Are you currently (or have you been) in a Clinical Trial?
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Had scans on Monday and they showed significant progression in my lungs and liver. So devastated and scared as this is happening when I have really only one treatment option left, Halaven. I can't take Enhertu unless my lungs get better. They were able to switch me to Halaven on Tuesday. I am also on 25mgs of Prednisone to help me breathe. One bright thing is that my lung and liver seem to still be functioning normally. My oxygen saturation and bloodwork were all good.
Trying to get into a Phase I trial of ARX-788 at USC or a Phase I trial of Zenocutuzumab (MCLA-128) at Stanford.
The trial at USC would mean I'd have to fly, drive or temporarily stay down in LA. I don't mind doing that because both of my kids live in LA and my Chinese Traditional Medicine doctor is also there.
Started taking a low dose of the antidepressant, Remeron, to help me with anxiety and sleep. I really wanted to avoid taking an antidepressant but I need something to calm me down.
- Susan
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Below is a link to a lecture from a year ago at Stanford where Dr Steven Rosenberg is discussing his trial that provided a cure for Judy Perkins. The trial is currently 'suspended', 11 years after it started, but there are others working on these and other CAR-T therapies.
I thought it was interesting where, at about 25-28 minutes in, he shows scans from four different patients who were all in bad shape and now seem to be cured (5+ years out). The breast cancer patient he discusses is Judy Perkins, they made T cells to attack four different proteins that were on the surface of her cancer, interestingly, none of these proteins were thought to be needed for growth of the cancer (ie they were unlikely to be "driver" mutations). Usually if a protein is targeted by a drug, and its not needed for the cancer to grow, then the cancer just mutates to get rid of it, so it can grow in the presence of the drug. By hitting four proteins at one time, the cancer could not figure out how to mutate and get rid of all of them at the same time, so it could not escape. This is the reasoning behind combining drugs, it forces the cancer to make multiple specific mutations, making it far harder for the cancer to start growing again. Upon adding Keytruda they were getting up to 25% of patients to respond, very encouraging.
The Q&A discussion at about 45 min on is also very interesting. He is asked how this would not be just prohibitively expensive, and says yes but if its a cure its totally worth the cost, of course. Moreover, they are identifying more antigens that are unique to cancers (a limiting step in CAR-T), like ROR1 for TNBC, HER2, etc.. In addition, a universal cancer antigen, on every cancer but not on normal cells, was identified a couple years ago, so presumably studies to use that in trials are ongoing.
https://med.stanford.edu/cancer/training/events/fr...
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Susan, both of those trials look very promising, in that they are very specific targeted therapy- one for HER2 (either -low or -high expressing) cancers, and the other for NRG1 fusion proteins. From a recent paper on ARX788:
"Similarly, ARX788 significantly inhibited tumor growth, and generally outperformed T-DM1 in HER2-high and HER2-low expression xenograft models. Breast and gastric cancer patient-derived xenograft studies confirmed strong antitumor activity of ARX788 in HER2-positive and HER2-low expression tumors, as well as in a T-DM1-resistant model. The encouraging preclinical data support the further development of ARX788 for treatment of patients with HER2-positive breast and gastric cancer, including those who have developed T-DM1 resistance, and patients with HER2-low expression tumors who are currently ineligible to receive HER2-targeted therapy."
It is a next-gen ADC, and they show that it is stronger than Enhertu..The ARX788 trial at UCLA is headed by Sara Hurvitz, a real HER2 guru, so for her to pick it up must be really promising...
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Susan, sorry to hear of progression. Really really have all my good thoughts going to you for one of these trials to work for you. I too have to travel to be on trials & it's exhausting but worth it if they work. Best thoughts, cheers, dee
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I am wondering if it is totally useless for bone only people to even try to get into a trial??
I know that I will have to switch soon - but, if still bone only- I won't qualify for any trials-
Any bone only openings in these trials?
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NKB - My MO and I have discussed the bone-only question related to trials. I did participate in a trial as bone-only and I have seen another trial since then, but there aren’t many.
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Nkb, It's both a good question, and a good 'problem' to have..
The ARV-471 PROTAC trial Dee was on allows both "measurable and non-measurable" lesions, which I think means cancer can be bone-only- one arm provides ARV-471 + Ibrance. Requires prior I-F treatment, and accepts up to 3 chemos in the metastatic setting
https://clinicaltrials.gov/ct2/show/NCT04072952
Probably most of the SERD/SERCA trials would allow bone-only?
Here is the OP-1250 CERAN trial, is not very restrictive:
https://clinicaltrials.gov/ct2/show/NCT04505826
The SERD elacestrant has already finished its phase 3, concluding
"The trial results being statistically significant demonstrate a clinically meaningful improvement of PFS in the elacestrant group versus endocrine standard of care in patients previously treated with endocrine therapies and CDK 4/6 inhibitors."
They won't tell us the results, in terms of PFS, until San Antonio meeting next month, however if you don't need to switch immediately, you could wait and get it without a trial once FDA has approved it, and then combine it with Verzenio, etc
Here is a phase three for the SERD giredestrant, there have lots of sites in the bay area
https://www.clinicaltrials.gov/ct2/show/NCT0454600...
They say "bone only disease must have at least one predominantly lytic bone lesion confirmed by CT or MRI which can be followed"
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Thank you cure-ious for this info esp re ARV-71- sounds like I am the “perfect” candidate and meet the criteria - UCLA isn’t totally unreasonable for me
My UCSF MO told me that you have to have a “2cm hole in your bone” to qualify in some of these studies willing to take bone only. she also says that they often say they want a biopsy- but, she isnot sure a bone biopsy would count.
It does sound like things are opening up with options and I do hope that some will get approved soon so we all can have a chance at them.
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Moissy- that sounds great. What study were you in?
My MO might be too jaded to be open to looking- but, maybe she will surprise me. I am not officially progressed, but, tumor markers climbing, which usually means all is not well.
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Cure-ious, Thanks for the validation on the ARX-788 drug. I don't think I read anything about the NRG1 fusion in any of my genomic profiles. I know it is required for the trial at Stanford. Hope said she sent my genomic reports to Stanford so I guess they can figure it out?
Dee, Appreciate your kind words. I don't mind going to LA for treatments so hopefully that will work out.
Hugs, Susan
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Susan, I'm so sorry to hear about your progression. I hope you can get into one of the trials you are looking at.
Grannax, I hope you find something that can keep your cancer stable.
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Thanks Simone! My MO confirmed that I qualify for the trial but won't feel comfortable until I'm actually enrolled. Nervous that it will fill up but she wants to wait until after my 2nd week of chemo next Tuesday so we can have more time since I am off on the 3rd week.
Hugs, Susan
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Susan, NRG1 is a ligand (protein that binds and activates) HER3, so this is the same general signaling pathway as HER2. The Stanford trial inactivates HER3 signaling, which is often turned up when cancer cells escape the HER2 inhibitors. If either/both of these work, the Her2-specific CAR-T could go on your list as well..
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Thanks for the explanation, Cure-ious. I am HER2 IHC 2+ equivocal and have ERBB3 gene mutations. My IHC number was technically 2.5 so could be rounded up to positive. Not sure what this all means for NRG1 fusion.
My MO is trying her best to help me but she is so busy and there isn't a resource at UCSF to help us find trials. Does anyone know if there are other resources that can help me do this?
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Susan,
I haven't found any easy ways to sort through these, but here are a couple of sites that could maybe help you:
https://metastatictrialtalk.org
https://www.metavivor.org/mbc-prep/clinical-trial-search/
https://www.cancerresearch.org/en-us/patients/clin...
I know there are more, but this can give you a start. Of course, you can also sort through clinical trials.gov, but that one is a behemoth and can be very confusing.
Hope this helps even a little bit.
Bev
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Bay area buddies
UCSF has ARV 471 according to someone I met online. She was accepted there. Please reach out to their trial department to see if you qualify.
Dee
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Thanks BevJen! Will check out those sites. I was using MBCConnect but it didn't seem comprehensive. When I've been on trials before they have been at UCSF so all the coordination was taken care of. I don't know how much time it would take to try to get on one on my own.
AlabamaDee, I didn't know that UCSF joined the trial site group. Too bad I don't qualify for that trial since I have been on Xeloda, Abraxane, Trodelvy, Gem/Carbo and now Halaven.
Has anyone tried to get access to a trial drug though the Early Access Program or Right to Try?
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I've been trying to post a link to a new trial that will be opening up by the first of the year, but I must be gaga from the time change because I can't seem to do it It will be open to various types of late-stage cancers including TNBC.
Just Google MEM-288 and you can read all about it as well as follow the links to the trial.
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Wow, this one looks interesting. If I am reading it correctly, though, the only BC candidates are trip negative.
What caught my eye was the reference to dendritic cells near the beginning -- there was a study that closed maybe a year or two ago regarding dendritic cells (I think these are being looked at more in Europe?) and I wrote to the head person a couple of times, but they didn't have any reports ready.
Very interesting. Thanks Katty and Husband11. I hope this one opens up to more types of BC.
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Husband that looks great but it says NOT YET RECRUITING????
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Nicole,
I'd contact the sponsors -- there were a couple listed. See what they say.
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Bev. I sent the trial to my MO and told her it said not yet recruiting but that it also says it would start Nov 2021...and asked if she thought it would be a good fit for me and could she contact DUKE.... I see its only at Duke and Moffitt (Florida) I am only like 3 and half to 4 hours from Duke its do-able
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That is an exciting trial!; Nicole the press says it opens Dec 31 of this year. But you still might want to wait a bit, this first part is just 18 patients, so should go quickly, and for the next phase they say they would add on immunotherapy.. Also, they say you should have had prior immunotherapy
https://www.businesswire.com/news/home/20211103005...
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'curious....im sorry I thought MEM WAS immunotherapy?
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"MEM-288 is an oncolytic adenovirus encoding transgenes for human interferon beta (IFNß) and the company's proprietary recombinant chimeric CD40 ligand. MEM-288, armed with Memgen's proprietary CD40 ligand, leverages a validated target that powerfully activates the patient's immune system. The company's proprietary CD40 ligand has been evaluated in earlier clinical studies and demonstrated significant immune activation without the toxicity that had previously prevented development of safe CD40-based therapeutics. Because the CD40 system works as a master "on switch" for the immune system upstream from the immune checkpoint inhibitors, it holds promise in those patients whose disease has progressed despite treatment with immune checkpoint inhibitors."
It is clearly an immune based therapy on its own, but perhaps it might be enhanced by an additional immune based therapy.
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NIcole, immunotherapy is a super broad term. It includes all sorts of checkpoint inhibitors as well as immune stimulators.
Their inclusion criteria include "Progressed following therapy with at least one PD-1 or PD-L1 checkpoint inhibitor (regardless of PD-L1 expression status), except for patients with pancreatic cancer" So you'd need to progress on keytruda or tecentriq
Also, they inject the med right into the tumor so it needs to be accessible. It's not an IV med.
super interesting. I'd qualify for it when I progress but I don't know whether I'd be up for it...
https://clinicaltrials.gov/ct2/show/NCT05076760
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That’s an interesting trial. I will be following it since I am triple negative. Gosh, do they inject all your tumors? I have scattered lung nodules - some are under 1cm and would not qualify but if all my lung nodules did qualify would they inject all of them? I am exhausted just thinking about it.🤣
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