Metastatic Colorectal CancerPhase 1/2NCT05093907
A Study to Evaluate Safety and Efficacy of BEY1107 in Combination with Capecitabine in Patients with Metastatic Colorectal Cancer
A Phase 1/2 study testing BEY1107 and Capecitabine in people with Metastatic Colorectal Cancer, run by BeyondBio Inc. at 1 site in South Korea.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- BEY1107 and Capecitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteSouth Korea
- Study dates
- 31 Aug 2021to 31 Dec 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult males and females aged over 19 years or older at the time of Informed Consent.
- Histopathologically or cytologically diagnosed with colorectal cancer.
- Patients with unresectable metastatic lesion(s).
- Patients who experienced treatment failure of colorectal cancer with the second-line or beyond standard chemotherapy (including fluoropyrimidine, oxaliplatin and irinotecan).
- Subjects who have at least one measurable or evaluable lesion as per RECIST v1.1.
- Subjects with ECOG performance status 0 or 1.
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- 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.
- 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.
- 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 cannot join
- Patients who received radiation therapy, chemotherapy or biological agent including hormone therapy recently.
- Subjects who had a surgery with general anesthesia within 4 weeks of screening.
- Subjects with symptomatic brain metastasis.
- Subjects with peripheral neuropathy.
- Subjects who had findings of affecting absorptin of the IP with gastrointestinal surgery or impossible oral drug administration.
- Subjects with systemic disease not suitable for anticancer agent administration at the discretion of the investigator.
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- Subjects who had a cardiovascular disease as of screening.
- 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.
- Gastrointestinal bleeding or ulcer.
- Dihydro-Pyridine Dehydrogenase (DPD) deficiency.
- Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
- Hypersensitivity to the ingredient(s) of the investigational product (BEY 1107) or capecitabine, 5-FU (fluorouracil).
- HIV Positive.
- Ineligible result of HBV, HCV by the investigator.
- Acute or severe infection.
- Subjects who take a Sorivudine or brivudine in combination.
- Subjects who take a combination of tegafur, gimeracil and oteracil potassium or discontinue within 7 days at the screening.
- Subjects who take a Rifampin and azole class antifungal drugs in combination.
- Subjects who has labortory findings of inadequate bone marrow, kidney and liver function.
- Pregnant women, breastfeeding women, or positive findings on the pregnancy test at screening.
- Subjects with life expectancy of less than 12 weeks by the investigator.
- Subjects who had been administered other IP within 4 weeks prior to screening.
- Subjects determined by the investigator to be ineligible for participation in this trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospial
Seoul, Jongro-go, 03080
Beyondbio Inc., +82-42-716-0020, clicaltrials@beyondbio.co.kr
About this study
Official title: 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 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).
Read the detailed description
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.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- BEY1107, Capecitabine
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BEY1107Drug
Administer once daily, PO, 3-week continuous dose.
CapecitabineCombination product
Administer twice daily, PO, 2-week continuous dose, followed by 1-week rest period.
| Study group | Role | What they receive |
|---|---|---|
| BEY1107 + Capecitabine | Experimental | Administer BEY1107 in combination with Capecitabine, 3-weeks as 1 cycle. Receives: Drug: BEY1107; Combination Product: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: From baseline up to disease progression, approximately 54 weeks
Secondary outcomes (5)
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
Measured: From baseline up to 24 hour post-dose
Pharmacokinetic of Time to Reach Maximum Serum Concentration (Tmax) of BEY1107 in combination with Capecitabine
Plasma concentrations at each time point and PK parameters Tmax of BEY1107 will be assessed in the PK sampling cohort
Measured: 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
Measured: 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
Measured: 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)
Measured: From baseline up to approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start31 Aug 2021
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BeyondBio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05093907
- Sponsor's protocol ID
- BEY-2021-01
- Status last verified
- Mar 2025
- First submitted
- 16 Sep 2021
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05093907
- Acronym / sponsor ID
- BEY-2021-01
- Conditions
- Metastatic Colorectal Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- BeyondBio Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Aug 2021 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BEY1107 + Capecitabine | Experimental | Drug: BEY1107, Combination Product: CapecitabineAdminister BEY1107 in combination with Capecitabine, 3-weeks as 1 cycle. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adult males and females aged over 19 years or older at the time of Informed Consent.
- Histopathologically or cytologically diagnosed with colorectal cancer.
- Patients with unresectable metastatic lesion(s).
- Patients who experienced treatment failure of colorectal cancer with the second-line or beyond standard chemotherapy (including fluoropyrimidine, oxaliplatin and irinotecan).
- Subjects who have at least one measurable or evaluable lesion as per RECIST v1.1.
Key exclusion criteria (23 listed)
- Patients who received radiation therapy, chemotherapy or biological agent including hormone therapy recently.
- Subjects who had a surgery with general anesthesia within 4 weeks of screening.
- Subjects with symptomatic brain metastasis.
- Subjects with peripheral neuropathy.
- Subjects who had findings of affecting absorptin of the IP with gastrointestinal surgery or impossible oral drug administration.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BEY1107Administer once daily, PO, 3-week continuous dose. | Drug | BEY1107 + Capecitabine |
| CapecitabineAdminister twice daily, PO, 2-week continuous dose, followed by 1-week rest period. | Combination product | BEY1107 + Capecitabine |
Primary outcome
Maximum Tolerated Dose(MTD) assessed by investigator following administration of BEY1107 in combination with Capecitabine
Time frame: From baseline up to disease progression, approximately 54 weeks
MTD will be assessed based on adverse events(including DLT assessment), vital signs, 12-lead ECG, laboratory tests, etc.
Objective Response Rate(ORR)(Phase 2) assessed by investigator following administration of BEY1107 in combination with Capecitabine
Time frame: From baseline up to disease progression, approximately 54 weeks
ORR defined as proportion of subjects with a overall response of CR or PR
5 secondary outcomes
Pharmacokinetic(PK) of Maximum Serum Concentration (Cmax) of BEY1107 in combination with Capecitabine
Time frame: From baseline up to 24 hour post-dose
Pharmacokinetic of Time to Reach Maximum Serum Concentration (Tmax) of BEY1107 in combination with Capecitabine
Time frame: 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
Time frame: From baseline up to 24 hour post-dose
Progression-free survival(PFS) assessed by investigator following administration of BEY1107 in combination with Capecitabine
Time frame: From baseline up to disease progression, approximately 24 months
Disease control rate(DCR) assessed by investigator following administration of BEY1107 in combination with Capecitabine
Time frame: From baseline up to approximately 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BEY1107 and Capecitabine in people with Metastatic Colorectal Cancer, run by BeyondBio Inc. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BeyondBio Inc. (+82-42-716-0020, clinicaltrials@beyondbio.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose(MTD) assessed by investigator following administration of BEY1107 in combination with Capecitabine (time frame: From baseline up to disease progression, approximately 54 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2025.