Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BEY1107 + Capecitabine | Experimental | Administer BEY1107 in combination with Capecitabine, 3-weeks as 1 cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BEY1107 | Drug | Administer once daily, PO, 3-week continuous dose. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum 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. | 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 | From baseline up to disease progression, approximately 54 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From baseline up to 24 hour post-dose |
| Pharmacokinetic of Time to Reach Maximum Serum Concentration (Tmax) of BEY1107 in combination with Capecitabine |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| BeyondBio Inc. | Contact | +82-42-716-0020 | clinicaltrials@beyondbio.co.kr |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospial | Recruiting | Seoul | Jongro-go | 03080 | South Korea |
Not provided
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Capecitabine |
| Combination Product |
Administer twice daily, PO, 2-week continuous dose, followed by 1-week rest period. |
|
Plasma concentrations at each time point and PK parameters Tmax of BEY1107 will be assessed in the PK sampling cohort |
| 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 | From baseline up to 24 hour post-dose |
| Progression-free survival(PFS) assessed by investigator following administration of BEY1107 in combination with Capecitabine | 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 | 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) | From baseline up to approximately 24 months |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |