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Looks like starting at
"The Royal Marsden, NHS Foundation Trust Recruiting
London, United Kingdom, SM2 5PT
Principal Investigator: Professor Udai Banerji "
https://www.clinicaltrials.gov/ct2/history/NCT04969835?A=1&B=2&C=merged#StudyPageTop
status has been changed to "recruiting " and start date 16th July
https://www.clinicaltrials.gov/ct2/history/NCT04969835?A=1&B=2&C=merged#StudyPageTop
If Ava6000 was given to first patient on July 16th....and that patient feels well after receiving the chemo, you have your first indication that all could be going according to plan
It does state:
"Actual Study Start Date : July 16, 2021"
Which the glossary clarifies:
"Study start date
The actual date on which the first participant was enrolled in a clinical study. The "estimated" study start date is the date that the researchers think will be the study start date."
Which reads to me that AVA6K is already inside someone.
@Timster, hear hear!
Yes, a lot more at stake than the SP for some!
Assuming efficacy is established I am sure there will be no trouble getting 80 volunteers. You don't need to wait for the full cohort to start do you? Would have thought, no.
May 23 for last result report date will be shortened a fair bit too, I hope so as this is only phase 1a and 1b
Fingers crossed for the 80 !!
I hope for those 80 people this is a life changing and potentially life saving success...
80 participants!!!
fingers crossed this new Intervention: Drug: AVA6000 treatment will improve patient well being
very sick people involved in trials ,
"Drug: AVA6000 is a FAP-activated prodrug of doxorubicin. AVA6000 will be administered via IV infusion every 3 weeks. Dosing will occur based on the calculated patient's BSA on the day of dosing.
Study Arms ICMJE Experimental: AVA6000 Phase 1a
Patients in Phase Ia will receive escalating doses of AVA6000 following a 3+3 design, commencing with a starting dose of 80mg/m2, once every 3 weeks (Q3W) starting on Cycle 1, Day 1 (C1D1), until disease progression, unacceptable toxicities, withdrawal from treatment for other reasons, reaching maximum lifetime cumulative exposure to doxorubicin (or other anthracyclines), or death, whichever occurs first.
Intervention: Drug: AVA6000
Just to make my post above a little easier to read:
Contacts
Contact: Avacta Life Sciences +44 (0)1904 21 7070 clinicaltrials@avacta.com
Locations
United Kingdom
The Beatson West of Scotland Cancer Centre, NHS Greater Glasgow & Clyde
Glasgow, United Kingdom, G12 0YN
Principal Investigator: Professor Jeff Evans
St James's University Hospital, The Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom, LS9 7TF
Principal Investigator: Professor Chris Twelves
The Royal Marsden, NHS Foundation Trust
London, United Kingdom, SM2 5PT
Principal Investigator: Professor Udai Banerji
The Christie NHS Foundation Trust
Manchester, United Kingdom, M20 4BX
Principal Investigator: Dr Natalie Cook
The Freeman Hospital, Newcastle-upon-Tyne NHS Foundation Trust
Newcastle upon Tyne, United Kingdom, NE7 7DN
Principal Investigator: Professor Ruth Plummer
Weston Park Cancer Centre, Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, United Kingdom, S10 2SJ
Principal Investigator: Dr Robin Young
Sponsors and Collaborators
Avacta Life Sciences Ltd
More Information
Go to sections
Responsible Party: Avacta Life Sciences Ltd
ClinicalTrials.gov Identifier: NCT04969835 History of Changes
Other Study ID Numbers: ALS-6000-101
First Posted: July 21, 2021 Key Record Dates
Last Update Posted: July 21, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Qualified researchers may request access to individual patient-level data through clincialtrials@avacta.com
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Sarcoma
Neoplasms
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
it is a UK clinical trial NOT a US one.
Ophidian
Lots of exciting stuff going on in the back ground!!!
It was on the radio a month ago that royal marsden was trialing a new cancer targeting treatment
The Wife of the husband who was taking part was talking about. She said it was remarkable!!!
Zoom first link gmcc gave was USA trials
Registered but not yet recruiting.
Great news….
From https://www.clinicaltrials.gov/ct2/show/study/NCT04969835#contacts:
Contacts
Contact: Avacta Life Sciences +44 (0)1904 21 7070 clinicaltrials@avacta.com
Locations
United Kingdom
The Beatson West of Scotland Cancer Centre, NHS Greater Glasgow & Clyde
Glasgow, United Kingdom, G12 0YN
Principal Investigator: Professor Jeff Evans
St James's University Hospital, The Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom, LS9 7TF
Principal Investigator: Professor Chris Twelves
The Royal Marsden, NHS Foundation Trust
London, United Kingdom, SM2 5PT
Principal Investigator: Professor Udai Banerji
The Christie NHS Foundation Trust
Manchester, United Kingdom, M20 4BX
Principal Investigator: Dr Natalie Cook
The Freeman Hospital, Newcastle-upon-Tyne NHS Foundation Trust
Newcastle upon Tyne, United Kingdom, NE7 7DN
Principal Investigator: Professor Ruth Plummer
Weston Park Cancer Centre, Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, United Kingdom, S10 2SJ
Principal Investigator: Dr Robin Young
Sponsors and Collaborators
Avacta Life Sciences Ltd
More Information
Go to sections
Responsible Party: Avacta Life Sciences Ltd
ClinicalTrials.gov Identifier: NCT04969835 History of Changes
Other Study ID Numbers: ALS-6000-101
First Posted: July 21, 2021 Key Record Dates
Last Update Posted: July 21, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Qualified researchers may request access to individual patient-level data through clincialtrials@avacta.com
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Sarcoma
Neoplasms
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Is that in the US?
Thanks.
See locations https://www.clinicaltrials.gov/ct2/show/study/NCT04969835#contacts
Not yet recruiting?
That's excellent news.
FYI https://www.clinicaltrials.gov/ct2/show/results/NCT04969835?view=results