Has anyone heard of trial DB-1311-O-1001?

[Stefciaa]

Hi all, I’m wondering whether anybody has heard of the above trial?

My Dad had been put forward for this and was advised yesterday he got through onto the trial but the paperwork says “first trial on humans”. They aren’t sure of the side effects and we are all feeling a bit apprehensive…

My Dad has stage 4, Gleason 9, low volume CRPC, and his genome tests say he has a “rapid mutation gene”. We have tried pretty much everything over the last 6 years, ADT, docetaxel, Zytiga, radiation, keytruda (ended badly with severe pneumonitis), Xtandi and recently just timed out on Cabazitaxel.

We through whatever “herbs and spices” we can at it too when there are no contraindications.

Before this trial came up we were told he would be moving on to Lu177 and then carboplatin.

We are going to the hospital tomorrow to be briefed by the team managing the trial but I’m wondering / someone on here can shed some light or any knowledge on this?

Thanks you in advance!

[God_Loves_Me]

DB-1311 is antibidy drug conjugate (ADC) since it uses an antibody to find the cancer and it injects a chemotherapy drug into the cells. This is an important area of research today!

This is different from lutetium (pluvicto) which kills the cell with radiation

I also had similar opportunity to go for pluvicto. I had pre-approval in hands for pluvicto and dr suggest me to go for ADC

Source :

investors.biontech.de/news-...

DB-1311 is an ADC comprised of a humanized antibody and DualityBio’s proprietary DITAC linker-payload. It has exhibited potent antitumor activity in a range of tumor models representing multiple cancer types and has been well tolerated in preclinical studies, with a good pharmacokinetics profile. The wide therapeutic window demonstrated by preclinical antitumor activity and its safety profile support the potential of DB-1311 to address unmet medical needs across a broad range of cancers.

Questions - I would ask to mo

- What's the toxicity level ? Probably it is zero

- How many days DB-1311 stays in body if answer is less than 5 days then may not work great

- What are top side effects ? Probably dry eye, fatigue , may drop platelets

[TJGuy in reply to God_Loves_Me]

Did you end up going for ADC?

[God_Loves_Me in reply to TJGuy]

Yes ARX517. I got my first infusion on 6th May, and the next is on 28 May

[TJGuy in reply to God_Loves_Me]

Good luck let's all hope it proves successful!!

[God_Loves_Me in reply to TJGuy]

Thank you so much

[Stefciaa in reply to God_Loves_Me]

Thank you so much for the info and reply.

Soo we went to meet the team conducting the trial (which also consists of our MO) and Dad had to do bloods for kidney function and his creatinine correction level came back at 49 and it needed to be over 60 for him to continue on to the trial.

Since Dad had kidney issues a couple months ago and had a reaming procedure to widen his urethra his levels have been steadily improving so for that reason and that he hadn't drank any water prior to his blood test, they are going to retest him again next Thursday and see if it gets any higher. I'm not very hopeful that it will jump the 11 points required but fingers crossed.... otherwise we are on to LU-177.

What's the difference between ARX517 and DB-1311?

I hope you get great success with it and the side effects don't hinder you too much from enjoying life.

[God_Loves_Me in reply to Stefciaa]

Ok. I was in the same boat. I completed all scans, and they ran my blood, reporting similar or lower creatine functions. I am on tolvaptan to balance my sodium level. To qualify for clinical trials, my MO and Nurse started multiple IVs to bring my creatine level up. Within a day, I had 64 creatine levels. Please call your MO and request IV treatment to bring your creatine level up.

I do not know the difference between ARX517 and DB-1311. Please ask your MO and may be he is right person to answer.

ADC does not have severe side effects, mostly fatigue and dry eye. Plan to schedule longer meetings with your MO and make sure that you qualify for clinical trials and also understand the side effect

Important notes :

Please make a sure to have hepatitis penal negative. there are some ADC reported severe side effects for positive hepatitis penal.

[Stefciaa in reply to God_Loves_Me]

Oh wow! That’s amazing. Our MO is also the Professor undertaking the trials and he didn’t suggest any other measures he can take except for increasing water intake.

My Dad is going to speak to his renal specialist and ask if he can recommend anything. Do you know whether the IV’s you received were just regular fluid?

[God_Loves_Me in reply to Stefciaa]

I have been told there is no way I can drink that much water so hydration iv helped me

[Stefciaa in reply to God_Loves_Me]

So the update is we went from 49 to 55 so they are giving him until Wednesday to try get it over 60. I mentioned the IV and the MO is giving him 1L on Monday and another on Tuesday so fingers crossed we make the cut!!

Thank you so much for the tip, it might just be what we need to get us in!

[God_Loves_Me in reply to Stefciaa]

You are welcome As you know, I was in the same boat. Please call the doctor and schedule all the scans that are required for a clinical trial. Probably seven scans. It will take easily one month.

There is one term called 0 days, which means they do another blood work before six days of infusion. On the sixth day, the drug infusion will begin, and they need to do blood work on day 0. That day may report lower creatine levels again

Even on zero days, I had one more infusion to keep my creatine level up to date, which came up with a surprise to let them know in advance to schedule an IV infusion on zero days again.

[j-o-h-n]

Hello Stefciaa (Greek origin meaning crown- Ste-fa-nia -seen at Greek Weddings) your last post was 6 years ago.... so that means your dad is around 76 years old.? Well anyway where is he being treated (facility and location)? Thanks for the info....

Good Luck, Good Health and Good Humor.

j-o-h-n

[Stefciaa in reply to j-o-h-n]

Hi J-o-h-n, yes although it's polish in my case

Yes he is. Hoping for He's being treated at the Icon Cancer Centre in Greenslopes , Australia.

[j-o-h-n in reply to Stefciaa]

Thanks again and give your dear Dad my regards (and regards to you too).... Wishing you all -

Good Luck, Good Health and Good Humor.

j-o-h-n