Status:
TERMINATED
Phase 1/2 Study of BBT-176 in Advanced NSCLC With Progression After EGFR TKI Treatment
Lead Sponsor:
Bridge Biotherapeutics, Inc.
Conditions:
NSCLC
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This clinical trial is the first-in-human study of BBT-176. The purpose of this trial is to investigate the safety and tolerability of BBT-176 (Part 1) and to evaluate the anti-tumor activity of BBT-1...
Eligibility Criteria
Inclusion
- Key
- Provision of signed and dated, written informed consent before any study specific procedures, sampling and analyses
- Histological or cytological confirmation of advanced and/or metastatic stage IIIB/IV NSCLC
- Radiological documentation of disease progression while on a previous continuous (at least 30 days) treatment with an EGFR TKI monotherapy (including, but not limited to, osimertinib, afatinib, gefitinib, or erlotinib)
- Patients must fulfill one of the following:
- Confirmation that the tumor harbors an EGFR mutation known to be associated with EGFR TKI sensitivity (including, but not limited to, exon 19 deletion, L858R, or L861Q)
- Documented partial or complete response or a significant and durable stable disease (at least 6 months), based on the RECIST or WHO criteria, after treatment of an EGFR TKI
- Key
Exclusion
- Treatment with any of the following:
- An EGFR TKI, including but not limited to osimertinib, afatinib, gefitinib, or erlotinib within 8 days of the first dose of study treatment.
- Any cytotoxic chemotherapy, investigational agents, or anticancer drugs for the treatment of advanced NSCLC, between prior EGFR TKI treatment and BBT-176 treatment
- Major surgery (excluding placement of vascular access) within 4 weeks of the first dose of study treatment
- Radiotherapy with a limited field of radiation for palliation within 1 week of the first dose of study treatment
- Patients receiving radiation to more than 30% of the bone marrow or with a wide field of radiation within 6 weeks of the first dose of study treatment
- Any unresolved toxicities from prior therapy greater than NCI Common Terminology Criteria for Adverse Events (CTCAE v5.0) Grade 1 at the time of starting study treatment, with the exception of alopecia and Grade 2 neuropathy related to prior platinum-therapy
- Spinal cord compression or brain metastases, unless asymptomatic and stable
Key Trial Info
Start Date :
April 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 29 2023
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT04820023
Start Date
April 2 2021
End Date
November 29 2023
Last Update
June 6 2025
Active Locations (4)
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1
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea, 13605
2
Samsung Medical Center
Seoul, South Korea
3
Seoul National University Hospital
Seoul, South Korea
4
Severance Hospital
Seoul, South Korea