First-in-Human Study of BBT-207 in Advanced Non-Small Cell Lung Cancer Harboring EGFR Mutation After Treatment With EGFR TKI

April 24, 2025 updated by: Bridge Biotherapeutics, Inc.
This is an open label, multi-center, Phase 1/2 study evaluating the safety, tolerability, PK, PD, and preliminary efficacy (antitumor activity) of BBT-207. It will consist of 3 parts; dose escalation, recommended phase 2 dose selection, and dose expansion.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
        • Seoul National University Bundang Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Histologically or cytologically confirmed Stage III (locally advanced) NSCLC not amenable to curative therapy or stage IV NSCLC.
  2. Patients must have received treatment with at least 1 third-generation EGFR TKI (eg, Osimertinib, Lazertinib).

  3. Confirmation that the tumor harbors an EGFR mutation as follows:

    1. Phase 1a (Dose Escalation): Confirmation that the tumor harbors an EGFR mutation known to be associated with EGFR TKI sensitivity (exon 19 deletion or L858R).
    2. Phase 1b (RP2D Selection): Have complex EGFR mutations containing C797S confirmed.
    3. Phase 2 (Dose Expansion): Have complex EGFR mutations containing C797S confirmed by a central laboratory.
  4. Documented partial or complete response (CR) or durable (at least 16 weeks) stable disease, based on the RECIST criteria, after treatment of an EGFR TKI.
  5. Radiological documentation of disease progression or intolerance to a previous continuous (at least 30 days) treatment with an approved EGFR TKI therapy (including, but not limited to osimertinib, afatinib, dacomitinib, gefitinib, or erlotinib).
  6. All patients must have documented radiological progression or intolerance to the last treatment administered prior to enrolling in the study.
  7. Has Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
  8. Adequate organ function test result.
  9. All standard therapeutic options have been exhausted, refused by the patient, or are contraindicated; or the patient is deemed by the investigator not to be an appropriate candidate for standard-of-care treatment (as defined in the country of participation).

Exclusion Criteria:

  1. Has symptomatic brain or spinal cord metastases with exceptions.

  2. Any of the following cardiac conditions within the last 6 months from the first dose of study treatment:

    1. Unexplained or cardiovascular cause of presyncope or syncope, tachycardia, ventricular fibrillation, or sudden cardiac arrest.
    2. Prolonged corrected QT interval (mean resting corrected QT interval using Fridericia's formula [QTcF] >470 msec from 3 ECGs).
    3. Clinically significant, uncontrolled, cardiovascular disease including congestive heart failure grade 3 or 4 according to the New York Heart Association classification; myocardial infarction or unstable angina, uncontrolled hypertension, or clinically significant, uncontrolled arrhythmias, including bradyarrhythmia that may cause QT prolongation (eg, Type II second degree heart block or third-degree heart block).

    <Prior or Concomitant Anticancer Therapy>

  3. An EGFR TKI, including but not limited to osimertinib, afatinib, dacomitinib, gefitinib, or erlotinib within 8 days of the first dose of study treatment.
  4. Small molecule targeted inhibitor other than EGFR inhibitor class or cytotoxic chemotherapy within 14 days, or biologic anticancer medicine (cytokines or antibodies, etc.) within 28 days (before the initiation of BBT-207 treatment) for the systemic treatment of advanced NSCLC.
  5. Has toxicities from previous anticancer therapies that have not resolved to baseline levels or to CTCAE grade ≤1, with the exception of alopecia and peripheral neuropathy.
  6. Has had radiotherapy within 14 days before the initiation of study treatment. Note: Palliative radiotherapy for pain can be administered at any time before the first dose of study treatment.

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: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Phase 1a; Dose escalation at various dose levels in patients with EGFR TKI sensitizing mutation
Drug: BBT-207
BBT-207 given orally alone
Experimental: Phase 1b; At 2 recommended dose levels of BBT-207 in patients with EGFR C797S mutation
Drug: BBT-207
BBT-207 given orally alone
Experimental: Phase 2; At the recommended phase 2 dose of BBT-207 in patients with EGFR C797S mutation
Drug: BBT-207
BBT-207 given orally alone

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
[Phase 1a dose escalation] Determine Recommended Dose Range
Time Frame: Approximately 12 months
RDR determination: between the minimal reproducibly active dose and the maximum tolerated dose or maximum administered dose. Based on the totality of the data including toxicity/tolerability, efficacy, PK, and PD
Approximately 12 months
[Phase 1a dose escalation] Incidence of Treatment-Emergent Adverse Events, Adverse Events of Special Interest, Serious Adverse Events, and ≥grade 3 laboratory abnormalities.
Time Frame: Throughout study completion, approximately 12 months
Type, frequency, and severity of TEAEs according to NCI Common Terminology Criteria for Adverse Events Version 5.0 criteria.
Throughout study completion, approximately 12 months
[Phase 1b Recommended Phase 2 Dose selection] Determine the RP2D
Time Frame: Approximately 12 months
RP2D determination: The Safety Monitoring Committee will determine the RP2D based on the totality of the data including overall safety, pharmacokinetic, pharmacodynamic, and preliminary antitumor activity including the percentage of patients with PR or CR based on RECIST Version 1.1.and duration of response.
Approximately 12 months
[Phase 2 dose expansion] Evaluate preliminary antitumor activity
Time Frame: Approximately 12 months
ORR defined as the percentage of patients with PR or CR based on RECIST Version 1.1.
Approximately 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
[Phase 1a, Phase 1b, Phase 2] observed maximum plasma concentration after administration [Cmax]
Time Frame: Up to Cycle 2 Day 2 (each cycle is 21 days)
Up to Cycle 2 Day 2 (each cycle is 21 days)
[Phase 1a, Phase 1b, Phase 2] time to reach the observed maximum (peak) concentration [Tmax]
Time Frame: Up to Cycle 2 Day 2 (each cycle is 21 days)
Up to Cycle 2 Day 2 (each cycle is 21 days)
[Phase 1a, Phase 1b, Phase 2] area under the plasma concentration-time curve from time zero to dosing interval [AUC0-τ]
Time Frame: Up to Cycle 2 Day 2 (each cycle is 21 days)
Up to Cycle 2 Day 2 (each cycle is 21 days)
[Phase 1a, Phase 1b, Phase 2] Area under the concentration-time curve from time zero to the time with last measurable concentration [AUC0-t]
Time Frame: Up to Cycle 2 Day 2 (each cycle is 21 days)
Up to Cycle 2 Day 2 (each cycle is 21 days)
[Phase 1a, Phase 1b, Phase 2] area under the concentration-time curve from time zero extrapolated to infinity [AUC0-∞]
Time Frame: Up to Cycle 2 Day 2 (each cycle is 21 days)
Up to Cycle 2 Day 2 (each cycle is 21 days)
[Phase 1a, Phase 1b, Phase 2] terminal elimination half-life [t½]
Time Frame: Up to Cycle 2 Day 2 (each cycle is 21 days)
Up to Cycle 2 Day 2 (each cycle is 21 days)
[Phase 1a, Phase 1b, Phase 2] terminal elimination rate constant [λz]
Time Frame: Up to Cycle 2 Day 2 (each cycle is 21 days)
Up to Cycle 2 Day 2 (each cycle is 21 days)
[Phase 1a, Phase 1b, Phase 2] apparent clearance following extravascular administration [CL/F]
Time Frame: Up to Cycle 2 Day 2 (each cycle is 21 days)
Up to Cycle 2 Day 2 (each cycle is 21 days)
[Phase 1a, Phase 1b, Phase 2] apparent volume of distribution following extravascular administration [Vz/F]
Time Frame: Up to Cycle 2 Day 2 (each cycle is 21 days)
Up to Cycle 2 Day 2 (each cycle is 21 days)
[Phase 1a, Phase 1b, Phase 2] accumulation ratio [Rac] for Cmax and area under the plasma concentration-time curve [AUC]
Time Frame: Up to Cycle 2 Day 2 (each cycle is 21 days)
Up to Cycle 2 Day 2 (each cycle is 21 days)
[Phase 1a, Phase 1b, Phase 2] observed trough plasma concentration at the dosing interval [Ctrough]
Time Frame: Up to Cycle 2 Day 2 (each cycle is 21 days)
Up to Cycle 2 Day 2 (each cycle is 21 days)
[Phase 1a, Phase 1b] ORR defined as the percentage of patients with PR or CR based on RECIST Version 1.1
Time Frame: Approximately 12 months
Approximately 12 months
[Phase 1a, Phase 1b, Phase 2] DCR per RECIST Version 1.1, measured as percentage of patients with CR + PR + (SD ≥16 weeks)
Time Frame: Approximately 12 months
Approximately 12 months
[Phase 1a, Phase 1b, Phase 2] Time to Response [TTR] per RECIST Version 1.1
Time Frame: Approximately 12 months
Approximately 12 months
[Phase 1a, Phase 1b, Phase 2] Duration of Response [DOR] defined as the time from the first dose of BBT207 to disease progression or death in patients who achieve complete or partial response per RECIST Version 1.1
Time Frame: Approximately 12 months
Approximately 12 months
[Phase 1a, Phase 1b, Phase 2] Progression Free Survival [PFS] defined as the time from the first dose of BBT-207 until the date of first documented progressive disease or death due to any cause, whichever occurs first per RECIST Version 1.1
Time Frame: Approximately 12 months
Approximately 12 months
[Phase 2] Overall Survival [OS] defined as the time from the first dose of BBT-207 until the date of death due to any cause
Time Frame: Approximately 3 years
Approximately 3 years
[Phase1b, Phase2] Incidence of Treatment-Emergent Adverse Events, Adverse Events of Special Interest, Serious Adverse Events, and ≥grade 3 laboratory abnormalities.
Time Frame: Throughout study completion, approximately 12 months
Type, frequency, and severity of TEAEs according to NCI Common Terminology Criteria for Adverse Events Version 5.0 criteria.
Throughout study completion, approximately 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bridge Biotherapeutics, Inc.

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 11, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 26, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 27, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 27, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BBT207-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

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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