RECRUITING

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

Conditions

EGFR Mutant Advanced Non-Small Cell Lung Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-09-11

Study Completion:2028-08-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05920135

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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).	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). 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.

Inclusion Criteria

Exclusion 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).

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).
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.

Contacts and Locations

Study Contact

Bridge Biotherapeutics, Inc.

CONTACT

+82-31-8092-3280

clinicaltrials.gov_inquiries@Bridgebiorx.com

Study Locations (Sites)

Mary Crowley Cancer Research

Dallas, Texas, 75251

United States

Collaborators and Investigators

Sponsor: 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 Registration Dates

Study Start Date2023-09-11

Study Completion Date2028-08-01

Study Record Updates

Study Start Date2023-09-11

Study Completion Date2028-08-01

Terms related to this study

Additional Relevant MeSH Terms

EGFR Mutant Advanced Non-Small Cell Lung Cancer