Status:
TERMINATED
BBP-398 in Combination With Osimertinib in Locally Advanced or Metastatic NSCLC Patients With EGFR Mutations
Lead Sponsor:
LianBio LLC
Conditions:
NSCLC
Eligibility:
All Genders
18-99 years
Phase:
PHASE1
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 an...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 29 2024
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT06032936
Start Date
July 27 2023
End Date
March 29 2024
Last Update
June 25 2024
Active Locations (5)
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1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
2
Sun Yat-sen University Cancer Center
Guanzhou, Guangdong, China, 510060
3
Jilin Cancer Hospital
Changchun, Jilin, China, 130012
4
Shandong Cancer Hospital
Jinan, Shandong, China, 250117