Shanghai Henlius Biotech
This study is an open-label first-in-human phase I clinical study to evaluate the safety, tolerability, and pharmacokinetic characteristics of HLX43 in patients with advanced/metastatic solid tumors.
This study is an open-label first-in-human phase I clinical study to evaluate the safety, tolerability , and pharmacokinetic characteristics of HLX43 with escalated doses in the treatment of patients with advanced/metastatic solid tumors. In the phase Ia of this study, a 3 + 3 dose escalation method will be adopted, and the patients will be administered with HLX43 at different doses via intravenous infusion. The DLT observation period lasts for 3 weeks after the first administration of HLX43. In phase Ib of this study, The Safety Review Committee will recommend dose groups for expansion base…
Inclusion Criteria: 1. 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; 2. ≥ 18 years and ≤ 75 years at the time of signing the ICF, male or female; 3. In phase Ia, enroll patients with histologically or cytologically confirmed advanced/metastatic malignant solid tumors, who are refractory to standard treatment, or for which no standard treatment is available; In phase Ib Cohort 1: enroll patients w…
Patients with good tolerability and well controlled disease will receive the treatment once every 3 weeks (Q3W), until progressive disease (PD) without any clinical benefit, initiation of other anti-tumor therapies, death, intolerable toxicity, or withdraw the informed consent (whichever occurs first).
All participants will receive serplulimab (300 mg Q3W) via intravenous infusion (IV) until PD without clinical benefits, initiation of new anti-tumor therapy, death, intolerable toxicity, or withdrawal of informed consent (whichever occurs first), and serplulimab will be administered for up to 2 years (35 dosing cycles).