Antitumor Activity and Safety of BEBT-109, a Novel EGFR Inhibitor, in Previously Treated NSCLC
NCT06001671 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 23
Last updated 2023-10-06
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 in patients with locally advanced or metastatic NSCLC harboring EGFR exon20ins mutations who had received at least one line of previous treatment.
Conditions
Interventions
- DRUG
-
BEBT-109
BEBT-109 is based on the "3+3" model, with a dose ascent starting from 120mg qd
Sponsors & Collaborators
-
Hunan Province Tumor Hospital
lead OTHER
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-10-27
- Primary Completion
- 2023-03-01
- Completion
- 2023-08-08
Countries
- China
Study Locations
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