A Phase I Study to Evaluate the Safety, Tolerability, and PK of HLX37 in Advanced/Metastatic Solid Tumors

Before the trial, fully understand the content, process and possible adverse reactions of the trial, sign the informed consent form, voluntarily participate in the trial, and be able to complete the research in accordance with the requirements of the trial protocol.

At the time of signing the ICF, the applicant must be at least 18 years old and no more than 75 years old, with no gender restrictions.

part 1 of Stage Ia enrolled subjects with advanced or metastatic solid tumors confirmed by histology or cytology, who had failed at least one standard systemic treatment in the advanced or metastatic stage of the disease (subjects who had received neoadjuvant or adjuvant therapy, if disease progression or recurrence occurred within 6 months after the end of treatment) Then this treatment plan will be regarded as a failure of standard treatment, or there is currently no effective standard treatment method.

Within 4 weeks before the first administration, at least one measurable lesion was present according to the efficacy evaluation criteria of RECIST 1.1. For patients who have received radiotherapy before, if the lesion can be measured according to RECIST v1.1 and there is objective evidence proving significant progression after radiotherapy, the lesion that has undergone radiotherapy can be regarded as the target lesion. Brain metastases cannot be used as target lesions.