Preliminary Clinical Trial Data for "Xilonix" - Currently in Phase 3 Trials for mCRC

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DK37
Posts: 510
Joined: Tue Sep 17, 2013 8:31 am
Location: San Diego

Preliminary Clinical Trial Data for "Xilonix" - Currently in Phase 3 Trials for mCRC

Postby DK37 » Tue Jul 07, 2015 2:08 pm

Knowing that I write about experimental CRC treatments in clinical trials, the Colon Club asked me if I knew anything about the experimental drug “Xilonix” that is currently in randomized Phase 3 clinical trials for mCRC https://clinicaltrials.gov/ct2/show/NCT ... nix&rank=2

Ironically I didn’t, it was under my radar – but upon looking into it, I thought it was worth posting about it here, in case anyone wants to discuss this trial with their MD.

Xilonix is not a “typical” anti-cancer molecule. It is a monoclonal antibody which neutralizes “interleukin-1α”. I won’t go into the scientific details here but a reasonable overview is at this link here from the company developing it: http://www.xbiotech.com/clinical/oncology.html The mechanism of action is unique since it has the “theoretical potential” to do a number of good things in advanced cancer patients, for example 1.) Direct anti-cancer activity 2.) Anti-metastatic activity 3.) Reverse cachexia/improve quality of life.

They published their Phase 1 clinical trial results last year in the journal “Lancet Oncology” http://www.sciencedirect.com/science/ar ... 451470155X . It was an “all-comers” dose escalation trial but it included 14 CRC patients. There were hints of activity in the trial – a mixture of quality of life/lean body mass improvements plus “hints” of anti-cancer activity in CRC (1/14 patients had tumor regression, the overall survival length on average for others was trending towards better than historical averages) – but interpretation of the data is limited due to the small number of patients in the trial.

They just released preliminary data from their much larger (in progress) randomized mCRC Phase 3 trial last week (on their website, not peer-reviewed).
http://www.xbiotech.com/about/news/xbio ... urope.html

There are signs of activity in CRC patients in this preliminary analysis. 61/98 evaluable patients had an increase in body mass (so reversing cachexia). 60% of patients reported improved quality of life. 2/93 RECIST evaluable patients had tumor shrinkage and 23/93 had stable disease. This data is only preliminary and has not been peer-reviewed but it is showing some potentially promising trends.

In theory it is an interesting drug because it not only could have a direct anti-cancer effect but it also could help in a quality of life/palliative sense for late stage patients with e.g. cachexia. It looks to me like it has the potential to be a positive addition to metastatoc disease management/quality of life if these trends continue and are confirmed upon final clinical trial analysis, in comparison to the placebo arm.

-DK
Last edited by DK37 on Wed Jul 08, 2015 7:11 am, edited 2 times in total.
6/4/2012 Dx Stage 3C CRC @ 40 yo. MSS, KRAS-WT, BRAF-WT, p53-mut
7/12 FOLFOX/FOLFIRI
2/13 NED!
8/13 Enlarged lymphs - Stable
10/14 Stage IV. Lung & Lymph mets. 5-FU+bev
3/15 Cetuximab
11/15 FOLFIRI + bev
11/16 Signs of FOLFIRI resistance (Lymph mets)
1/17 Palliative radiation for resistant mets
2/17 FOLFIRI + bev + Maraviroc (off-label)
3/17 FOLFIRI + Erbitux + Maraviroc (off-label)
MSS-CRC Clinical Trial Finder: http://trialfinder.fightcrc.org/
2016 Colondar 2.0 Model
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rwightman
Posts: 199
Joined: Sat Jan 17, 2015 6:50 pm
Location: Southwest

Re: Preliminary Clinical Trial Data for "Xilonix" - Currently in Phase 3 Trials for mCRC

Postby rwightman » Tue Jul 07, 2015 3:26 pm

Tom, as usual, you're a boss! Thanks for keeping all of us in the loop!
10/9/14 DX Age 50 - MSS
10/23/14 - Colon Resection - Stage II - 0/15 lympth nodes
12/30/14 - Stage IV - 1 liver met 2cc - Liver Resection - No lymph nodes and margins clear
3/10/15 - peri mets
3/15 - Folfox with Avastin - 7 tx
7/15 - HIPEC - 2 peri mets
10/14 - resection of abdominal met
11/12 - 5FU

pukalania
Posts: 454
Joined: Mon Aug 06, 2012 2:54 am
Location: Honolulu, Seattle

Re: Preliminary Clinical Trial Data for "Xilonix" - Currently in Phase 3 Trials for mCRC

Postby pukalania » Tue Jul 07, 2015 6:12 pm

Thank you so much for posting this !!! We are looking into this trial right now
wife 34 dx DH stage IV
Feb10 col res
May10 12 x FOLFOX
Aug12 tumor in sig colon,mets in liver
Aug12 Xeliri Ava
Oct12 xel celebrx rad
Feb13 liver/colon res
Sep13 ill reversal, fistula,
Folfiri SBRT,ADAPT ava
Apr 15 continued growth liver and lungs

Ceebo
Posts: 132
Joined: Sat Feb 14, 2015 9:15 am
Location: Southwest Michigan

Re: Preliminary Clinical Trial Data for "Xilonix" - Currently in Phase 3 Trials for mCRC

Postby Ceebo » Wed Jul 08, 2015 7:07 am

Thanks for the great information, Tom! We appreciate it so much! --Cindie
DH 64 Stage 4 on 4/14 ; cecal tumor; 5+ nodes ; mets to liver; colon resection
5/14 FOLFOX
9/14 - Liver surgery aborted; peri mets
10/14 CT mult.1-2 mm lung mets; FOLFIRI & Avastin
1/15 CT -liver & lung mets shrinking
3/15 PET - ? New met. site colon; CEA rising
7/15 Chemo has failed; looking for clinical trial
9/29/15 started TAS-102 trial
KRAS mutant; MSS

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DK37
Posts: 510
Joined: Tue Sep 17, 2013 8:31 am
Location: San Diego

Re: Preliminary Clinical Trial Data for "Xilonix" - Currently in Phase 3 Trials for mCRC

Postby DK37 » Wed Jul 08, 2015 7:25 am

I just found out that Maia had been keeping an updated thread on this drug for a couple years - so more good historical info in her thread below

viewtopic.php?t=39860

-DK
6/4/2012 Dx Stage 3C CRC @ 40 yo. MSS, KRAS-WT, BRAF-WT, p53-mut
7/12 FOLFOX/FOLFIRI
2/13 NED!
8/13 Enlarged lymphs - Stable
10/14 Stage IV. Lung & Lymph mets. 5-FU+bev
3/15 Cetuximab
11/15 FOLFIRI + bev
11/16 Signs of FOLFIRI resistance (Lymph mets)
1/17 Palliative radiation for resistant mets
2/17 FOLFIRI + bev + Maraviroc (off-label)
3/17 FOLFIRI + Erbitux + Maraviroc (off-label)
MSS-CRC Clinical Trial Finder: http://trialfinder.fightcrc.org/
2016 Colondar 2.0 Model
DK37 Science Posts List

smalltownmess
Posts: 84
Joined: Mon Aug 04, 2014 2:09 am

Re: Preliminary Clinical Trial Data for "Xilonix" - Currently in Phase 3 Trials for mCRC

Postby smalltownmess » Sat Jul 11, 2015 11:51 pm

My mom was scheduled to begin this trial on Wednesday but was unable to because of her hospitalization. Will be meeting with her MD on Monday and hopefully he will let us know when she can start. Thanks for posting this DK, hoping for good results!
Mom diagnosed Stage 4 with Liver mets 7/2011
July 11: Xeloda and Avastin
August 13: Irinotecan
June 14: Disease Progression
August 14: SBRT
October 14 - December 14: RRX-001
January - May 15: Irinotecan
May 15: One week Stivarga -- stopped b/c DRESS Syndrome
July 15: Disease progression
July 15: Start Xelox

MWiener
Posts: 1
Joined: Mon Aug 17, 2015 11:59 am

Re: Preliminary Clinical Trial Data for "Xilonix" - Currently in Phase 3 Trials for mCRC

Postby MWiener » Mon Aug 17, 2015 12:26 pm

Patients can use the attached link to find facilities in their area that either have the study open or are able to open the study. Use the "Continue" button at the bottom to determine qualification and receive more information.


http://xcitecolontrial.com/clinical-qua ... tionnaire/

info@xcitecolontrial.com

daniel.qin
Posts: 25
Joined: Tue May 26, 2015 9:07 pm
Location: Sunnyvale CA

Re: Preliminary Clinical Trial Data for "Xilonix" - Currently in Phase 3 Trials for mCRC

Postby daniel.qin » Mon Aug 17, 2015 2:13 pm

Thanks for the great information!

I will start this trail tomorrow.

-Daniel
39 years old Male
4/12 - colon surgery stage III
12/12 - 12 round FOLFOX
5/14 - met to spleen, colon surgery, spleen remove, radiation, XELOX
KRAS-mutated, BRAF wild type, MSI-stable.
11/14 - Abdomen wall met, surgery, FOLFIRI+Avastin
3/15 - CT, NED
Chinese herbs medicine
5/15 - CT, progressing-FOLFIRI+Avastin
6/15 - cannabis oil supplements
8/15 - Xilonix fail
10/15 - RRX 001

User avatar
DK37
Posts: 510
Joined: Tue Sep 17, 2013 8:31 am
Location: San Diego

Re: Preliminary Clinical Trial Data for "Xilonix" - Currently in Phase 3 Trials for mCRC

Postby DK37 » Tue Aug 18, 2015 8:46 am

If possible, please let us know your experiences with Xilonix Daniel - that kind of information is invaluable to fellow patients on this board!

Good luck & take care,
-DK
6/4/2012 Dx Stage 3C CRC @ 40 yo. MSS, KRAS-WT, BRAF-WT, p53-mut
7/12 FOLFOX/FOLFIRI
2/13 NED!
8/13 Enlarged lymphs - Stable
10/14 Stage IV. Lung & Lymph mets. 5-FU+bev
3/15 Cetuximab
11/15 FOLFIRI + bev
11/16 Signs of FOLFIRI resistance (Lymph mets)
1/17 Palliative radiation for resistant mets
2/17 FOLFIRI + bev + Maraviroc (off-label)
3/17 FOLFIRI + Erbitux + Maraviroc (off-label)
MSS-CRC Clinical Trial Finder: http://trialfinder.fightcrc.org/
2016 Colondar 2.0 Model
DK37 Science Posts List

Ceebo
Posts: 132
Joined: Sat Feb 14, 2015 9:15 am
Location: Southwest Michigan

Re: Preliminary Clinical Trial Data for "Xilonix" - Currently in Phase 3 Trials for mCRC

Postby Ceebo » Tue Aug 18, 2015 3:24 pm

Daniel, may I ask what location you are at to be in the trial?

We look forward to hearing more about your clinical trial journey. My husband and I are actively looking for a clinical trial for him to get into since chemo is no longer working for him.

Thanks,
Cindie
DH 64 Stage 4 on 4/14 ; cecal tumor; 5+ nodes ; mets to liver; colon resection
5/14 FOLFOX
9/14 - Liver surgery aborted; peri mets
10/14 CT mult.1-2 mm lung mets; FOLFIRI & Avastin
1/15 CT -liver & lung mets shrinking
3/15 PET - ? New met. site colon; CEA rising
7/15 Chemo has failed; looking for clinical trial
9/29/15 started TAS-102 trial
KRAS mutant; MSS


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