TerminatedPhase 1

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

Stopped: Business reason

China7 participantsStarted 2022-10-18

Plain-language 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.

Who can participate

Age range18 Years – 99 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Determination of Maximum Tolerated Dose (MTD) of BBP-398

Timeframe: Completion of 1 Cycle (28 days)

Determination of anti-tumor activity of BBP-398

Timeframe: Completion of 1 Cycle (28 days)

Trial details

NCT IDNCT05621525

SponsorLianBio LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-03-29

View on ClinicalTrials.gov More Advanced Solid Tumor trials