A Study to Evaluate Safety and Efficacy of BEY1107 in Combination with Capecitabine in Patients with 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

A Study to Evaluate Safety and Efficacy of BEY1107 in Combination with Capecitabine in Patients with Metastatic Colorectal Cancer (NCT05093907) is a Phase 1 / Phase 2 interventional studying Metastatic Colorectal Cancer, sponsored by BeyondBio Inc.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Metastatic Colorectal Cancer, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 27 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Adult males and females aged over 19 years or older at the time of willing to sign a consent form. 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 You should be able to carry out daily activities with 0 level of ability (ECOG 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. Who Should NOT Join This Trial: 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DRUG

BEY1107

Administer once daily, PO, 3-week continuous dose.

COMBINATION_PRODUCT

Capecitabine

Administer twice daily, PO, 2-week continuous dose, followed by 1-week rest period.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Seoul National University Hospial

Seoul, Jongro-go, South Korea

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05093907), the sponsor (BeyondBio Inc.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05093907 clinical trial studying?

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). The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05093907?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05093907?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05093907. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05093907. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.