A Phase Ib/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HS-20110 Combination Therapies in Patients With Advanced Colorectal Cancer.
This is a multicenter, open-label Phase Ib/II clinical study evaluating the safety, tolerability, pharmacokinetics (PK), and efficacy of the HS-20110 combination therapies in Patients with Advanced Colorectal Cancer. Rolling 6 design would be used to conduct dose escalation part of this study. This study consists of phase Ib and phase II. After RP2D was determined in phase Ib, then a phase II study will be conducted to further evaluate the efficacy, safety, tolerability, and PK of the HS-20110 combination therapies in Patients with mCRC.
• Males or females, aged ≥ 18 years.
• Participants with pathologically confirmed advanced Colorectal Cancer.
• Participants have at least 1 target lesion other than CNS lesions according to RECIST 1.1.
• MSI was tested to be non-MSI-H, and without BRAF V600E mutation.