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

Metastatic Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05093907
• Other study ID #: BEY-2021-01
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: August 31, 2021
• Est. completion date: July 31, 2024

Study information

• Verified date: September 2021
• Source: BeyondBio Inc.
• Contact: BeyondBio Inc.
• Phone: +82-42-716-0020
• Email: clinicaltrials[@]beyondbio.co.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 27
• Est. completion date: July 31, 2024
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospial	Seoul	Jongro-go

Sponsors (1)

Lead Sponsor	Collaborator
BeyondBio Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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	From baseline up to 24 hour post-dose
Secondary	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	From baseline up to 24 hour post-dose
Secondary	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	From baseline up to 24 hour post-dose
Secondary	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	From baseline up to disease progression, approximately 24 months
Secondary	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)	From baseline up to approximately 24 months