Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Shanghai Henlius Biotech
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Volunteer to participate in this clinical study; completely understand and know this study as well as sign the informed consent form (ICF);
Age ≥ 18 years;
Phase 1a dose escalation: patients must have histologically or cytologically confirmed malignant solid tumors which are advanced or metastatic, have failed prior standard treatment, and be intolerant or ineligible for standard therapy;
Phase 1b dose expansion: patients must have a histological or cytological diagnosis of Squamous Non-Small Cell Lung Cancer (EGFR H score ≥200 confirmed by central lab) which is advanced or metastatic, have failed prior standard treatment, and be intolerant or ineligible for standard therapy;
Measurable disease according to RECIST Version 1.1;
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
Expected survival 12 weeks;
Adequate organ function;
You may not be if
Systemic anti-cancer treatment or investigational agents in the 28 days prior to the first study dosing;
Patients who still have persistent ≥ grade 2 toxicities from prior therapies;
Active CNS metastasis;
History of any secondary malignancy in the past 5 years;
Active autoimmune disease;
Human immunodeficiency virus (HIV) infection;
Clareo Health | HLX35(EGFR×4-1BB Bispecific) in Patients With Advanced or Metastatic Solid Tumors
