Clinical trial NCT06032936: BBP-398 in Combination With Osimertinib in Locally Advanced or Metastatic NSCLC Patients With EGFR Mutations
Official title: An Open-label, Non-randomized, Multi-cohort, Multi-center Phase Ia/Ib Study Evaluating the Efficacy and Safety of BBP-398 in Combination With Osimertinib in Locally Advanced or Metastatic NSCLC Patients With EGFR Mutations
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: NSCLC
Lead sponsor: LianBio LLC
Sponsor class: INDUSTRY
First posted: 2023-09-13
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open-label, non-randomized, multi-cohort, multi-center Phase Ia/Ib study for BBP-398 in combination with Osimertinib to evaluate the safety, tolerability, pharmacokinetics, determine MTD and/or RP2D, and anti-cancer activity in locally advanced or metastatic NSCLC patients with EGFR mutations and with previously 3rd generation EGFR-TKIs treated or EGFR-TKI-naive.


Eligibility criteria: Inclusion Criteria:

* Patients must have the ability to understand and the willingness to sign a written informed consent document.
* Patients must be willing and able to comply with the scheduled visits, treatment plan, laboratory tests and other specified study procedures.
* Age ≥18, male or female.
* Patients are not suitable for surgical resection and must have histologically or cytologically confirmed advanced or metastatic NSCLC with documented EGFR sensitivity mutation (at any time since the initial diagnosis of NSCLC) to confirm susceptibility to EGFR-TKI therapy.
* Patients must have measurable disease by RECIST v1.1.
* ECOG performance status ≤2.
* Patients must have a life expectancy of ≥12 weeks as estimated at the time of screening.
* Patients must have adequate organ function.

Exclusion Criteria:

* Patients with a known additional malignancy that is progressing or requires active treatment.
* Patients who have previously received a SHP-2 inhibitor.
* Patients who are hypersensitivity to BBP-398/ Osimertinib or active or inactive excipients.
* Treatment with any of the following anti-cancer therapies prior to the first dose within the stated timeframes.
* Pregnant or breastfeeding female patients.
* Patients with untreated symptomatic brain metastases and/or meningeal metastases.

Primary outcomes:
measure: Treatment-emergent adverse events (TEAEs)
timeFrame: From the first study administration to approximately 28 days after the last study administration
measure: Serious adverse events (SAEs)
timeFrame: Administration to approximately 28 days after the last study administration
measure: Phase Ib: ORR assessed by the investigator according to RECIST v1.1
timeFrame: Every 8 weeks from first dose administration to the date of progression determined by the investigator or death due to any cause, whichever came first, assessed approximately 48 months.
Secondary outcomes:
measure: Phase Ia: QT Interval
timeFrame: Approximately 6 months
measure: Maximum plasma concentration (Cmax)
timeFrame: Approximately 6 months
measure: Area under the plasma concentration versus time curve (AUC)
timeFrame: Approximately 6 months
measure: Time to Reach Maximum Plasma Concentration (Tmax)
timeFrame: Approximately 6 months
measure: Apparent total plasma clearance (CL/F)
timeFrame: Approximately 6 months
measure: Terminal elimination half-life (t1/2)
timeFrame: Approximately 6 months
measure: Accumulation ratio (Racc)
timeFrame: Approximately 6 months
measure: Phase Ib: DOR
timeFrame: Every 8 weeks from first evaluation as CR or PR to the first evaluation as PD or death of any cause, whichever came first, assessed approximately 24 months.
measure: Phase Ib: PFS
timeFrame: Every 8 weeks from first evaluation as CR or PR to the first evaluation as PD or death of any cause, whichever came first, assessed approximately 24 months.
measure: Phase Ib: OS
timeFrame: From the first date of treatment until date of death, assessed approximately 48 months.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Guanzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Changchun
country: China
facility: Jilin Cancer Hospital
state: Jilin
city: Jinan
country: China
facility: Shandong Cancer Hospital
state: Shandong
city: Chengdu
country: China
facility: West China Hospital Sichuan University
state: Sichuan
Study officials:
affiliation: Sun Yat-sen University
name: Li Zhang, Master
role: PRINCIPAL_INVESTIGATOR
References: