Evaluating BEY1107 with Capecitabine for metastatic colorectal cancer

An Open-label, Single Center, Phase I/II Clinical Trial to Assess 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

This study is testing a new treatment called BEY1107 combined with capecitabine to see if it helps people with metastatic colorectal cancer who haven't had success with standard treatments.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 27 (estimated)
• Ages: 19 Years and up
• Sex: All
• Sponsor: BeyondBio Inc. (Industry-sponsored)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Seoul, Jongro-go)
• Trial ID: NCT05093907 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety and efficacy of BEY1107 in combination with capecitabine for patients with metastatic colorectal cancer who have not responded to standard treatments. The trial is divided into two phases: Phase 1 will determine the maximum tolerated dose and safety profile, while Phase 2 will evaluate the treatment's effectiveness based on the findings from Phase 1. Participants will be closely monitored for any adverse effects and treatment outcomes throughout the study.

Who should consider this trial

Good fit: Ideal candidates include adults over 19 years old with unresectable metastatic colorectal cancer who have failed previous chemotherapy treatments.

Not a fit: Patients with resectable metastatic lesions or those who have not yet undergone second-line chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with metastatic colorectal cancer who have limited alternatives.

How similar studies have performed: Other studies have explored similar combinations in colorectal cancer, but the specific use of BEY1107 is novel.

Eligibility criteria

Inclusion Criteria:

1. Adult males and females aged over 19 years or older at the time of Informed Consent.
2. Histopathologically or cytologically diagnosed with colorectal cancer.
3. Patients with unresectable metastatic lesion(s).
4. Patients who experienced treatment failure of colorectal cancer with the second-line or beyond standard chemotherapy (including fluoropyrimidine, oxaliplatin and irinotecan).
5. Subjects who have at least one measurable or evaluable lesion as per RECIST v1.1.
6. Subjects with ECOG performance status 0 or 1.
7. Women of childbearing potential who are not surgically sterile must consent to practice acceptable contraception until 6 months after the end of IP administration and also have the evidence of not being fertile.
8. Non-vasectomized men who consent to use an acceptable contraception by one-self and the partner until 3 months after the end of IP administration.
9. Patients who are fully informed of this trial, voluntarily decide to participate in the trial and provide written consent to comply with requirements for the trial.

Exclusion Criteria:

1. Patients who received radiation therapy, chemotherapy or biological agent including hormone therapy recently.
2. Subjects who had a surgery with general anesthesia within 4 weeks of screening.
3. Subjects with symptomatic brain metastasis.
4. Subjects with peripheral neuropathy.
5. Subjects who had findings of affecting absorptin of the IP with gastrointestinal surgery or impossible oral drug administration.
6. Subjects with systemic disease not suitable for anticancer agent administration at the discretion of the investigator.
7. Subjects who had a cardiovascular disease as of screening.
8. Subjects with history of malignancy other than basal cell carcinoma of the skin or cervical carcinoma in situ or papillary thyroid cancer appropriately treated within 5 years.
9. Gastrointestinal bleeding or ulcer.
10. Dihydro-Pyridine Dehydrogenase (DPD) deficiency.
11. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
12. Hypersensitivity to the ingredient(s) of the investigational product (BEY 1107) or capecitabine, 5-FU (fluorouracil).
13. HIV Positive.
14. Ineligible result of HBV, HCV by the investigator.
15. Acute or severe infection.
16. Subjects who take a Sorivudine or brivudine in combination.
17. Subjects who take a combination of tegafur, gimeracil and oteracil potassium or discontinue within 7 days at the screening.
18. Subjects who take a Rifampin and azole class antifungal drugs in combination.
19. Subjects who has labortory findings of inadequate bone marrow, kidney and liver function.
20. Pregnant women, breastfeeding women, or positive findings on the pregnancy test at screening.
21. Subjects with life expectancy of less than 12 weeks by the investigator.
22. Subjects who had been administered other IP within 4 weeks prior to screening.
23. Subjects determined by the investigator to be ineligible for participation in this trial.

Where this trial is running

Seoul, Jongro-go

• Seoul National University Hospial — Seoul, Jongro-go, South Korea (Recruiting)

Study contacts

• Study coordinator: BeyondBio Inc.

Conditions Metastatic Colorectal Cancer