A Phase I Study of QL1604 for Advanced Solid Tumors

A Phase I Clinical Study to Evaluate Safety、 Tolerability, and Pharmacokinetics of QL1604 for the Treatment of Advanced Solid Tumors - A Phase Ic Preliminary Efficacy Expansion Study

In this study, patients with advance solid tumors will be treated with QL1604 monotherapy.

Key Inclusion Criteria:

• 18-75 years;
• At least one measureable lesion as defined per RECIST Version (v) 1.1
• Histologically or cytologically confirmed、failed to standard therapy or lack standard therapy(except immunotherapy) advanced solid tumors; for cervical cancer, only squamous carcinoma、adenocarcinoma、adenosquamous carcinoma could be enrolled； hepatocellular carcinoma could be enrolled by clinical diagnosis
• Adequate important organ function

Key Exclusion Criteria:

• Active autoimmune disease orautoimmune disease history
• Meningeal metastasis,or brain metastasis( except asymptomatic brain metastasis, or symptomatic brain metastasis but stable for more than 4 weeks after treatment, and have stopped systemic hormone treatment (prednisone of > 10 mg/day or equivalent hormone) for more than 2 weeks)
• Known hypersensitivity to protein macromolecules, and/or any of QL1604 excipients
• Radiotherapy, chemotherapy, hormone therapy, surgery, targeted therapy within 4 weeks prior to study drug (for micromolecule targeted therapy, within 2 weeks)
• Active hepaititis B or C infection
• Both HBsAg and anti-HCV Ab positive