Phase I Study of the BBP-398 in Chinse Patients With Advance Solid Tumors

• Status: Recruiting
• Trial end date: 2024-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: LianBio LLC

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. ECOG performance status (PS) ≤2 7. Patients must have an ECOG performance status (PS) ≤2 8. Patients must have adequate organ function

Exclusion Criteria:

1. Patients with a known additional malignancy that is progressing or requires active treatment

2. Patients who have previously received a SHP-2 inhibitor

3. Patients who are hypersensitivity to SHP-2 inhibitor or any ingredients

4. Treatment with any of the following anti-cancer therapies prior to the first dose of BBP-398 within the stated timeframes

5. . Patients with any of the cardiac-related issues or findings

6. Patients with known central nervous system (CNS) tumors

7. Patients with persisting toxicity related to prior therapy

8. Pregnant or breastfeeding female patients