This is a Phase 1/2 study to evaluate the maximum tolerated dose, safety and efficacy of BEY1107 in combination with capecitabine in patients with metastatic colorectal cancer refractory or intolerant to standard of care (SoC).
In Phase 1, patients who experienced treatment failure of colorectal cancer with the second-line or beyond standard chemotherapy will be enrolled at each dose level of BEY1107 in combination with Capecitabine. Phase 2 will be conducted after RP2D is determined on the Phase 1 results.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
Administer once daily, PO, 3-week continuous dose.
Administer twice daily, PO, 2-week continuous dose, followed by 1-week rest period.
Seoul National University Hospial
Seoul, Jongro-go, South Korea
RECRUITINGMaximum Tolerated Dose(MTD) assessed by investigator following administration of BEY1107 in combination with Capecitabine
MTD will be assessed based on adverse events(including DLT assessment), vital signs, 12-lead ECG, laboratory tests, etc.
Time frame: From baseline up to disease progression, approximately 54 weeks
Objective Response Rate(ORR)(Phase 2) assessed by investigator following administration of BEY1107 in combination with Capecitabine
ORR defined as proportion of subjects with a overall response of CR or PR
Time frame: From baseline up to disease progression, approximately 54 weeks
Pharmacokinetic(PK) of Maximum Serum Concentration (Cmax) of BEY1107 in combination with Capecitabine
Plasma concentrations at each time point and PK parameters Cmax of BEY1107 will be assessed in the PK sampling cohort
Time frame: From baseline up to 24 hour post-dose
Pharmacokinetic of Time to Reach Maximum Serum Concentration (Tmax) of BEY1107 in combination with Capecitabine
Plasma concentrations at each time point and PK parameters Tmax of BEY1107 will be assessed in the PK sampling cohort
Time frame: From baseline up to 24 hour post-dose
Pharmacokinetic of Area Under the Serum Concentration-Time Curve Up to Last Quantifiable Time (AUClast) of BEY1107 in combination with Capecitabine
Plasma concentrations at each time point and PK parameters AUClast of BEY1107 will be assessed in the PK sampling cohort
Time frame: From baseline up to 24 hour post-dose
Progression-free survival(PFS) assessed by investigator following administration of BEY1107 in combination with Capecitabine
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PFS is defined as the time from the start of study treatment to the date of the first documentation of objective PD or death due to any cause, whichever is earlier
Time frame: From baseline up to disease progression, approximately 24 months
Disease control rate(DCR) assessed by investigator following administration of BEY1107 in combination with Capecitabine
DCR is defined as the proportion of participants who achieved a confirmed best overall response (BOR) of complete response (CR), partial response (PR), or stable disease (SD)
Time frame: From baseline up to approximately 24 months