Anyone familiar with the clinical trial RMC-6236? Or how to enroll?

Posted by amchurch @amchurch, Mar 21, 2024

Question,,,is anyone familiar with the clinical trial for RMC-6236? Or is currently enrolled in it? Or is familiar with how the process works?

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I did the combo trial, 9805 with 6236. It had immediate effects and for nsclc it is having wonderful results based on a thread I am in for these drugs. The side effects of 6236 are also immediate. Scalp sores/scabs, face breakout, nail bed infections, and mouth sores.

I did not have any progression for 6 months. The progression I did have was in a watched area and a small nodule in my lung.

If they can get a handle on the severe skin problems and couple it with the right dosage and type of chemo, I believe it will be a stabilizer .

Many come off of it because of the severe skin issues. Hope this helps. I was in phase 1b. If you are doing this trial, proactively ask for skin remedies besides doxycycline.

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@gamaryanne

I did the combo trial, 9805 with 6236. It had immediate effects and for nsclc it is having wonderful results based on a thread I am in for these drugs. The side effects of 6236 are also immediate. Scalp sores/scabs, face breakout, nail bed infections, and mouth sores.

I did not have any progression for 6 months. The progression I did have was in a watched area and a small nodule in my lung.

If they can get a handle on the severe skin problems and couple it with the right dosage and type of chemo, I believe it will be a stabilizer .

Many come off of it because of the severe skin issues. Hope this helps. I was in phase 1b. If you are doing this trial, proactively ask for skin remedies besides doxycycline.

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Hi. I’m looking into this trial as an option. Did you leave the trial because of the side effect or the drug became ineffective? Thank you so much.
Sandy

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I did both RM 9805 and 6236 for 7 months. Can discuss side effects, etc if anyone is interested.

Phase 3 trial in progress now couples 6236 with standards of care.

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@gamaryanne

I did both RM 9805 and 6236 for 7 months. Can discuss side effects, etc if anyone is interested.

Phase 3 trial in progress now couples 6236 with standards of care.

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I would be interested in your experience with the RMC-6236 clinical trial.
Thank you
Sandy

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@gamaryanne

I did both RM 9805 and 6236 for 7 months. Can discuss side effects, etc if anyone is interested.

Phase 3 trial in progress now couples 6236 with standards of care.

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I would be interested in hearing as well. Both trials.

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@gamaryanne

I did both RM 9805 and 6236 for 7 months. Can discuss side effects, etc if anyone is interested.

Phase 3 trial in progress now couples 6236 with standards of care.

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Would you still be willing to discuss your experience with 9805 and 6236? Where did you receive your clinical trial?
Thank you and have a blessed day 🙂
Sandy

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@sandyk62

Would you still be willing to discuss your experience with 9805 and 6236? Where did you receive your clinical trial?
Thank you and have a blessed day 🙂
Sandy

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@sandyk62
Of course. I would be happy to share my experience.
I chose to do it in Huntersville, NC. I entered in a phase 1b study. It’s now in phase 3
Feel free to private message me and I can give you my phone number. We can do a zoom or phone chat!

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@stageivsurvivor

Yes, I am very familiar with this trial. RMC-6236 is a unique drug compound designed to be a “pan”-KRAS targeted therapy meaning it is potentially capable to target several of the KRAS variants-not just a single one.

Here is the link to the trial descriptor, all the sites currently recruiting and the contact phone and e-mail of the trial sponsor. Look for a site near you that indicates recruitment is open. Do a Google search of the institution and for the link to clinical trials. Once in that section of the facilities’ website where all trials are listed, search for RMC-6236. It will give you the contact info for the principal investigator (P.I.) and the clinical trial nurse coordinator. If you have difficulty finding this information, contact the Pancreatic Cancer Action Network (PanCan.org) at 877.272.6226, M-F, 7:00am-5:00pm PT. Speak to a case manager who can look up contact info for the RMC-6236 clinical trial.

There is a lot of interest in this trial because 90% of pancreatic cancers are linked to a KRAS somatic mutation. That means each site likely will meet their accrual quota quickly. I suggest you obtain your complete medical records and follow through quickly if you are interested in participating in this clinical trial. They key pieces of information a P.I. will need to determine eligibility are: Cellular Pathology report confirming specific diagnosis, a surgical pathology report if surgery was performed, Radiologist interpretations of current and prior imaging (CT or MRI), copies on CD or the imaging, current blood chemistry and hematology reports. Chemotherapy log detailed administration of each chemo cycles, drugs used and concentrations. Most of this will be available on your patient portal and can be downloaded and sent as a pdf file. If you were not requesting copies of your imaging at the time they were done, then you will need to contact the medical records department to obtain them. The chemo administration log likely will not be in the patient portal. Contact your N.P. who can obtain that file which is usually in the form of an Excel spread sheet.

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Do you have any further updates and/or opinions on these drugs now that it is in Phase 3? Very much appreciated.
Sandy

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RM 6236 has quite some side effects related to the skin. Scalp sores, face blisters, and nail bed sores. These are ongoing. If one goes in this trial, be sure to ask for possible preventatives and treatments. These issues coupled with chemo side effects could be difficult to manage. I hope the trial coordinator has come up with something more than doxycycline by now. That is all they had for me in the phase 1b trial.

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@sandyk62

Do you have any further updates and/or opinions on these drugs now that it is in Phase 3? Very much appreciated.
Sandy

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I was recently at the AWCR and ECOG-ACRIN oncology meetings and the reports on the phase II trial were very favorable. The RASolute 302 trial is underway in multiple sites including international sites and this drug is expected to receive expedited review when the study is complete for approval.

The management of RAS-related side effects with RMC-6236 appears to mirror the approach used for patients treated with EGFR inhibitors for metastatic colorectal cancer. This involves
antibiotic started as a preventive measure, typically cycling twice a day.

To address risk, topical steroids
and topical antibiotics are being used. Additionally, the study data indicates that dose modifications (interruptions or reductions) were used to manage side effects in some patients. Rash was the most common reason for dose reduction. Importantly, very few patients discontinued treatment due to Treatment Related Adverse Events (TRAEs) in the Phase 1 study.

Implications for Phase III:

It's likely that the experience from the Phase 1 trial, including the observed side effects and successful management strategies, will inform how side effects are monitored and managed in the ongoing Phase III RASolute 302 trial. The focus will likely remain on proactive management of common side effects like rash and gastrointestinal issues using similar supportive measures and dose adjustments as needed.

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