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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
502
HS-20110 for IV infusion of various dosage in combination with Bevacizumab+5-FU/leucovorin administered in Q2W doseing cycles
HS-20110 for IV infusion of various dosage in combination with Bevacizumab+Oxaliplatin+5-FU/leucovorin administered in Q2W doseing cycles
HS-20110 for IV infusion of various dosage in combination with Bevacizumab+Oxaliplatin+Capecitabine administered in Q3W doseing cycles
Sun Yat-sen University Cancer Center
Guangzhou, China
RECRUITINGMaximum tolerated dose (MTD) or maximum applicable dose (MAD)
Time frame: From day 1 to one month after the last dose in Phase 1b
Recommended phase 2 dose (RP2D)
Time frame: From day 1 to one month after the last dose in Phase 1b
Objective response rate (ORR) as per RECIST v1.1
Time frame: From day 1 to 3 months after the last patient enrolled in Phase 2
Incidence of adverse events (AEs), serious adverse events (SAEs), AEs leading to dose modification or permanent discontinuation, and specific laboratory abnormalities
Time frame: From the first dose until 90 days after the last dose
Objective response rate (ORR)
Time frame: From first dose until 3 years after last dose
Incidence of anti-HS-20110 antibody (ADA)
Time frame: From the first dose until 90 days after the last dose
Drug concentrations of the three components of HS-20110 (including antibody-drug conjugates, total antibody, and payload)
Time frame: From the first dose until 90 days after the last dose
disease control rate (DCR)
Time frame: From first dose until 3 years after last dose
duration of response (DoR)
Time frame: From first dose until 3 years after last dose
progression-free survival (PFS)
Time frame: From first dose until 3 years after last dose
overall survival (OS)
Time frame: From first dose until 3 years after last dose
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