English Community

ARC101

A Phase 1 Study of ARC101 in Advanced Solid Tumors

START DATE TO BE DETERMINED

The trial nurse called and we had a nice little chat about moving forward with this trial.

• She confirmed that the sponsor has approved a space for me  
• I have a pre-screening appointment next week (paperwork)
• She made the appointment for the afternoon. There is a shorter wait in the afternoon! She knew I was from out of town and she accommodated what works for me. This also means I should be able to do the GO train to/from same day - no overnight! Time is comparable to driving in. I have to drive 1.5 hours to the GO station and then it's about an hour to Union and a hop on the TTC to PMH. More relaxing not having to drive into downtown Toronto!! 
• She is going to see if she can send me the trial consent package. Some trials do not allow this.
  
• Just checked my email - the consent package has arrived! Having this package ahead of time will allow me to review the details for the trial and prepare questions so I'm ready for my appointment. This step is so important. Otherwise, you're stuck in the Dr office reading the details, preparing questions and trying to make a decision. Or, you leave with the information and have to come back with your decision and to formally sign the consent. 
• She is going to check to see if there is enough tissue sample from my last biopsy (in May) and if that would be acceptable for submission. I really don't want to undergo another biopsy so soon so I'm hoping this works out.
  
• My 28-day washout since previous treatment is next week, so I'll  be good to go.
• My last CT was done last week. I believe it has to be done within 28 days of the start of the trial. So, I'm good on that one, too.
  
• I'm sure there is going to be pre-trial blood samples required too. Not sure when we'll do that. 

Well, I think that's it for pre-screening prep for me.

NOTE

This trial just opened yesterday so the nurse is just getting familiar with the required process herself. I expect there may be some things we have to figure out on the fly…but I have no doubt they will accommodate my out-of-town timetable if they can.

@GloHo I'm so pleased that you have been given a space in the trial. It constantly amazes me how these things work. I'm so glad the trial nurse is able to provide so much advance information to get your prepared. Keep us posted.

Hi @GloHo ... checking in to see if you have any more information relative to the ARC101 trial timelines etc. I hoping things are continuing to progress forward for you.

-------------------------------------------

@Alwayslearning

Thanks for thinking of me. I have been going crazy...this is definitely a process...especially mentally.

I have had my first small dose and all went well. Repeat with increased doses and overnight hospital stays for the next two weeks 😵.

I have my notes and will pull something together to update my clinical trial experience.

-------------------------------------------

@GloHo wishing you much luck on this trial 🤞

-------------------------------------------

ARC101

A Phase 1 Study of ARC101 in Advanced Solid Tumors

Pre-Screening

Paperwork reviewed, questions asked and answered, and documents signed. Wait for sponsor to determine if there is space for me in the trial.

Screening

• Tissue sample available. No biopsy required.
• Blood work
• ECG

Before I even began the trial, I was almost out because one of my blood counts...AST (liver enzymes)...was just over the highest limit allowed. So, we crossed our fingers and decided to do another blood test prior to Day 1 and hope that it decreased to within the parameters of the trial. It did!!

This is also the time I get into details about which pre- and post-meds will be administered. I cannot tolerate Benadryl and always negotiate an alternate. Cetirizine is the alternate I have received for the last two trials. Tylenol is also a bit iffy for me. It makes me drowsy and has been known to elevate my liver enzyme counts. I just forewarn them that if my liver enzymes do start to spike, that I will be asking them to either reduce the acetaminophen or to provide an alternate drug.

I try to be proactive and self-advocate in this respect. I know how I react to these OTC drugs and I try to get in front of it before the trial begins.

My trial was postponed by one week because we had to wait for the sponsor to provide final approval for participation. Since we did not know what time we might receive the response the following day, which was my Day 1, the decision to postpone was made.

Schedule

The first schedule they presented was very confusing. I was very happy to see that before I started Day 1, the schedule had been revamped and is much more doable!! Especially for an out-of-town patient.

Cycle 1 (28-days)

Pre-Day 1 (overnight Lodge)

• Blood/ECG
• Clinic

Day 1 (overnight hospital)

• Check in for infusion and overnight hospital stay
• Pre-meds: Ondansetron, Dexamethasone, Cetirizine and Acetaminophen
• ECG immediately before and after infusion
• Infusion (step-up slow dose #1) = 2 hours. This is a slow-infused small dose to start that will be increased over the course of three weeks until you reach the maximum planned dosage for your arm of the trial.
• Saline drip = 4 hours
• Blood work at regular intervals
• Vitals at regular intervals
• Cognitive tests at regular intervals - this includes stating date, time and location, identifying objects in the room, writing a sentence
• Record urine output following infusion
• Post-infusion meds (start 12 hours following infusion and continue for two days for step up doses): Ondansetron, Dexamethasone, Cetirizine and Acetaminophen
• Pick up take home meds: Loperamide (diarrhea - as needed) and Olanzapine (nausea - as needed)
• Mouth rinse: Baking soda rinse to offset potential mouth sores

Day 2 (hospital/home)

• Early morning vitals and cognitive tests
• Blood work
• Dr visit for physical exam, eyesight, cognitive tests, hand/eye coordination, writing test - approve discharge
• Meds: Acetaminophen (every 6 hours), Ondansetron, Dexamethasone and Cetirizine (every 12 hours)

Day 3 (home)

• Acetaminophen (every 6 hours)
• Ondansetron, Dexamethasone and Cetirizine (every 12 hours)

Side effects

Dexamethasone + Ondansetron = CONSTIPATION!! By the fourth day, I had increased my nightly Senokot to two tablets, added a morning Senokot, and sent my hubby to store for prune juice 😁. Thankfully this combination finally did the trick.

I did notice that my mouth felt dry and fuzzy at one point. It did not last long and resolved itself. 

I also had a slight rash(?) on the side of my cheek (I think it was just the way I slept on that hospital linen🤣)

Pre-Day 8 (overnight Lodge)

• Blood/ECG
• Clinic

Day 8 (overnight hospital) 

• Check in for infusion and overnight hospital stay
• Pre-meds: Metoclopramide, Dexamethasone, Cetirizine and Acetaminophen
• ECG immediately before and after infusion
• Infusion (step-up slow dose #2) = 2 hours
• Saline drip = 4 hours
• Blood work at regular intervals
• Vitals at regular intervals
• Cognitive tests at regular intervals 
• Record urine output following infusion
• Post-infusion meds: Metoclopramide, Dexamethasone, Cetirizine and Acetaminophen

Needless to say, when I came back the following week for my next infusion, I negotiated an alternate for one of the culprit constipation drugs! They swapped out Ondansetron for Metoclopramide. I did my two evening Senokot and did not have an issue the following day! 

Day 9 (hospital/home)

• Early morning vitals and cognitive tests
• Blood work
• Dr visit for physical exam, eyesight, cognitive tests, hand/eye coordination, writing test - approve discharge
• Meds: Acetaminophen (6 hours), Metoclopramide, Dexamethasone and Cetirizine (every 12 hours)

Day 10 (home)

• Acetaminophen (every 6 hours)
• Metoclopramide, Dexamethasone and Cetirizine (every 12 hours)

Side effects

Face flushing from the Dexamethasone. This is normal for me. A little tired again but offset a bit by Dex. No issue with constipation this time thanks to the med change. Other than that, I am feeling well and hope to get back to pickleball when my schedule will allow it.

NEXT STEPS

I have completed the step-up dosing schedule. The next step is to receive the final full trial dose next week. This does include another overnight hospital stay 😵‍💫. Best place to be if anything should crop up, I suppose. To complete Cycle 1, I will come back the week after infusion for blood work only.

Beginning Cycle 2, the schedule will be 21 days with infusion Day 1, blood Days 8 & 15.

NOTES

Overall, I am feeling well. With the change in drugs, I'm hoping constipation is not going to be an issue. If it is, at least I'll have a plan in place for relief.

I do feel a bit drowsy from the meds but I think the Dex has offset that somewhat and it's not really interfering with my day-to-day activities. If I feel I really need to rest…I rest.

TRAVEL

I would be remiss if I did not touch on the out-of-town travel to/from Toronto on a weekly basis 😁. What can I say…I was able to cut one overnight stay by asking for afternoon pre-infusion blood/clinic appointments. I have discovered that the wait time for the Dr in the afternoon is a lot shorter than the morning appointments. However, this means I drive to Toronto, check in at the Lodge, hop on the shuttle to hospital, get my blood, see Dr, pick up meds and then hop back on shuttle to the Lodge. Early the next morning, I check out of the Lodge and head to hospital for overnight stay.

The team has been very accommodating in meeting my out-of-town travel needs and have worked with me to get things sorted out. I now just need to get the Dr to show up earlier on discharge day so I can get back on the road for my 3-hour drive home as early as possible.

In addition to working out the logistics of travel, there is the health component to be considered. I do not eat, drink, sleep well when I am in travel mode. This has resulted in blood draw issues (even with a port), it can affect my blood counts, and I am not quite as patient because I am tired.

PMH BLOOD/ECG LAB / PMH PHARMACY / PMH TRIAL PHARMACY

In addition to all of this, I am going to post about the process for PMH blood/ECG lab, PMH Pharmacy, and PMH trial pharmacy in my next post. You will encounter at least one of these during each visit. Hope the information is helpful. 

PMH BLOOD/ECG LAB 

If you have a chest port, PICC line or need an ECG, you can get your wait ticket at the kiosk to the left of reception. There is still wait time but it cuts out the wait line to check in at reception. The nurses for port and PICC blood draws usually start at 7:30 and finish their days around 3:30/4:00. For ECG, I only had one morning where the wait was ridiculously long. Apparently, this was due to the fact that the ECG techs had to do portable ECG rounds in the hospital first thing that morning. 

PMH PHARMACY

More waiting!

This pharmacy is open from 9:00 am to 5:30 pm.

The Dr places your med order when she has checked you out and approves treatment.

Note that regular pharmacy orders can be sent to the pharmacy of your choice. I have had on-trial post-med changes that were sent to a pharmacy near the Lodge because I had to start taking them that evening and did not have time to get back to PMH pharmacy to pick them up. However, the timing of when you need to start taking the meds will determine which pharmacy would be best for your situation. Can they fill the order same day? Does the pharmacy have the drugs you need? I ran into a situation where a Shopper's Drug Mart did not have one of the meds available when I went to pick them up. I stressed the urgency that I needed to start taking them immediately. I only needed a couple of pills and they somehow managed to find them for me! 

You have a couple of options to get your PMH prescription order started

1) Go to PMH pharmacy, get your wait ticket from the kiosk (the kiosk has two options - Dr placed order or pick up), wait, see the staff to get your order in the queue and get a pick up time

or

2) Following your Dr appointment, call pharmacy to get your order started and get a pick up time. It may take a couple of calls to get someone on the phone. 

Note that pick up times are never less than 1 hour.

When you get your pick-up time in person, you will either get your ticket back with the time on it or they will ask you to pull another ticket from the kiosk. Getting your ticket back with a time can be a somewhat shorter wait. However, you have to wait for an open staff member and essentially butt in between patients they are calling. I don't let it bother me too much because I know it is also happening while I am waiting in the queue…it is what it is 😁.

If you called the pharmacy to get your prescription started and get a pick up time, you will get a pick-up ticket from the kiosk when you return to pharmacy for pick up.

Pick-up time…They will get your meds, explain them all to you and take payment. The pharmacy will sometimes provide a printed schedule to help guide you when you get home.

PMH TRIAL PHARMACY (4th floor)

Yes…another pharmacy 😂.

This pharmacy only prepares trial drugs. If you have oral trial drugs for pick up to take home, this is the pharmacy you will go to. The wait is usually around two hours.

Again, the Dr will place your order when she has approved you for treatment.

To get your pick-up time, go to the trial pharmacy on the 4th floor after your Dr appointment and use the phone outside of the pharmacy to ask when your drugs will be ready for pick up.

Return to the pharmacy around pick up time. They will bring them out to you. If it seems to be taking longer than projected, use the phone to see how much longer your wait will be.

Note that trials will ask you to return the prescription bottles, so don't toss them…return them to your team at your next appointment.

I would usually go to trial pharmacy to get my pick up time, then head downstairs and pull a ticket at main floor pharmacy and just let things ride. By the time I'm done ordering my drugs in regular pharmacy my trial drugs are ready. I pick those up and go back down and wait for my regular pharmacy pick up. There is a Tim's, Starbucks and Pintos food in PMH. There are other eateries at nearby hospitals (Toronto General, Sick Kids, Mt Sinai)…I'm not sure which eateries but you can ask your team if they know. 

I am rarely without book in hand on these days!

For you adventurous souls…Yonge Street is about a 10-minute walk from the hospital. Winners at College/Yonge and Eaton Centre at Dundas/Yonge 😉. Not a bad way to spend your wait time as long as you make it back before they close 😂.

Full disclosure…I have spent a few 7-hour days going through every step of the patient process from blood work to ECG to Dr to trial pharmacy to pharmacy! Exhausting! There has got to be a better way…there is but they won't listen to me😂😂😂 .

In addition…wait times in all these areas are often longer following a holiday because they are trying to catch up!! Go figure 😵‍💫.

There really is no easy way to navigate all these wait times. Patience is your friend!

@GloHo Thank you for the detail description. Quite involved and I am just getting dizzy from the description. I am at PMH as well, and Pharmacy wait time (just the normal one) drive me crazy - it is always the same meds …..
I really think you are a trooper and self-advocating is the way to go! Good for you! Do you know what kind of drug - mechanism?- you are getting? When do they check for tumor response?

@Tanja

Hi there. Thanks. I've been doing this for a couple of years now and, as you can tell, it still drives me crazy 🤣🤣.

Here's a blurb I found about ARC101:

ARC101 is a bispecific antibody that targets CLDN6 on tumor cells with high specificity and selectivity, and CD3 on T cells. In pre-clinical models, ARC101 demonstrated potent cytolytic activity at low concentrations against a panel of CLDN6-expressing tumor cells in vitro and an ovarian cancer xenograft in vivo.

I am in the first in-human trial for this drug. I do not have CLDN6 or CLDN3, unless they are present in tumour tissue that wasn't tested? I do have CLDN4…but it is clear in the research I've done that ARC101 really just targets 6/3.

It was the last "ovarian-specific" trial available to me so I thought I'd give it a try before I head to the world of phase 1 trials that throw a drug at a lot of different cancers to see what works. All successful drugs started in Phase 1 trials and you never know which one may come out on top 🤞. At the very least, my participation may help determine the viability of a drug for others.

I will have a CT at 8 weeks from trial start…so I should see an appointment pop up around the end of September.

I'm just trying to get into the groove for this trial schedule. Cycle 1 is the worst part of it with the mandatory hospital overnights for three weeks in a row. Next week is my last one!!

-------------------------------------------

@GloHo Thanks for explaining. You just have to keep alive to help all of us navigating through this when times come. 😁😁😁Anti-Cld4 may still work. What I read is that e.g. immune checkpoint inhibitor work even in patients with low PDL-1. So, one never knows.
I will be thinking of you and wish that it works.
Sent from my iPhone

@Tanja

🤣 That's my plan!!

I just want to say again how much I appreciate your understanding of the science behind all this stuff and then putting it into terms I can understand and how it may relate to me. I know I am also low PDL-1 from a previous immunotherapy trial. 

Yes…it is my hope that it may work anyway🤞. 

Thanks for your continued support and guidance. 

-------------------------------------------

@GloHo thank you for this very detailed information. I too am quite familiar with it as a PMH patient. The trials element was new to me. Good information to know.

I have found that calling the PMH pharmacy right after my appointment the best route. In fact, they were the ones to remind me it's the quickest route to getting the meds moving along. Agreed, you still need to get the ticket and wait to pick it up however, I've found it to be less onerous.

FREE DELIVERY - PMH PHARMACY

As well, IF and only IF you are able e.g., you don't need the drug right away OR you are getting a refill, they have a free delivery service. I have used it many times as I live 3+ hours from PMH and I can only get my Lynparza (Olaparib) via PMH pharmacy. You can call them 10 days prior to when you run out and they will deliver it to you. You must give them a minimum of 3 business days (so you can't include weekends in your count of days). I live in a very rural area and have had the meds delivered numerous times. They do tell you, you MUST be home or someone must be home to sign for the medication. This service is a godsend!!!

PMH BLOOD LAB - YOU CAN GO EARLY

One other thing to add to the blood lab. This was advise given to us by a friend who had taken his brother to PMH for treatment. Even though your scheduled appointment time may be 'noon', you can actually show up early e.g., 10am. I found this very liberating as sometimes I got there early and could get the bloodwork out of the way. This is for the blood lab only. I'm not speaking for the chest port, PICC line or ECG area.

ANOTHER PHARMACY

Also to add to your pharmacy list, we have often used the Rexall at Mt Sinai hospital. When I needed my meds during my chemo infusions e.g., olanzapine, we had the oncologist send the script to this location. It's next door to PMH and their turn around time was so much quicker than the PMH pharmacy. Just another option for folks.

I do agree overall however, pack your patience. These pharmacies and everyone working in them are doing an amazing job of trying to service so many needs. I've watched them while waiting and they are so very good with patients and answering questions. I can't imagine how overwhelmed they must be on a daily basis!

#Clinicaltrialsandresearch #Healthandwellness #Treatmentandsideeffects

-------------------------------------------

@Alwayslearning

Thanks for the add ons!

I forgot to mention about arriving early because that is my constant modus operandi. True for port, PICC, ECG, even CTs 😁. I've even shown up for blood the day before my scheduled blood appointment because it takes two days to get the CA125 result and if I'm at a critical point in my trial, I want that result available when I meet with Dr.

Re your Olaparib…when I was on Zejula (Niraparib), Bayshore HealthCare delivered it to my local pharmacy here in town. 

@GloHo I figure the more people know, right?! I was so thankful for the tips & tricks info at PMH. 
I never thought about getting the bloodwork the day before. I, like you, hate that my CA-125 result comes 24 hours after I see the oncologist. I kinda want that at the appointment. 
#Clinicaltrialsandresearch#Treatmentandsideeffects

-------------------------------------------

@Tanja

Hi. Thanks for the link! Unfortunately, I am now only eligible for Phase 1 trials. I have had so many treatments and different types of drugs that I am excluded from most trials beyond first-in-human 😁. 

-------------------------------------------

Thanks for posting @Tanja

#Clinicaltrialsandresearch

-------------------------------------------

@Alwayslearning

I can't ant figure out why I can get my CA125 same day before I leave my Drs appointment in London but it takes a day at PMH 🤔. 

-------------------------------------------

@GloHo well that is strange indeed. I know that when I've had my CA-125 done in Florida, that it's taken 2 days to get the results so I figured 24 hours @PMH was an improvement. I'm going to ask the question when I'm back at PMH for the my next appointment in early September. I'm curious. 

-------------------------------------------

@GloHo what an amazingly detailed account. Thank you so much for sharing. You are such a warrior!!! You are also an A+ student for us to learn from relative to advocating for yourself relative to drugs that work/don't work AND using the tools we have at our disposal e.g., Senokot and prune juice, when needed. I hate that you have the travel element however I know you appreciate the Lodge (thank goodness that opened again). 

I'm guessing based on the 21 day schedule, and days 8 and 15 that you will have to return to PMH for those? I wasn't sure. I know one time my oncologist let me do my labs at LifeLabs as I too live over 3 hours from PMH. I do know however that you are in a completely different scenario since it's a trial, so they may be insistent that you go to PMH.

I do have one question and it's only because of my ignorance relative to trials. Do you know for a fact that you are receiving the 'drug' being tested OR could you be getting a placebo? I wasn't sure if all trials run that way e.g., some get placebo OR if for some you definitely are getting the drug in question.  

Thank you as always for keeping us so informed. I do hope you continue to do well on this one. 🤞🤞🤞

#Clinicaltrialsandresearch

-------------------------------------------

@Alwayslearning

I will have to go to Toronto on Days 8 & 15 because the blood collection is for the trial…they provide specific vials to fill. The good thing is that I have started taking the GO on these single-day visits. It doesn't make the travel day any shorter overall but I don't have to drive into the Toronto mess. I am from Toronto so the traffic is not surprising to me and my aggressive driving is a constant when I'm there 😁. I am finding I enjoy not having to navigate the traffic every time I visit. And, yes, totally grateful for the Lodge! 

Out of the five trials I have participated in, I only had one trial where a placebo was part of the trial and I knew before trial started that I was not in that arm…that I was actually in the doublet drug arm they were testing. I generally don't apply to placebo trials…and I have told my oncologist that if I did end up with a placebo that I would withdraw from the trial. I don't have that kind of time to waste!! 😁 It is up to the patient whether to continue or not. I am actually finding that I am not seeing as many placebo trials…there seem to be more targeted trials…at least in the trials I am now eligible for. I would not outright turn down a promising trial because there is a placebo component…I would go through the motions and hope to get placed in the active drug arm. If not, I'm out. I'm not sure why I was privy to knowing which arm I was in…perhaps because my oncologist was the lead for it?

@GloHo I love the GO train. Agreed it doesn't necessarily save time but it saves grey hairs 😂

Thank you for the trials/placebos explanation. I was with a friend with a medical background who was very insistent that all trials were placebo based. I said,  I don't think so. Glad I was right 😁 To your point it wouldn't make sense not to be in a target trial considering the person's situation. 

#Clinicaltrialsandresearch

-------------------------------------------