Phase 1 trial.

[Markdale]

I have been offered the chance to go on a phase 1 trial. The drug is bispecific antibody that works against cea producing cells and if there is progression whilst on the drug they will add an immunotherapy drug tislelizumab.
I refused to do more chemo and if I keep getting new nodules popping up in my lung there’s only so much that they can irradiate or cut out. the nodules are still small (but cea has increased to 20) so if it doesn’t work I’ll be able to try other things like sabr or surgery (hopefully).

[stu]

I can see your logic and think taking a trial at this juncture when you can address it with other options seems well thought out .

Particularly if the trail also has a back up plan !

I wish you every success.
Stu

[Peregrine]

Is your clinical trial one of these?

[Markdale]

Thanks stu, hope your mum gets better soon and the recurrence can be resolved.
Peregrine: #6. Would you have any advice?

[Peregrine]

... 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:

NCT03744468 

Company: BeiGene
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 Trials
https://www.fda.gov/patients/clinical-trials-what-patients-need-know/informed-consent-clinical-trials#Before_enrolling_in_a_

[Markdale]

Thanks peregrine. It helps alot

[Markdale]

I’ve started the phase 1 trial today for 2 drugs 1 binds to cea producing cells and the other to an immune cell my dose was the 2nd lowest at 15 mg weekly and will stay at that level for 8 weeks then a ct will evaluate if it’s been effective. If the Mets have progressed then they will offer another immunotherapy.

[prayingforccr]

I’ve started the phase 1 trial today for 2 drugs 1 binds to cea producing cells and the other to an immune cell my dose was the 2nd lowest at 15 mg weekly and will stay at that level for 8 weeks then a ct will evaluate if it’s been effective. If the Mets have progressed then they will offer another immunotherapy.

Rooting for you, markdale!

How many nodules have been identified?

[Markdale]

I’ve started the phase 1 trial today for 2 drugs 1 binds to cea producing cells and the other to an immune cell my dose was the 2nd lowest at 15 mg weekly and will stay at that level for 8 weeks then a ct will evaluate if it’s been effective. If the Mets have progressed then they will offer another immunotherapy.

Rooting for you, markdale!

How many nodules have been identified?

Thank you prayingforccr. likewise, your treatment is very interesting hope it works.

There are 4 nodules in the right lung and one in the left. I’ve had 2 treated with sabr almost a year ago but the larger seems to not have died and has a high uptake on pet scan.

[Markdale]

I have had 6 infusions of the trial drug, so far no observable side effects. I had a ct scan on Thursday and there was only a 1mm difference on the 2 nodules (sizes are approx 20mm and 30mm). However my cea dropped from 23 to 13. Hoping this is a positive sign, the oncologist said the treatment is based on the scan and not the cea but it could be a positive sign.

Mark

[nmorgen]

I’m assuming that the 1mm change was a reduction and not growth. If that is the case, congratulations because it seems to be working.

[prayingforccr]

I have had 6 infusions of the trial drug, so far no observable side effects. I had a ct scan on Thursday and there was only a 1mm difference on the 2 nodules (sizes are approx 20mm and 30mm). However my cea dropped from 23 to 13. Hoping this is a positive sign, the oncologist said the treatment is based on the scan and not the cea but it could be a positive sign.

Mark

Stable is good.

Does the drug continue to work once the infusions are ended?

[Markdale]

I’m not sure how long after infusions it’ll continue to work I guess as long as it’s attach d to their respective cells, but a risk is my body starts destroying the antibodies. In previous studies with similiar drugs some patients immune system started to fight angainst the antibodies.

[stu]

That’s a good result to me ! Stability is always welcome especially if the treatment is kind .
The drop in CEA is very interesting.
Have you had that type of drop on other treatments.?
Stu

[Markdale]

Thanks stu, it has never dropped like that but It never got that high before aswell even with the main tumour.
The 2 mets they are measuring have been treated with sabr but appeared to have some activity growth about 8 months after. A pet scan confirmed that there was activity consistent with growth. I saw the pet and the 2 areas were very bright ( I didn’t get the uptake value). They had an mdm and they viewed it as progression.
Part of my thinking is because sabr put a 1 or 2 cm margin around the Mets that maybe they can not tell proper growth or shrinkage. I believe it’s remained the same size since sabr, but there was some unusual areas around the treatment site that they thought was inflammation. The only thing that triggered the pet scan was the cea increase across 6 months, I asked if the cea could be explained by inflammation at the sabr sight and they said no bluntly.
So maybe sabr didn’t destroy the Mets and they grew again causing an increase in cea. Then I started the trial and the drug has had some effect on the Mets but it’s hard to tell that the Mets are shrinking because of sabr margin however the cea is decreasing because the Mets are decreasing as a result of the trial drug.
It could probably be something unrelated too.

Sorry if it incoherent I just wanted to write it down and I’ve had some wine