Study of BEBT-109 in Subjects With EGFR Exon 20 Insertion Mutations Non-Small Cell Lung Cancer

NCT06706713 | Recruiting Phase 2 DMC

• 1 other identifier: GBMT-109-P02
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

This study is an open-label, multicenter Phase II trial, planning to enroll 200 subjects, using BEBT-109 capsules as monotherapy, aimed at evaluating the efficacy and safety of BEBT-109 capsules in subjects with Epidermal Growth Factor Receptor (EGFR) exon 20 insertion mutations in locally advanced or metastatic Non-Small Cell Lung Cancer （NSCLC）.

Conditions

Non-Small Cell Lung Cancer; EGFR Exon 20 Insertion Mutation

Keywords

BEBT-109; EGFR Exon 20 Insertion Mutations; Efficacy; Safety

Outcome Measures

Primary Outcomes (2)

• ORR

  Objective Response Rate

  Every 8 weeks,assessed up to 24 months.

• PFS

  Progression-Free Survival

  Every 8 weeks,assessed up to 24 months.

Secondary Outcomes (5)

• DOR

  Every 8 weeks,assessed up to 24 months.

• DCR

  Every 8 weeks,assessed up to 24 months.

• TTR

  Every 8 weeks,assessed up to 24 months.

• OS

  From date of administration until date of death from any cause, assessed up to 24 months.

• Adverse Events

  From the first dose of medication to 30 days after the last dose in subjects.

Study Arms (1)

BEBT-109 Capsule Treatment

EXPERIMENTAL

BEBT-109 Capsule: Administration and dosage: Oral administration, 120mg; Frequency and duration of administration: Twice a day,and 28 days as a treatment cycle.

Drug: BEBT-109 Capsule

Interventions

BEBT-109 Capsule DRUG

Take orally before breakfast and dinner each day, with a minimum interval of 9 hours between doses, 120mg each time, twice a day,and 28 days as a treatment cycle.

Also known as: KCBT-1083

BEBT-109 Capsule Treatment

Eligibility Criteria

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

You may qualify if:

• Subjects who have been fully informed and are willing to sign the informed consent form.
• Age of at least 18 years, with no gender restrictions.
• According to the 8th edition of the American Joint Committee on Cancer (AJCC) lung cancer Tumor Node Metastasis (TNM) staging criteria: histologically or cytologically confirmed locally advanced (stages IIIB or IIIC, and deemed unsuitable for surgery or radiotherapy by the investigator) or metastatic (stage IV) NSCLC.
• Written test reports confirm the occurrence of EGFR exon 20 insertion mutations.
• Cohort 1 includes NSCLC patients who have failed or are intolerant to at least one systemic chemotherapy (defined as having undergone at least one platinum-based chemotherapy regimen or other chemotherapy regimen) and have not received third-generation EGFR TKI treatment; Cohort 2 includes NSCLC patients who have failed or are intolerant to at least one systemic chemotherapy (defined as having undergone at least one platinum-based chemotherapy regimen or other chemotherapy regimen) and have experienced Progressive Disease after receiving standard doses of third-generation EGFR TKI (such as osimertinib 80 mg once daily, or savolitinib 80 mg once daily, or alectinib 110 mg once daily, etc.).
• Eastern Cooperative Oncology Group (ECOG) score of 0-2, with no decline in physical performance in the past two weeks, and an expected survival of at least 12 weeks.
• Subjects must have at least one measurable lesion according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 criteria.
• Laboratory tests indicate that subjects have adequate organ function: including: a. Absolute neutrophil count (ANC) ≥1.5×10\^9/L; platelet count (PLT) ≥100×10\^9/L; hemoglobin (HGB) ≥80g/L; b. Serum total bilirubin (TBIL) ≤1.5 times the upper limit of normal (ULN), aspartate transaminase (AST) and alanine aminotransferase (ALT) ≤2.5 times ULN (for those with liver metastasis, total bilirubin ≤3 times ULN, AST and ALT ≤5 times ULN are allowed); c. Creatinine ≤1.5 times ULN, when creatinine \>1.5 times ULN, creatinine clearance must be confirmed, and creatinine clearance must be ≥45 ml/min (actual value, or calculated by the Cockcroft-Gault formula); d. Activated partial thromboplastin time (APTT) ≤1.5 times ULN, prothrombin time (PT) ≤1.5 times ULN, international normalized ratio (INR) ≤1.5 times ULN.
• If the subject is a female with childbearing potential, she must use adequate contraceptive measures (such as condoms), must not breastfeed, and must have a negative blood pregnancy test before dosing.
• male subjects must be willing to use barrier contraceptive measures during the study period, i.e., condoms.

You may not qualify if:

• Individuals who have had other malignant tumors within 5 years prior to enrollment, except for basal cell carcinoma of the skin that has been removed and cured, in situ bladder cancer, or in situ cervical cancer.
• Those who have previously received drugs for EGFR exon 20 insertion mutations, such as Poziotinib, Tarloxotinib, TAK788, JNJ-61186372, CLN-081, or high-dose third-generation EGFR TKIs (Osimertinib \> 80 mg/day, Furmonertinib \> 80 mg/day, or Almonertinib \> 110 mg/day, etc.).
• Any other anti-cancer treatment within 4 weeks prior to the first use of the study drug (including cytotoxic chemotherapy, radiotherapy, immunotherapy, or other biological therapies; for Mitomycin or Nitrosoureas, within 6 weeks; for small molecule targeted drugs, at least 2 weeks or at least 5 half-lives from the last dose, whichever is longer).
• Received medication from another clinical trial within 4 weeks prior to the first administration of the study treatment.
• Undergone major surgery (excluding vascular access procedures) within 4 weeks prior to the first administration of the study treatment.
• Currently using or having used within 1 week known strong inhibitors or inducers of CYP3A4 and CYP2C8, including medications or herbal supplements.
• At the start of the study treatment, unresolved toxicities from previous treatments that are more than Grade 1 according to the Common Terminology Criteria for Adverse Events (CTCAE), except for alopecia, and neurotoxicity related to previous platinum treatment can be relaxed to Grade 2.
• Spinal cord compression, meningeal metastasis, or brain metastasis, except for those who are asymptomatic, stable, and have not required steroid medication within 4 weeks prior to the start of the study treatment.
• Patients with symptomatic and unstable pleural effusion or ascites.
• Those with severe or uncontrolled systemic diseases requiring treatment, deemed unsuitable for the trial by the investigator, including hypertension, diabetes, chronic heart failure (New York Heart Association (NYHA) class III-IV), unstable angina, myocardial infarction within 1 year, active bleeding, etc..
• Individuals with uncontrolled active infections.
• Clinically significant active infections, including Hepatitis B (HBV) and Hepatitis C (HCV). Active Hepatitis B is defined as Hepatitis B surface antigen (HBsAg) positive with detectable HBV DNA copies above the upper limit of normal of the testing laboratory. Patients with HBV DNA copies above the normal limit are allowed to receive antiviral treatment before screening to reduce the viral load to below the normal limit, but must continue antiviral treatment for Hepatitis B during the trial; Active Hepatitis C is defined as HCV RNA above the detection limit.
• History of immunodeficiency, including positive Human Immunodeficiency Virus (HIV) antibody tests, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.
• At rest, the average corrected QT interval (QTc) from three Electrocardiogram (ECG) examinations is \>450 msec (only if the first ECG suggests QTc \>450 msec, two more measurements are required, and the average of the three values is taken).
• Various severe and clinically significant cardiac rhythm, conduction, and resting ECG morphological abnormalities, such as complete left bundle branch block, third-degree block, second-degree block, PR interval \>250 msec, etc..

Sponsors & Collaborators

• BeBetter Med Inc: lead

Study Sites (2)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Nong Yang, Phd

  Hunan Cancer Hospital

  PRINCIPAL INVESTIGATOR

• Yilong Wu, Phd

  Guangdong Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kegang Jiang, Master

CONTACT

+86-18664786382; kjiang@bebettermed.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study is designed with two cohorts, each comprising approximately 100 subjects. Subjects receive BEBT-109 capsules treatment with a dosage of 120mg bid (twice a day), and each 28-day period constitutes a cycle. In case of intolerance during the treatment, dose adjustments can be made according to the adjustment plan.

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: November 26, 2024
• Study Start: April 15, 2022
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: November 26, 2024

Record last verified: 2024-11

Locations

CN (2)