Phase I Study of the BBP-398 in Patients With Advance Solid Tumors
About the study
This is an open label, dose escalation and expansion, two-part Phase I study for SHP-2 inhibitor BBP-398 to evaluate the safety, tolerability, pharmacokinetics, determine MTD and/or RP2D, and preliminary anti- cancer activity in Chinese subjects with advanced solid tumors and in Chinese subjects with advanced or metastatic EGFR-mutant NSCLC.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
1. Patients must have the ability to understand and the willingness to sign a written informed consent document 2 Patients must be willing and able to comply with the scheduled visits, treatment plan, laboratory tests and other specified study procedures 3. Age ≥18, male or female 4.Dose escalation: locally advanced or metastatic solid tumors Dose expansion: Advanced or metastatic EGFR-mutant NSCLC 5. Patients must have measurable disease by RECIST v1.1. 6. Patients must have an ECOG performance status (PS) ≤2 7.Patients with a life expectancy of ≥12 weeks. 8. Patients must have adequate organ function
EXCLUSION CRITERIA
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 SHP-2 inhibitor or any ingredients
- Treatment with any of the related anti-cancer therapies prior to the first dose of BBP-398 within the stated timeframes
- Patients with known active Hepatitis B, Hepatitis C infection, or HIV infection.
- Patients with any of the cardiac-related issues or findings
- Patients with a history of CVA, myocardial infarction or unstable angina within the previous 6 months before starting therapy.
- Patients with known central nervous system (CNS) tumors
- Patients with known active CNS metastases and/or carcinomatous meningitis.
- Patients with persisting toxicity related to prior therapy.
- Patients who have undergone major surgery within 4 weeks prior to study enrollment.
- Pregnant or breastfeeding female patients.
- Patients with inability to swallow oral medications or with gastrointestinal illness that would preclude the absorption of an oral agent.
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study Details
Contition
Advanced Solid Tumor,Advanced or Metastatic Non-small Cell Lung Cancer
Age (in years)
18 - 99
Phase
PHASE1
Participants Needed
7
Est. Completion Date
Mar 29, 2024
Treatment Type
INTERVENTIONAL
Sponsor
LianBio LLC
ClinicalTrials.gov NCT Identifier
NCT05621525
Study Number
LB1002-101
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