Evaluating BEY1107 with Capecitabine for metastatic colorectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: BeyondBio Inc.
• Email: clinicaltrials@beyondbio.co.kr
• Phone: +82-42-716-0020

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Becotatug Vedotin plus Pucotenlimab for EGFR-positive metastatic colorectal cancer

  This study tests whether combining becotatug vedotin with pucotenlimab can shrink tumors in adults with colorectal cancer that has returned or spread after at least two prior treatments and whose tumors express EGFR.

  Recruiting Phase 2 Fudan University · Shanghai, Shanghai Municipality · NCT07884188

• DEM301 in advanced colorectal cancer: a first-in-human test

  This first-in-human Phase 1 study tests DEM301 in adults with advanced metastatic colorectal cancer to see if it is safe, how it behaves in the body, and whether it shows any signs of activity.

  Recruiting at 2 sites Phase 1 DEM BioPharma, Inc. · Birtinya, Queensland and 1 other locations · NCT07805369

• Immunotherapy plus Simvastatin and Targeted Therapy with Chemotherapy for Advanced Colorectal Cancer

  This trial tests whether adding immune therapy (adbelimumab? actually Adebrelimab) with simvastatin and targeted therapy to standard chemotherapy helps people with metastatic colorectal cancer that is MSI-H/dMMR or MSS/pMMR depending on combination.

  Recruiting Phase 2 The First Affiliated Hospital with Nanjing Medical University · Nanjing, Jiangsu and 1 other locations · NCT07718490

• Fruquintinib treatment in adults with metastatic colorectal cancer in Poland

  This study looks at whether taking fruquintinib by mouth after prior therapies helps adults with metastatic colorectal cancer in Poland live longer before the cancer progresses and overall survival, while also considering quality of life.

  Recruiting at 3 sites Takeda · Poznan, Greater Poland Voivodeship and 9 other locations · NCT07623174

• Understanding why BRAF V600E colorectal cancer stops responding to targeted therapy

  This study tests why metastatic colorectal cancer with a BRAF V600E mutation stops responding to encorafenib and cetuximab, by collecting tissue, blood, and stool samples over time.

  Recruiting at 13 sites Swiss Cancer Institute · Aarau and 12 other locations · NCT07617610

• Second-line combination treatment for MSS metastatic colorectal cancer

  This trial will try folinic acid plus continuous 5-FU with liposomal irinotecan, sometimes combined with cetuximab or bevacizumab, as a second-line option for adults with MSS metastatic colorectal cancer who progressed on or cannot tolerate oxaliplatin-based therapy.

  Recruiting Phase 2 The First Hospital of Jilin University · Changchun, Jilin · NCT07559760

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.