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

March 6, 2025 updated by: BeyondBio Inc.

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
27

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: BEY1107 + Capecitabine
Administer BEY1107 in combination with Capecitabine, 3-weeks as 1 cycle.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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
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
From baseline up to disease progression, approximately 54 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pharmacokinetic(PK) of Maximum Serum Concentration (Cmax) of BEY1107 in combination with Capecitabine
Time Frame: From baseline up to 24 hour post-dose
Plasma concentrations at each time point and PK parameters Cmax of BEY1107 will be assessed in the PK sampling cohort
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
Plasma concentrations at each time point and PK parameters Tmax of BEY1107 will be assessed in the PK sampling cohort
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
Plasma concentrations at each time point and PK parameters AUClast of BEY1107 will be assessed in the PK sampling cohort
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
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
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
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)
From baseline up to approximately 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
BeyondBio Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 31, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 16, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 25, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 26, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BEY-2021-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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