A Trial of SHR-1701 in Subjects With Advanced Solid Tumors

A Phase 1, Open-Label, Multi-Center, Non-Randomized, Dose Escalation/Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of SHR-1701 in Subjects With Advanced Solid Tumors.

This is a dose-escalation and dose-expansion Phase 1 trial to evaluate the safety and tolerability of SHR-1701 in subjects with advanced solid tumors.

This is a two-part, open-label, multicenter, non-randomized, dose escalation, Phase 1 study of repeated doses of SHR-1701 in subjects with advanced solid tumors who have failed current standard anti-tumor therapies.

Inclusion Criteria:

• Diagnosed (histologically or cytologically) with solid tumors
• ECOG Performance Status of 0 or 1 at both the screening and baseline visits
• Life expectancy ≥12 weeks
• Adequate laboratory parameters
• Willing and able to comply with clinic visits and study-related procedures
• Provide signed informed consent

Exclusion Criteria:

• Known history of hypersensitivity to the study drug
• Prior malignancy active within the previous 2 years
• Any investigational or concurrent cancer therapy
• History of immunodeficiency including seropositivity
• Systemic antibiotics treatment for ≥ 7 days before the first dose
• A known history of allogeneic organ transplantation