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15-20 patients suggests 5 to 7 dose increases in a 3+3 study. We don't know how big those steps will be but it looks as if avacta have a target dose in mind that may achieve maximum clinical benefit with minimal side effects (therapeutic window). To increase the dose above this wouldn't yield any benefit. The target will be based on the preclinical info they have. I suspect the company are very excited that they have a potential dox changing drug - this arm is probably the make or break one. We know the effects of dox so does the tech do what it says o the tin - is it cardiac sparing.
They then move into the second phase where they will need more patients. My experience is clinical trials.gov is the go to source for info other than the company. The first phase will report Q1 hopefully (AS update). The centres involved are already detailed in that study summary.
https://clinicaltrials.gov/ct2/show/record/NCT04969835
The number of patients needed for the entire study will about 30-80.
I am hoping they may be able to skip phase 2 and go straight to phase 3 given the dox known data. However from an SP point of view the biggest moment is this phase 1a result. I'm relaxing until then since no news really is no news.
I have persuaded my partner’s mum to sign up for it, hopefully, but she may not be eligible because she is quite frail. No harm in trying though. She has nothing to lose.
Thanks Timster for reminding us of AS's update....specifically "up to six sites" and 15-20 patients for Phase 1a. It's conceivable the trial has filled the requirement.
@roundhowe - absolutely, but for those patients who are exhausting conventional protocols and getting to the end of their options, signing up for something not too far into the future becomes an option.
There is no set date for commencement of 1b is will be entirely data driven.
Simply expanding recruitment to more centres has to be seen as positive since more recruits required has to mean progression of the trial.
Ophidian
https://avacta.com/wp-content/uploads/2021/09/Avacta-Group-plc-Interim-Results-Final.pdf
slide 15
When is Phase 1b due to begin? If I was in hospital with pancreatic cancer I think I'd rather be treated with what's available .... now! Experimental or not.
at fear of being jumped on again might I suggest that perhaps as many more patients will be needed for phase 1b, the move to start recruiting potential patients can get underway once the phase 1a data suggests there will be a phase 1b - i.e. there will be a MTD worth dosing above the usual Doxorubicin standard dose - based on emerging tolerability data etc.
I see any move to open up recruitment as very positive indicators
Ophidian
Yes CO agree think other sites extract copy/ data from the official clinical trial register and display summary detail .
https://clinicaltrials.gov/ct2/history/NCT04969835?V_4=View#StudyPageTop
Phase 1a ----- "• 15 to 20 patients" -- might be able to complete that part in 3 hospitals guess depends on patient availability and perhaps also easier to manage across fewer sites to begin with etc .
-------------------------------------
For Phase 1a
• Objective: Assess safety and tolerability of AVA6000; determine MTD and/or recommended dose for further development
• Approximately 4 Cohorts to achieve MTD
• 15 to 20 patients
• Patient Population: Locally advanced and/or metastatic pancreatic, colorectal, non-small cell lung, breast, head and neck (SCCHN), soft tissue sarcoma, ovarian and bladder cancer
MTD - Maximum Tolerated Dose"
On the Centerwatch site at the bottom of the page, you can change the search radius around Sheffield to 250 miles and it shows you all 6 sites in the UK. Then you can contact any of them about the AVA6000 trials.
Don’t think that means they are all recruiting yet. I think this is just to let patients have more info upfront and preemptively express interest.
I think that the 80 patients is an expected number of participants across the whole of the phase Ia and Ib study, rather than a present requirement. We’re still doing slow and steady dose escalations in cohorts of 3 patients, to my knowledge.
Might be wrong, but looks like a study summary and notice that Sheffield (and 5 other sites) are included in the overall study design, rather than recruiting now.
Well done for finding this info, i`m from doncaster but i pass weston park every tuesday so chuffed to see these tests being carried out locally.
the up lift for me was to hear AS saying in his podcast that the first patient being dosed was being monitured closely and that he was very pleased with the results so far, And that the initial trials wouldn`t proceed if there was any indication of things not going very well.
so in a nut shell to see that we are asking for 80 patients is a huge positive step in the trials and so far everything seems to be going to plan.
An RNS to confirm this along with confirmation of the self test would be a huge re rating of the share price.
So much so that Ophidians Target he set of £2.50 10 days ago could be easily achieved.
Good luck all and fingers crossed for a positive and transforming week
Kong
On target for PK data end of year/Q1
It looks like they've added..'Soft Tissue Sarcoma'..
Still only 3 on patient wing and https://www.clinicaltrials.gov/ct2/show/study/NCT04969835?term=sarcoma#contacts
@gadgie, I'm not so sure that the website that you've linked is just giving the same details as we already know. It does say that it's updated today, which suggest that something has changed, but I think the Weston Park Centre is just the first location listed in a full list of 6 choices to opt to volunteer for. Having said that, it only seems to allow you to select Weston Park, so perhaps it's correct....but time will tell.
LFT .... Pocket Money ..... Let's Pray this helps the Volunteer's ! Could be a massive game changer
my thoughts exactly,per my muted response post.
Why are we obsessing about Ndn when we have it now confirmed that we have a 4th hospital at Weston Park who are now recruiting for AVA6k
reason i mentioned confirmed tomorrow ,because on the clinical trials .gov not showing ,but last updated 19th oct
that aimed at me, if so, rubbish ,not a deramp at all, read my history LTH who,s mega positive on avacta.
subtle deramp - Sunday evening here - what time is it where you are? Is it Monday with you?
Muted response ,hope its confirmed tomorrow,cheers.
expect https://bit.ly/2Zhjyc1 to be updated tomorrow
6 Locations ?
https://www.clincosm.com/trial/pancreatic-cancer-colorectal-nsclc-united-kingdom-ava6000
Looks like another Hospital recruiting ?
Weston Park Cancer Centre, Sheffield Teaching Hospitals NHS Foundation Trust