Clinical trial NCT04820023: Phase 1/2 Study of BBT-176 in Advanced NSCLC With Progression After EGFR TKI Treatment
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: NSCLC
Lead sponsor: Bridge Biotherapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2021-03-29
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: Key Inclusion Criteria:

* 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

Key Exclusion Criteria:

* 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

Primary outcomes:
measure: (Part 1) Incidence of Adverse Events and Clinical Laboratory Abnormalities Defined as Dose-limiting Toxicities (DLTs)
timeFrame: 21 days from the first dosing
measure: (Part 2) Objective Response Rate (ORR)
timeFrame: Every 6 weeks
Secondary outcomes:
measure: (Part 1) Objective Response Rate (ORR)
timeFrame: Every 6 weeks, approximately 1 year
measure: (Part 1) Pharmacokinetics (PK) Parameters - Peak Concentration (Cmax)
timeFrame: 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)
measure: (Part 1) PK Parameters - Area Under the Concentration-time Curve (AUC)
timeFrame: 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)
measure: (Part 2) Duration of Response (DoR)
timeFrame: throughout study completion, approximately 1 year
measure: (Part 2) Incidence of Adverse Event (AE)s
timeFrame: throughout study completion, approximately 1 year
measure: (Part 2) BBT-176 Concentrations
timeFrame: At Cycle 2 Day 1 (each cycle is 21 days)
measure: (Part 2) Progression Free Survival (PFS)
timeFrame: throughout study completion, approximately 1 year
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References: