RecruitingPhase 1Phase 2NCT05093907

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


Sponsor

BeyondBio Inc.

Enrollment

27 participants

Start Date

Aug 31, 2021

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called BEY1107 combined with capecitabine (an oral chemotherapy pill) in people with metastatic colorectal cancer that has not responded to at least two prior standard treatment regimens. **You may be eligible if...** - You have been diagnosed with colorectal cancer that has spread (metastatic) and cannot be removed by surgery - Your cancer progressed after at least two prior chemotherapy treatments including fluoropyrimidine, oxaliplatin, and irinotecan - You are 19 or older - You have at least one measurable tumor on scans - You are in reasonably good physical health (ECOG 0 or 1) - You are willing to use contraception if you can become pregnant or father a child **You may NOT be eligible if...** - You received chemotherapy, radiation, or biologic therapy recently (timeframe specified in the protocol) - You have significant heart, liver, or kidney problems - You are pregnant or breastfeeding - You have a history of serious allergic reactions to the study drugs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBEY1107

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

COMBINATION_PRODUCTCapecitabine

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


Locations(1)

Seoul National University Hospial

Seoul, Jongro-go, South Korea

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NCT05093907


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