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

NCT05093907 | Recruiting Phase 1

• 1 other identifier: BEY-2021-01
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  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

  From baseline up to 24 hour post-dose

• Pharmacokinetic of Time to Reach Maximum Serum Concentration (Tmax) of BEY1107 in combination with Capecitabine

  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

  From baseline up to 24 hour post-dose

• Progression-free survival(PFS) assessed by investigator following administration of BEY1107 in combination with Capecitabine

  From baseline up to disease progression, approximately 24 months

• Disease control rate(DCR) assessed by investigator following administration of BEY1107 in combination with Capecitabine

  From baseline up to approximately 24 months

Study Arms (1)

BEY1107 + Capecitabine

EXPERIMENTAL

Administer BEY1107 in combination with Capecitabine, 3-weeks as 1 cycle.

Drug: BEY1107; Combination Product: Capecitabine

Interventions

BEY1107 DRUG

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

BEY1107 + Capecitabine

Capecitabine COMBINATION_PRODUCT

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

BEY1107 + Capecitabine

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• BeyondBio Inc.: lead

Study Sites (1)

Seoul National University Hospial

Seoul, Jongro-go, 03080, South Korea

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Central Study Contacts

BeyondBio Inc.

CONTACT

+82-42-716-0020; clinicaltrials@beyondbio.co.kr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2021
• First Posted: October 26, 2021
• Study Start: August 31, 2021
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 10, 2025

Record last verified: 2025-03

Locations

KR (1)