose level. In this study, the DLT observation period lasts for 21 days after the first administration of HLX48.
The maximum tolerated dose (MTD) of HLX48
The highest dose level, at which DLT is observed in no more than one of 6 evaluable patients, is defined as MTD of HLX48
Objective response rate (ORR)
Percentage of participants with complete response (CR) and partial response (PR) based on investigator assessment.
Duration of response (DOR)
Length of time response continued based on investigator's assessment.
Progression-free survival (PFS)
The PFS is defined as the time from the date of enrollment to the date of the first objective documentation of disease progression (as per RECIST v1.1) or death due to any cause,whichever occurred first.
Overall survival (OS)
Time from the date of enrollment to the date of death for any cause.
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