Status:
COMPLETED
Antitumor Activity and Safety of BEBT-109, a Novel EGFR Inhibitor, in Previously Treated NSCLC
Lead Sponsor:
Hunan Province Tumor Hospital
Conditions:
NSCLC
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This clinical study was a first-in-human, phase 1B, single-center, single-arm, open-label, dose escalation and expansion trial that aimed to determine the safety, tolerability and efficacy of BEBT-109...
Eligibility Criteria
Inclusion
- Sign written informed consent before implementing any trial-related procedures;
- Age ≥18 years and no limit on the gender.
- Histologically or cytologically confirmed locally advanced or metastatic NSCLC with EGFR exon20ins mutation according to assessments made in local laboratories.
- Previous treatment and type of mutation:
- Disease progression in doses extension cases may have been treated with an EGFR-TKI (e.g., gefitinib, erlotinib, eclitinib, afatinib, or dapatinib) and prior written test reports confirming EGFR T790M mutation.
- Disease progression after prior chemotherapy regimen and/or EGFR-TKI treatment in dose-extension cases, and prior written test reports confirming EGFR 20 exon insertion mutations.
- Disease progression following prior chemotherapy regimen and/or EGFR-TKI treatment in dose-extension cases, and prior written test reports confirming other rare mutations in EGFR (EGFR G719A, L861Q, or S768I point mutations).
- Patients who are intolerant to chemotherapy or EGFR-TKI and have no other effective treatment can also be admitted to the dose expansion group after judgment by the investigator.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Patients with brain metastasis were only enrolled if the metastases were stable.
- Subjects had at least 1 measurable lesion that met the RECIST 1.1 criteria.
- If female subjects are of childbearing potential, adequate contraception (e.g., condoms, etc.) should be used, no breastfeeding should be used, and a negative pregnancy test before administration should be given.
Exclusion
- Combined with any other malignancy (except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix).
- Genetic testing confirmed the presence of C-MET amplification, HER-2 amplification and KRAS mutations, and other genetic mutations that clearly confirm resistance to EGFR-TKI.
- From the last treatment of EGFR-TKI (such as erlotinib, gefitinib, eclitinib, afatinib or osimertinib, etc.) to the first administration of this clinical trial, the interval is less than 14 days or 5 half-lives (whichever is longer is the exclusion criterion), and the specific drugs involved are decided by the investigator based on comprehensive consideration.
- In the 4 weeks prior to the first administration of the study treatment, participants had used other anticancer drugs (including immune cell therapy) in the previous treatment regimen.
- Those who have not withdrawn from other clinical trials within 4 weeks prior to the first administration of the study treatment.
- Previous homogeneous drug restriction:
- Patients with EGFR mutation previously treated with osimertinib or other third-generation EGFR inhibitor drugs (eg, ivelitinib, emetinib, and eflotinib) ;
- EGFR exon20 insertion mutants have used drugs that target EGFR 20 exon insertion mutants (e.g. Poziotinib tarloxotinib TAK788 JNJ-61186372 CLN-081, etc.)
- Other EGFR rare mutations (EGFR G719A, L861Q, or S768I point mutations) have been treated with afatinib.
Key Trial Info
Start Date :
October 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 8 2023
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT06001671
Start Date
October 27 2020
End Date
August 8 2023
Last Update
October 6 2023
Active Locations (1)
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1
Hunan Cancer hospital
Changsha, Hunan, China