HS-CA102N-103 is a Phase 2, randomized, open label study to evaluate efficacy, safety, and tolerability of CA102N combined with trifluridine/tipiracil (TAS-102) compared to bevacizumab combined with TAS-102 in subjects with metastatic colorectal cancer (mCRC) who failed the standard treatment (for eg, cancer that has relapsed after or is refractory to fluoropyrimidine, oxaliplatin and irinotecan-based chemotherapy).
HS-CA102N-103 is a Phase 2, randomized, open label study to evaluate efficacy, safety, and tolerability of CA102N combined with trifluridine/tipiracil (TAS-102) compared to bevacizumab combined with TAS-102 in subjects with metastatic colorectal cancer (mCRC) who failed the standard treatment (for eg, cancer that has relapsed after or is refractory to fluoropyrimidine, oxaliplatin and irinotecan-based chemotherapy). In this study, the safety, tolerability, and PFS of CA102N in combination with TAS-102 compared to bevacizumab combined with TAS-102 will be evaluated in up to 100 subjects with metastatic colorectal cancer who have previously received fluoropyrimidine, oxaliplatin, and irinotecan-based chemotherapy, an anti-vascular endothelial growth factor (VEGF) biological therapy, and if RAS wild-type mCRC, an anti-epidermal growth factor receptor (EGFR) therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
CA102N is a covalently bound conjugate of the biological polymer sodium hyaluronate (NaHA) and nimesulide (Nim)
TAS-102 is a cytotoxic combination treatment of 2 drugs: trifluridine, a thymidine-based nucleoside analogue, and tipiracil an inhibitor of thymidine phosphorylase.
Bevacizumab recombinant humanized monoclonal antibody that binds and neutralizes circulating vascular endothelial growth factor (VEGF)-A.
To evaluate the efficacy of CA102N in combination with trifluridine/tipiracil (TAS-102) by progression free survival (PFS) rate.
Time frame: 16 weeks after first treatment.
Number of subjects with treatment-related adverse events as assessed by NCI-CTCAE v5.0
Time frame: one year after first treatment.
Disease control rate (DCR)
To evaluate the efficacy of CA102N in combination with trifluridine/tipiracil (TAS-102) by disease control rate.
Time frame: 16 weeks after first treatment.
Overall response rate (ORR)
To evaluate the efficacy of CA102N in combination with trifluridine/tipiracil (TAS-102) by overall response rate.
Time frame: 16 weeks after first treatment.
Maximum Plasma Concentration [Cmax] of CA102N when used in combination with trifluridine/tipiracil (TAS-102)
Time frame: 16 weeks after first treatment.
To evaluate the efficacy of CA102N in combination with trifluridine/tipiracil (TAS-102) by overall survival (OS).
Time frame: one year after first treatment.
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