Markdale wrote:... Peregrine: #6. Would you have any advice?
Yes, I have some advice, but I don't have time right now to go into all of the fine details.
You would be on trial # NCT03744468 which is a phase 1 trial focussing mainly on dose escalation sequences to determine a patient's maximum tolerated dose (MTD) of the drugs involved in the trial. And this is where the potential problem is. They will be doing dose escalations until you simply cannot stand it anymore, and that might trigger a serious adverse event (SAE) that might cause permanent damage to some part of your body from which you cannot recover.
This has happened in the past on this forum where the patients didn't know exactly what they were getting into when they signed up for a Phase 1 dose escalation trial.
So, my advice would be to learn as much about the trial protocol as you can so that you can avoid finding yourself in a difficult situation. You need to be well-informed about all of the protocol requirements so that you can act appropriately when you are on the trial.
Here is some basic information on the trial:
https://www.beigene.com/our-science-and ... s/pipeline
Drugs: BGB-A425, LBL-007, Tislelizumab
Phase 1-2 Study Investigating Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Various Combinations of BGB-A425 and LBL-007 With Tislelizumab in Patients With Advanced Solid Tumors
Phase 1 Dose Escalation and Phase 2 Safety lead-in: Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
A TEAE is defined as an AE that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study drug up to 30 days following study drug discontinuation or initiation of new anticancer therapy, whichever comes first.
An SAE is any untoward medical occurrence that at any dose results in death or is life threatening
========Informed Consent for Clinical Trialshttps://www.fda.gov/patients/clinical-trials-what-patients-need-know/informed-consent-clinical-trials#Before_enrolling_in_a_