Overview
First-in-Human Study of BBT-207 in Advanced Non-Small Cell Lung Cancer Harboring EGFR Mutation After Treatment With EGFR TKI
Status:
Recruiting
Recruiting
Trial end date:
2028-08-01
2028-08-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 1/Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Bridge Biotherapeutics, Inc.
Criteria
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).
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.