- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04820023
Phase 1/2 Study of BBT-176 in Advanced NSCLC With Progression After EGFR TKI Treatment
December 12, 2023 updated by: Bridge Biotherapeutics, Inc.
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
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).
Study Overview
Study Type
Interventional
Enrollment (Actual)
45
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Bridge Biotherapeutics, Inc.
- Phone Number: +82-31-8092-3280
- Email: clinicaltrials.gov_inquiries@Bridgebiorx.com
Study Locations
-
-
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Seoul, Korea, Republic of
- Seoul National University Hospital
-
Seoul, Korea, Republic of
- Samsung Medical Center
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Seoul, Korea, Republic of
- Severance Hospital
-
-
Gyeonggi-do
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Seongnam-si, Gyeonggi-do, Korea, Republic of, 13605
- Seoul National University Bundang Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Key Inclusion Criteria:
- 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 Criteria:
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BBT-176
|
BBT-176 given orally alone
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
(Part 1) Incidence of adverse events and clinical laboratory abnormalities defined as dose-limiting toxicities (DLTs)
Time Frame: 21 days from the first dosing
|
any toxicity not attributable to the disease or disease-related processes under investigation that occurs from the first dose of study treatment in dose-escalation cohorts as defined in the protocol.
|
21 days from the first dosing
|
(Part 2) Objective Response Rate (ORR)
Time Frame: Every 6 weeks
|
ORR is estimated by the number of patients with a best overall response of CR or PR divided by the total number of patients who are evaluable for efficacy.
|
Every 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
(Part 1) PK parameters - peak concentration (Cmax)
Time Frame: Up to Cycle 2 Day 1 (each cycle is 21 days)
|
Peak plasma concentration of BBT-176
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Up to Cycle 2 Day 1 (each cycle is 21 days)
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(Part 1) PK parameters - area under the concentration-time curve (AUC)
Time Frame: Up to Cycle 2 Day 1 (each cycle is 21 days)
|
Area under the plasma concentration-time curve of BBT-176
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Up to Cycle 2 Day 1 (each cycle is 21 days)
|
(Part 1) Objective Response Rate (ORR)
Time Frame: Every 6 weeks, approximately 1 year
|
ORR is estimated by the number of patients with a best overall response of Complete Response (CR) or Partial Response (PR) divided by the total number of patients who are evaluable for efficacy.
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Every 6 weeks, approximately 1 year
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(Part 2) Duration of Response (DoR)
Time Frame: throughout study completion, approximately 1 year
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DoR is calculated for every patient with a response to therapy (PR and CR) and is defined as the number of days from the date of initial response to the date of the first documented disease progression/relapse (including clinical progression) or death, whichever occurs first.
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throughout study completion, approximately 1 year
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(Part 2) Incidence of Adverse Event (AE)s
Time Frame: throughout study completion, approximately 1 year
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Number of patients experiencing AEs
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throughout study completion, approximately 1 year
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(Part 2) BBT-176 concentrations
Time Frame: At Cycle 2 Day 1 (each cycle is 21 days)
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Plasma BBT-176 concentrations at steady state
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At Cycle 2 Day 1 (each cycle is 21 days)
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(Part 2) Progression Free Survival (PFS)
Time Frame: throughout study completion, approximately 1 year
|
PFS will be calculated for each patient as the number of days from the first day of treatment to the date of the first documented disease progression or date of death, whichever occurs first.
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throughout study completion, approximately 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 2, 2021
Primary Completion (Actual)
November 29, 2023
Study Completion (Actual)
November 29, 2023
Study Registration Dates
First Submitted
March 23, 2021
First Submitted That Met QC Criteria
March 25, 2021
First Posted (Actual)
March 29, 2021
Study Record Updates
Last Update Posted (Actual)
December 14, 2023
Last Update Submitted That Met QC Criteria
December 12, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BBT176-ONC-001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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