BBP-398 in Combination With Osimertinib in Locally Advanced or Metastatic NSCLC Patients With EGFR Mutations

LianBio

Status and phase: Terminated; Phase 1

Conditions: NSCLC

Treatments: Drug: BBP-398; Drug: osimertinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT06032936

LB1002-102

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

BBP-398 + Osimertinib

Experimental group

Description:

Phase Ia (Dose Escalation): Dose level 1: (starting dose level) The one lower dose level than RP2D of BBP-398 monotherapy in Chinese patients (RP2D -1) with Osimertinib 80 mg Dose level 2: RP2D The same dose level to RP2D of BBP-398 monotherapy in Chinese patients with Osimertinib 80 mg Note: The dosing interval and regimen might be changed based on emerging data of Study NAV-1001, LB1002-101 and this study. The proposed new dosing regimen will be submitted in a memo to EC for approval before execution. Phase Ib (Efficacy Expansion): Osimertinib 80mg QD + BBP-398 RP2D QD

Treatment:

Drug: osimertinib

Drug: BBP-398