Phase I Study of the BBP-398 in Patients With Advance Solid Tumors (NCT05621525) | Clinical Trial Compass
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 range
18 Years – 99 Years
Sex
ALL
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Determination of Maximum Tolerated Dose (MTD) of BBP-398