NCT04820023TerminatedPhase 1/2
Phase 1/2 Study of BBT-176 in Advanced NSCLC With Progression After EGFR TKI Treatment
A Phase 1/2, Open-Label Study to Assess the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of BBT-176 in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Who Progressed Following Prior Therapy With an Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR TKI) Agent
Source: ClinicalTrials.gov · Last updated 6 Jun 2025
Reason given: Sponsor's decision considering the changing treatment landscape for NSCLC
Brief summary (registry, in English)
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-176 (Part 2).
- Status (registry)
- Terminated
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 45 (actual)
- First submitted
- 23 Mar 2021
- Start date
- 2 Apr 2021
- Primary completion date
- 29 Nov 2023
- Lead sponsor
- Bridge Biotherapeutics, Inc.
- Diseases
- Lung cancer
- NCT number
- NCT04820023
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior 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
Lab values
- 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
Other
- Spinal cord compression or brain metastases, unless asymptomatic and stable
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam-si | South Korea | Unknown status |
| Severance hospital | Seoul | South Korea | Unknown status |
| Seoul National University Hospital | Seoul | South Korea | Unknown status |
| Samsung Medical Center | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.