Actively Recruiting
A Study to Evaluate Safety and Efficacy of BEY1107 in Combination with Capecitabine in Patients with Metastatic Colorectal Cancer
Led by BeyondBio Inc. · Updated on 2025-03-10
27
Participants Needed
1
Research Sites
278 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Study to Evaluate Safety and Efficacy of BEY1107 in Combination with Capecitabine in Patients with Metastatic Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult males and females aged over 19 years at the time of consent
- Diagnosed with colorectal cancer by tissue or cell analysis
- Have metastatic lesions that cannot be surgically removed
- Experienced treatment failure with second-line or later standard chemotherapy including fluoropyrimidine, oxaliplatin, and irinotecan
- Have at least one measurable or evaluable tumor lesion according to RECIST v1.1
- Have an ECOG performance status of 0 or 1
- Women of childbearing potential who are not surgically sterile must agree to use contraception until 6 months after end of treatment and show evidence of infertility
- Men who have not had vasectomy must agree to use contraception until 3 months after end of treatment
- Able and willing to provide informed consent and comply with study requirements
You will not qualify if you...
- Received radiation, chemotherapy, or biological therapy including hormone therapy recently
- Had surgery with general anesthesia within 4 weeks before screening
- Have symptomatic brain metastasis
- Have peripheral neuropathy
- Have gastrointestinal surgery or conditions preventing absorption or oral drug intake
- Have systemic disease unsuitable for anticancer treatment as judged by investigator
- Have cardiovascular disease at screening
- Have history of other cancers except basal cell skin cancer, cervical carcinoma in situ, or treated papillary thyroid cancer within 5 years
- Have gastrointestinal bleeding or ulcers
- Have dihydro-pyridine dehydrogenase (DPD) deficiency
- Have galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- Are allergic to BEY1107, capecitabine, or 5-FU
- Are HIV positive
- Have positive HBV or HCV results
- Have acute or severe infections
- Currently taking Sorivudine or brivudine
- Currently taking or recently discontinued (within 7 days) tegafur, gimeracil, and oteracil potassium
- Currently taking Rifampin or azole antifungal drugs
- Have abnormal lab results indicating inadequate bone marrow, kidney, or liver function
- Are pregnant, breastfeeding, or have a positive pregnancy test
- Have life expectancy less than 12 weeks
- Received other investigational products within 4 weeks prior to screening
- Deemed ineligible by investigator for participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Seoul National University Hospial
Seoul, Jongro-go, South Korea, 03080
Actively Recruiting
Research Team
B
BeyondBio Inc.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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