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Phase 1/2 Study of BBT-176 in Advanced NSCLC With Progression After EGFR TKI Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04820023
Recruitment Status : Recruiting
First Posted : March 29, 2021
Last Update Posted : January 9, 2023
Sponsor:
Information provided by (Responsible Party):
Bridge Biotherapeutics, Inc.

Study Description
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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-176 (Part 2).

Condition or disease Intervention/treatment Phase
NSCLC Drug: BBT-176 Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 168 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 2, 2021
Estimated Primary Completion Date : December 30, 2023
Estimated Study Completion Date : June 30, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: BBT-176 Drug: BBT-176
BBT-176 given orally alone


Outcome Measures
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Primary Outcome Measures :
  1. (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.

  2. (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.


Secondary Outcome Measures :
  1. (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

  2. (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

  3. (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.

  4. (Part 2) Duration of Response (DoR) [ Time Frame: throughout study completion, approximately 1 year ]
    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.

  5. (Part 2) Incidence of Adverse Event (AE)s [ Time Frame: throughout study completion, approximately 1 year ]
    Number of patients experiencing AEs

  6. (Part 2) BBT-176 concentrations [ Time Frame: At Cycle 2 Day 1 (each cycle is 21 days) ]
    Plasma BBT-176 concentrations at steady state

  7. (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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04820023


Contacts
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Contact: Bridge Biotherapeutics, Inc. +82-31-8092-3280 clinicaltrials.gov_inquiries@Bridgebiorx.com

Locations
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Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 13605
Contact: Hyunah Choi    +82-31-787-8352    kkjchk@naver.com   
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Sungsuk Lee    82-2-3410-6764    sungsuk.lee@samsung.com   
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: SeungJin Yu    82-2-2072-7617    promotion0502@gmail.com   
Severance Hospital Recruiting
Seoul, Korea, Republic of
Contact: Soo Min Kim    82-2-2228-0448    su-minnn@yuhs.ac   
Sponsors and Collaborators
Bridge Biotherapeutics, Inc.
More Information
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Responsible Party: Bridge Biotherapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04820023    
Other Study ID Numbers: BBT176-ONC-001
First Posted: March 29, 2021    Key Record Dates
Last Update Posted: January 9, 2023
Last Verified: January 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
 Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases