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NSCLCPhase 1/2NCT04820023

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

A Phase 1/2 study testing BBT-176, QD and BBT-176, BID in people with NSCLC, run by Bridge Biotherapeutics, Inc. at 4 sites in South Korea.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
NSCLC
What is being tested?
BBT-176, QD and BBT-176, BID
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
4 sitesSouth Korea
Study dates
2 Apr 2021to 29 Nov 2023
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • 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

Who cannot join

  • 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

Trial locations and contacts

4 sites in 1 country.

South Korea4 sites

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13605

  • Samsung Medical Center

    Seoul

  • Seoul National University Hospital

    Seoul

  • Severance Hospital

    Seoul

Other trials in South Korea

About this study

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

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).

Conditions
NSCLC
Being tested
BBT-176, QD, BBT-176, BID

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BBT-176, QDDrug

    BBT-176 given orally alone, QD

  • BBT-176, BIDDrug

    BBT-176 given orally alone, BID

Study groups in NCT04820023
Study groupRoleWhat they receive
20mg QDExperimentalBBT-176: 20mg, Orally, Once daily (QD)
Receives: Drug: BBT-176, QD
80mg QDExperimentalBBT-176: 80mg, Orally, QD
Receives: Drug: BBT-176, QD
160mg QDExperimentalBBT-176: 160mg, Orally, QD
Receives: Drug: BBT-176, QD
320mg QDExperimentalBBT-176: 320mg, Orally, QD
Receives: Drug: BBT-176, QD
480mg QDExperimentalBBT-176: 480mg, Orally, QD
Receives: Drug: BBT-176, QD
600mg QDExperimentalBBT-176: 600mg, Orally, QD
Receives: Drug: BBT-176, QD
160mg, BIDExperimentalBBT-176: 160mg, Orally, Twice daily (BID)
Receives: Drug: BBT-176, BID
200mg, BIDExperimentalBBT-176: 200mg, Orally, BID
Receives: Drug: BBT-176, BID
240mg, BIDExperimentalBBT-176: 240mg, Orally, BID
Receives: Drug: BBT-176, BID

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. (Part 1) Incidence of Adverse Events and Clinical Laboratory Abnormalities Defined as Dose-limiting Toxicities (DLTs)

    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.

    Measured: 21 days from the first dosing

  2. (Part 2) Objective Response Rate (ORR)

    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.

    Measured: Every 6 weeks

Secondary outcomes (7)

  1. (Part 1) Objective Response Rate (ORR)

    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.

    Measured: Every 6 weeks, approximately 1 year

  2. (Part 1) Pharmacokinetics (PK) Parameters - Peak Concentration (Cmax)

    Peak plasma concentration (Cmax) of BBT-176 from Part 1.

    Measured: 0, 1, 2, 4, 6, 8, 12 hours post-dose on Cycle 1 Day 1 (C1D1) and Cycle 2 Day 1 (C2D1) (each cycle is 21 days)

  3. (Part 1) PK Parameters - Area Under the Concentration-time Curve (AUC)

    Area under the plasma concentration-time curve (AUC) of BBT-176 from Part 1.

    Measured: 0, 1, 2, 4, 6, 8, 12 hours post-dose on Cycle 1 Day 1 (C1D1) and Cycle 2 Day 1 (C2D1) (each cycle is 21 days)

  4. (Part 2) Duration of Response (DoR)

    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.

    Measured: throughout study completion, approximately 1 year

  5. (Part 2) Incidence of Adverse Event (AE)s

    Number of patients experiencing adverse event (AE)s

    Measured: throughout study completion, approximately 1 year

  6. (Part 2) BBT-176 Concentrations

    Plasma BBT-176 concentrations at steady state

    Measured: At Cycle 2 Day 1 (each cycle is 21 days)

  7. (Part 2) Progression Free Survival (PFS)

    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.

    Measured: throughout study completion, approximately 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2021
  2. Study start2 Apr 2021
  3. Primary completion29 Nov 2023
  4. Study completion29 Nov 2023

Why it stopped: Sponsor's decision considering the changing treatment landscape for NSCLC

Resources

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04820023
Sponsor's protocol ID
BBT176-ONC-001
Status last verified
Jun 2025
First submitted
23 Mar 2021
Last updated
6 Jun 2025
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Lim SM, Fujino T, Kim C, Lee G, Lee YH, Kim DW, Ahn JS, Mitsudomi T, Jin T, Lee SY. BBT-176, a Novel Fourth-Generation Tyrosine Kinase Inhibitor for Osimertinib-Resistant EGFR Mutations in Non-Small Cell Lung Cancer. Clin Cancer Res. 2023 Aug 15;29(16):3004-3016. doi: 10.1158/1078-0432.CCR-22-3901.

    PubMed 37249619

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing BBT-176, QD and BBT-176, BID in people with NSCLC, run by Bridge Biotherapeutics, Inc. at 4 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 6 inclusion and 8 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: stopped early, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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?

Yes. Results are posted in the registry (first posted 6 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

(Part 1) Incidence of Adverse Events and Clinical Laboratory Abnormalities Defined as Dose-limiting Toxicities (DLTs) (time frame: 21 days from the first dosing). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04820023, which also lists 1 linked publication.

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 6 Jun 2025.

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