AMG-509 Clinical trial : Ok, so some... - Advanced Prostate...

Advanced Prostate Cancer

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AMG-509 Clinical trial

Unknown58 profile image
78 Replies

Ok, so some months back i mentioned the incredible results I have had on AMG-509, a Phase 1 Clinical Trial of a Bi-Specific Monoclonal antibody. I was one of the early pioneers who tried this novel infusion drug. I was Stage IV castrate resistant, with lesions in spine leg ribs,,,etc.....My PSA had climbed to 20 or so, from undetectable after 3 years of ZYTIGA failed. I was in deep trouble. Within a few weeks of the trial my PSA fell to 0.1 and my bone scan got cleaner and cleaner every 90 days, as did the CT Scan.

Happy to report I completed 44 weeks of Infusions of AMG-509, and at my request, we stopped the treatment, because from a science standpoint, i wanted to see what would happen. It was a bold and brazen move, but i felt we had to do it, so i told the docs "its time to find out what happens if we stop"....We stopped in early May 2022, in July we did a bone scan, it was clean. Former lesions at L1 and T4 of the spine were gone. No other lesions in any other area were visible. PSA is 0.1 still. We will do another scan in October, and another PSA. Stay tuned.

78 Replies
KocoPr profile image

Wow that is great news ! Im really glad for you and thank you for posting and keeping us informed.Is this the study

What part of trial did you do?

Drug: AMG 509

AMG 509 administered as an IV infusion (Parts 1, 3, 4 and 5) or SC injection (Part 2).

You said 44 weeks of infusions. Is that once/week

A phase 1 study of AMG 509 in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC).


Unknown58 profile image
Unknown58 in reply to KocoPr

i was brought in to take a Phase 1, dose escalation. The folks they had in their study had done .001, .01, and .1...i came in to try .3, a higher dose...they now have folks enrolled who are doing 1.0 I believe. Yes it was weekly, thru an IV

TJGuy profile image
TJGuy in reply to Unknown58

Thanks for the positive news and hope.

I'd think most of us would love to get off ADT with all the negative side effects, did this drug avoid the negative side effects of ADT?

How long does it take each week for the IV?

Do you know what the overall goal for the drug is? Lifetime maintenance every week for life or X number of infusions and coast for a period, repeat? Durable remission/cure?

Unknown58 profile image
Unknown58 in reply to KocoPr

I did not get involved in the injection version, as I felt until they perfect it, the reactions would be epic lol...the infusion means it goes in slow, lowers the chance of allergic reaction

swwags profile image

Fantastic news!

sszyszkiewicz profile image

I needed this today! Do you still have a prostate?

Unknown58 profile image
Unknown58 in reply to sszyszkiewicz

i do still have my prostate, they wanted to remove it i said no

Brysonal profile image

Wow.. fantastic news. Thank you for the update

Tall_Allen profile image

Great news! Can you restart if you want to?

Unknown58 profile image
Unknown58 in reply to Tall_Allen

That is iffy, but when the cancer comes back, i will certainly make that pitch to them !

sszyszkiewicz profile image
sszyszkiewicz in reply to Unknown58

Hopefully its “if”, not “when”.

Unknown58 profile image
Unknown58 in reply to Tall_Allen

I also wanted to say Tall Allen, that patients that came in before me at dose levels 1/10th of mine (.001, .01) i dont think it had the same success. I came in at .3, and ultimately dropped it down to the .1 Cohort, worked great. Let me also mention a story:

There was a patient who came in at the higher dose of 1.0, had significant pain as a reaction, pain that even fentanyl couldnt control, so he dropped out after one treatment...a month later, his PSA went from like 14, to undetectable lol lol....whether he re-entered the trial i do not know, but i know for a fact, after he dropped out after 1 treatment his psa was undetectable a month later !

Unknown58 profile image
Unknown58 in reply to Tall_Allen

Also Tall Allen, Amgen is working feverishly to figure out how to make it an injectable, because it would be easier to administer, rather than an entire day in a chemo infusion room, etc...also, if were going to someday market this drug, if it was an injectable, patients would be able to get the drug in thousands of more places, from the city to the boondocks, cuz we could just ship the's a work in progress, we shall see. I know the first time they did an injectable the guy had a full body rash and it was not good...but since then they are working on different techniques, one of which could be like a "DEPOT" (similar to Eligard, which it sits under your skin and slowly melts into the body over "x" period, but there are some significant technical challenges

Enasxristos profile image

Any side effects?

Unknown58 profile image
Unknown58 in reply to Enasxristos

only side effect i notied was body inflammation, which in me, manifested as shoulder pain and stiffness when i walked.

Longterm101 profile image
Longterm101 in reply to Unknown58

Where was the trial?

Unknown58 profile image
Unknown58 in reply to Longterm101

The trial is in many places, I took my infusions in Philadelphia at Jefferson. I was blessed and lucky to be one of less than 100 people who have ever gotten this secret drug.

Soumen79 profile image

Congratulations on this great result, you bring home hope, thank you!How is the broader resultset? Any idea how other participants are doing?

Unknown58 profile image
Unknown58 in reply to Soumen79

I know one participant in particular who was often in the infusion center when i was in there, and we exchanged phone numbers...his scans are very good, and i believe his PSA is low. Overall, as best i know, the study is going very well, with those taking doses equal to mine or higher.

Soumen79 profile image
Soumen79 in reply to Unknown58

So very encouraging...

addicted2cycling profile image
addicted2cycling in reply to Unknown58


Spyder54 wrote --- " ... Your Bio is empty ... "

I saw that also and was hoping that you might share the info ---only if you are comfortable doing so.

Unknown58 profile image
Unknown58 in reply to addicted2cycling

i updated my profile...i was one of those rare folks who was dying at diagnosis...see profile

Spyder54 profile image

I am so happy for you. I read online that AMG-509 is an immunotherapy drug that teaches T-cells how to find and kill cancer cells. I guess Amgen is involved? City of Hope is deeply involved too?Not sure what difference is between an infusion, vs an injection?

Gosh I hope this has durable remission and works on a wide audience of mCRPCa patients. Please keep us posted. Your Bio is empty so I know little of your journey, but read u must have 1 or 2 Taxane treatments to qualify.

Thanks, Mike

sszyszkiewicz profile image
sszyszkiewicz in reply to Spyder54

I dont think you need one or two taxanes if you read it carefully.

lokibear0803 profile image
lokibear0803 in reply to sszyszkiewicz

Correct, there is a cohort allowing no prior taxane exposure, if the patient has “actively refused” or is deemed “medically unsuitable”.

Now all we need is durable response. Already it seems, anecdotally at least, we have a modest side-effect profile.

With one location of City of “Hope”, indeed.

Unknown58 profile image
Unknown58 in reply to Spyder54

technically one is supposed to have done chemo before entering the trial, but i got that waived since i declined chemo. My bio is empty, but i was diagnosed in 2017 with Stage IV out of the gate...50 bone lesions, 364 PSA lol

spw1 profile image

wow that is great news. Good luck with future scans.

countrymusic101 profile image

Great news! Thank you for sharing. Gives hope for many!

Fight11 profile image

May I ask where was the trial being done? That’s great news.

KocoPr profile image
KocoPr in reply to Fight11

Here is the trial number NCT04221542

KocoPr profile image
KocoPr in reply to Fight11

Locations 19 study locations

United States, California

City of Hope National Medical Center Recruiting

Duarte, California, United States, 91010

University of California San Francisco Recruiting

San Francisco, California, United States, 94158

United States, Indiana

Indiana University Melvin and Bren Simon Cancer Center Recruiting

Indianapolis, Indiana, United States, 46202

United States, Louisiana

Tulane Medical Center Recruiting

New Orleans, Louisiana, United States, 70112

United States, Missouri

Washington University Recruiting

Saint Louis, Missouri, United States, 63110

United States, New York

Memorial Sloan Kettering Cancer Center Recruiting

New York, New York, United States, 10065

United States, North Carolina

Duke University Medical Center Recruiting

Durham, North Carolina, United States, 27710

United States, Ohio

Oncology Hematology Care Incorporated Recruiting

Cincinnati, Ohio, United States, 45242

United States, Pennsylvania

Thomas Jefferson University Recruiting

Philadelphia, Pennsylvania, United States, 19107

University of Pittsburgh Medical CenterCancer Pavillion Recruiting

Pittsburgh, Pennsylvania, United States, 15232

United States, South Carolina

Prisma Health Upstate Recruiting

Greenville, South Carolina, United States, 29605

United States, South Dakota

Sanford Health Recruiting

Sioux Falls, South Dakota, United States, 57104

Australia, New South Wales

Chris OBrien Lifehouse Recruiting

Camperdown, New South Wales, Australia, 2050

Australia, Victoria

Monash Medical Centre Recruiting

Clayton, Victoria, Australia, 3168


National Cancer Center Hospital East Recruiting

Kashiwa-shi, Chiba, Japan, 277-8577

Korea, Republic of

Seoul National University Hospital Recruiting

Seoul, Korea, Republic of, 03080

Asan Medical Center Recruiting

Seoul, Korea, Republic of, 138-736


National Taiwan University Hospital Recruiting

Taipei, Taiwan, 10002

Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation Recruiting

Taoyuan, Taiwan, 33305

Unknown58 profile image
Unknown58 in reply to Fight11

the trial is in many places around the world, i did mine at Jefferson in Philadelphia

GreenStreet profile image

Fantastic news . Congrats 👍

Prostatefighter profile image

Wow wow wow! Thoroughly delighted for you. How did you get onto the trial, where are you based?

Unknown58 profile image
Unknown58 in reply to Prostatefighter

I am in Philly, and when i declined chemo i said to my doc, who runs the research down at Jefferson "what else you got?" lol

Unknown58 profile image
Unknown58 in reply to Prostatefighter

It was definitely a wow moment...the shot heard round the world...Im a semi famous you tuber and it spread thru youtube shows as well...the scans with the cancer, then without the cancer, were jaw dropping

Prostatefighter profile image
Prostatefighter in reply to Unknown58

So happy for you! We are in UK and the standard of care seems the typical chemo and other high toxicity treatments. 😔

johnscats profile image

Hi so glad this works any side effects have stage 4 with bone Mets but as of now not visible in lmphnodes and lung rest of main organs a1

Unknown58 profile image
Unknown58 in reply to johnscats

no side effects at my dose level except some stiffness

SHH696 profile image

Did they test you for STEAP-1 expression level? 87% in general. Can you please update your bio? Gleason, mutations? Has anybody expressed certain markers as of specific interest?

Unknown58 profile image
Unknown58 in reply to SHH696

They did not test for STEAP-1 proteins, and my gleasons at diagnosis were 8's and 9's and i had enough bone lesions to kill 3 people...fortunately, the Hormone Therapy worked for 3 years, before i failed

Pianodude profile image


longleaf profile image

Happy for you and hoping it continues.

Rolphs profile image

Great! Thanks for sharing.

leo2634 profile image

What if any side effects did you have, also what were the frequency of infusions days, weeks, months? Congratulations on the incredible results gives all hope. Leo

Unknown58 profile image
Unknown58 in reply to leo2634

no side effects excpet inflammation and stiffness...the infusions are once per week

leo2634 profile image
leo2634 in reply to leo2634

So you had 44 infusions and I see it was your choice to stop. If you didn't stop how long would they continue. I also want to thank you for your contribution to all of us and giving us hope.

Izzygirl1 profile image

That's GREAT news!! So happy for you! ❤️

TJGuy profile image

It appears the study uses bone scans, and PSA tests to <0.1

Will the study use more specific testing such as PSMA, Choline, Axumin scans. MRI, ultrasensitive PSA as warranted for patients performing well like yourself?

If say your Oct PSA comes back <0.1 and bone scan is clear?

Was this at MSK?

Unknown58 profile image
Unknown58 in reply to TJGuy

I did not do the PSMA, or any of the more emerging advanced scanning theory is if i cant see it on a bone scan, I really dont care....lets face it, if we had better scans, half the world would prolly find tiny

Calhoun113 profile image
Calhoun113 in reply to Unknown58

Actually I got into a trial and had a PSMA scan because my PSA was creeping up .7. Showed bone lesions. A week later I had a regular bone scan which came up clear. I’ve been on ADT and Zytiga/prednisone for about 20 mos. PSA undetectable. If I relied on a regular scan I wouldn’t have had such aggressive treatment. PSMA seems the way to go. But good luck on your treatment. I slept better last night.

Longterm101 profile image
Longterm101 in reply to Calhoun113

When will u start the trial? What location

Spyder54 profile image
Spyder54 in reply to Longterm101

Longterm. He already completed the Trial, and asked to stop to see how long before PSA or Scans showed recurrence. HE IS N=1

Unknown58 profile image
Unknown58 in reply to TJGuy

I was at Jefferson in Philadelphia

Andy1569 profile image

Great News!!!Thank you for taking the risk, "but i felt we had to do it, so i told the docs "its time to find out what happens if we stop", and sharing your stats with us all!

Unknown58 profile image
Unknown58 in reply to Andy1569

It was a big risk, but Im a Day Trader (some of you have already figured out who I am lol) and so im used to risk lol

Andy1569 profile image
Andy1569 in reply to Unknown58

I’ve done a little day trading in my time. I think you know the difference. 😉. Take care worrior brother

Cmdrdata profile image

Great news. I have been on Zytiga/AA for 4 years and now PSA begins to climb again. I told my Onc that next step would be A clinical trial so I can help this community and the doctors find a “cure” instead of just going from drug to drug. You are helping us and the researcher with your decisions. Thanks.

samuelachglue1952 profile image
samuelachglue1952 in reply to Cmdrdata

That is also my attitude. At this stage, help mankind any way available.

Yank66 profile image

Thanks for spreading hope this morning. DH is undergoing Chemo now and has been discouraged lately. Just what he need to hear.

GoBucks profile image

Awesome report. Wishing you continued good news. Thank you so much for participating in that trial.

Unknown58 profile image
Unknown58 in reply to GoBucks

Fingers crossed ! so far so good...I went from near death to we cant find the cancer

jazj profile image

Thanks for sharing. What is most encouraging other than the great results is the apparent minimal side effect profile! Typically in a Phase 1 dose escalation study, there can be some pretty nasty side effects. I commend people with the courage to blaze the trail for the rest of us by entering a Phase 1 Trial. Let's hope it's not similar to other new therapies that show only a temporary short-term remission. I see the primary complete is close to 3 years out. Then Phase 2 and 3 will be required. So If you are metastatic castration resistant, this would be one to have your Oncologist keep an eye on to get you into Phase 2 if Phase 1 goes well, or even see if you can be added to Phase 1 if Unknown58 continues to see good scans and PSA results. I think this type of user reporting is some of the most valuable information you can get here.

Spyder54 profile image
Spyder54 in reply to jazj

Agreed JazzJ. Agreed! Mike

Unknown58 profile image
Unknown58 in reply to jazj

Thanks Jazj, yes if my cancer comes back, i will be asking Jefferson to make the drug for me, maybe do 10 weeks in a row, beat it back, buy a few more years. I personally believe AMG-509 is the ONE...its a game changer

Sunlight12 profile image

Wow - very exciting results! Thank you for sharing..and very best wishes to you as your health journey continues!


lokibear0803 profile image

Thank you so much for sharing this. This is fantastic news for you, and quite possibly for many of us here.

Do you know when the trial will conclude and announce results?

Thank you again. To echo other thoughts here, wow!

Unknown58 profile image
Unknown58 in reply to lokibear0803

So, we should be wrapping up the phase 1 dose escalation soon, then im not sure what their plans are. Personally, I have sent messages thru private channels that they need to speed this up, THIS is the my opinion.

Lavender22 profile image

Such good news. And thank you for participating in this trial. I remember reading your report on the trial back in February. I read your current report to my husband over coffee this morning and said, you know, this really sounds like something. He has a similar profile to yours but is into about 18 months of Abiraterone. And now looks like something good on the horizon if and when it fails - AMG 509! Keep us posted. And best of luck to you.

Unknown58 profile image
Unknown58 in reply to Lavender22

AMG-509 in my view, is the G.O.A.T. so far, of anything i have heard of.

Lavender22 profile image
Lavender22 in reply to Unknown58

I’m glad to hear that. Very glad. Especially coming from the horse’s mouth:). We are lucky to have you in our ranks… speaking for my husband here.

Yadifan profile image

Thank you for the update! Wow! Amazing and hopeful results! You have many followers (fans) that are cheering you on and wishing you continued success!

Unknown58 profile image

I will add, that of all the things i have heard of, this AMG-509 is the G.O.A.T....its insane, how it just gobbles up the cancer lol...wild.

GummyToad profile image

Frustrating that you need to be castrate resistant

traxcavator profile image

By the numbers: Assuming that in the presence of androgen, the PSA number is roughly proportional to the number of cancer cells. Since the cells replicate by dividing, the doubling time for PSA should give a good idea of how fast the thing may be growing/how many cells there are.

If AMG 509 or something else kills most of the cells (reflected in PSA number), it would be starting again from a very small source. That would require many doublings to become large enough to be back to where it was.

Whether or not it wipes the thing out is TBD. If it just buys time, it seems likely the time bought will be measured in years. Whether it can work a second time, or whether the cancer learns to defend against it will become known as time goes by.

Thank you for a dose of hope.


Unknown58 profile image
Unknown58 in reply to traxcavator

excellent summary John !

Blueslover profile image

This is totally amazing and very hopeful!

Gabby643 profile image

Thanks for all your updates, inspirational!

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