EGFR Mutant Advanced Non-Small Cell Lung CancerPhase 1/2NCT05920135
First-in-Human Study of BBT-207 in Advanced Non-Small Cell Lung Cancer Harboring EGFR Mutation After Treatment With EGFR TKI
A Phase 1/2 study testing BBT-207 in people with EGFR Mutant Advanced Non-Small Cell Lung Cancer, run by Bridge Biotherapeutics, Inc. at 3 sites in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- EGFR Mutant Advanced Non-Small Cell Lung Cancer
- What is being tested?
- BBT-207
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 11 Sep 2023to 1 Aug 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed Stage III (locally advanced) NSCLC not amenable to curative therapy or stage IV NSCLC.
- Patients must have received treatment with at least 1 third-generation EGFR TKI (eg, Osimertinib, Lazertinib).
- Confirmation that the tumor harbors an EGFR mutation as follows:
- 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).
- Phase 1b (RP2D Selection): Have complex EGFR mutations containing C797S confirmed.
- Phase 2 (Dose Expansion): Have complex EGFR mutations containing C797S confirmed by a central laboratory.
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- 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.
- 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).
- All patients must have documented radiological progression or intolerance to the last treatment administered prior to enrolling in the study.
- Has Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Adequate organ function test result.
- 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).
Who cannot join
- Has symptomatic brain or spinal cord metastases with exceptions.
- Any of the following cardiac conditions within the last 6 months from the first dose of study treatment:
- Unexplained or cardiovascular cause of presyncope or syncope, tachycardia, ventricular fibrillation, or sudden cardiac arrest.
- Prolonged corrected QT interval (mean resting corrected QT interval using Fridericia's formula [QTcF] >470 msec from 3 ECGs).
- 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>
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- An EGFR TKI, including but not limited to osimertinib, afatinib, dacomitinib, gefitinib, or erlotinib within 8 days of the first dose of study treatment.
- 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.
- 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.
- 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.
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Seoul National University Hospital
Seoul, 03080
Samsung Medical Center
Seoul, 06351
About this study
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.
- Being tested
- BBT-207
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BBT-207Drug
BBT-207 given orally alone
| Study group | Role | What they receive |
|---|---|---|
| Phase 1a; Dose escalation at various dose levels in patients with EGFR TKI sensitizing mutation | Experimental | Not described Receives: Drug: BBT-207 |
| Phase 1b; At 2 recommended dose levels of BBT-207 in patients with EGFR C797S mutation | Experimental | Not described Receives: Drug: BBT-207 |
| Phase 2; At the recommended phase 2 dose of BBT-207 in patients with EGFR C797S mutation | Experimental | Not described Receives: Drug: BBT-207 |
What is being measured
The primary outcome is the main question the study is designed to answer.
[Phase 1a dose escalation] Determine Recommended Dose Range
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
Measured: 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.
Type, frequency, and severity of TEAEs according to NCI Common Terminology Criteria for Adverse Events Version 5.0 criteria.
Measured: Throughout study completion, approximately 12 months
[Phase 1b Recommended Phase 2 Dose selection] Determine the RP2D
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.
Measured: Approximately 12 months
[Phase 2 dose expansion] Evaluate preliminary antitumor activity
ORR defined as the percentage of patients with PR or CR based on RECIST Version 1.1.
Measured: Approximately 12 months
Secondary outcomes (18)
[Phase 1a, Phase 1b, Phase 2] observed maximum plasma concentration after administration [Cmax]
Measured: 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]
Measured: 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]
Measured: 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]
Measured: 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-∞]
Measured: Up to Cycle 2 Day 2 (each cycle is 21 days)
[Phase 1a, Phase 1b, Phase 2] terminal elimination half-life [t½]
Measured: Up to Cycle 2 Day 2 (each cycle is 21 days)
[Phase 1a, Phase 1b, Phase 2] terminal elimination rate constant [λz]
Measured: Up to Cycle 2 Day 2 (each cycle is 21 days)
[Phase 1a, Phase 1b, Phase 2] apparent clearance following extravascular administration [CL/F]
Measured: 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]
Measured: 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]
Measured: 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]
Measured: 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
Measured: 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)
Measured: Approximately 12 months
[Phase 1a, Phase 1b, Phase 2] Time to Response [TTR] per RECIST Version 1.1
Measured: 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
Measured: 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
Measured: 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
Measured: Approximately 3 years
[Phase1b, Phase2] Incidence of Treatment-Emergent Adverse Events, Adverse Events of Special Interest, Serious Adverse Events, and ≥grade 3 laboratory abnormalities.
Type, frequency, and severity of TEAEs according to NCI Common Terminology Criteria for Adverse Events Version 5.0 criteria.
Measured: Throughout study completion, approximately 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start11 Sep 2023
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EGFR Mutant Advanced Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bridge Biotherapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05920135
- Sponsor's protocol ID
- BBT207-ONC-001
- Status last verified
- Nov 2024
- First submitted
- 26 May 2023
- Last updated
- 27 Apr 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-in-Human Study of BBT-207 in Advanced Non-Small Cell Lung Cancer Harboring EGFR Mutation After Treatment With EGFR TKI
- ClinicalTrials.gov ID
- NCT05920135
- Acronym / sponsor ID
- BBT207-ONC-001
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Bridge Biotherapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Sep 2023 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 27 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase 1a; Dose escalation at various dose levels in patients with EGFR TKI sensitizing mutation | Experimental | Drug: BBT-207 |
| Phase 1b; At 2 recommended dose levels of BBT-207 in patients with EGFR C797S mutation | Experimental | Drug: BBT-207 |
| Phase 2; At the recommended phase 2 dose of BBT-207 in patients with EGFR C797S mutation | Experimental | Drug: BBT-207 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histologically or cytologically confirmed Stage III (locally advanced) NSCLC not amenable to curative therapy or stage IV NSCLC.
- Patients must have received treatment with at least 1 third-generation EGFR TKI (eg, Osimertinib, Lazertinib).
- Confirmation that the tumor harbors an EGFR mutation as follows:
- 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.
- 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).
Key exclusion criteria (10 listed)
- Has symptomatic brain or spinal cord metastases with exceptions.
- Any of the following cardiac conditions within the last 6 months from the first dose of study treatment:
- <Prior or Concomitant Anticancer Therapy>
- An EGFR TKI, including but not limited to osimertinib, afatinib, dacomitinib, gefitinib, or erlotinib within 8 days of the first dose of study treatment.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BBT-207BBT-207 given orally alone | Drug | Phase 1a; Dose escalation at various dose levels in patients with EGFR TKI sensitizing mutation, Phase 1b; At 2 recommended dose levels of BBT-207 in patients with EGFR C797S mutation, Phase 2; At the recommended phase 2 dose of BBT-207 in patients with EGFR C797S mutation |
Primary outcome
[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
[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.
[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.
[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.
18 secondary outcomes
[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)
[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)
[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)
[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)
[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)
[Phase 1a, Phase 1b, Phase 2] terminal elimination half-life [t½]
Time frame: 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)
[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)
[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)
[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)
[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)
[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
[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
[Phase 1a, Phase 1b, Phase 2] Time to Response [TTR] per RECIST Version 1.1
Time frame: 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
[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
[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
[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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BBT-207 in people with EGFR Mutant Advanced Non-Small Cell Lung Cancer, run by Bridge Biotherapeutics, Inc. at 3 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
[Phase 1a dose escalation] Determine Recommended Dose Range (time frame: Approximately 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.