As many of you know, I am a big fan of the strategy employed by the experimental drug MGD007. It physically drags immune T-cells into close proximity to cancer cells displaying the gpA33 marker. About 95% of CRC (including CRC stem cells) are gpA33+. It is a brute force type of immunotherapy but unfortunately CRC has not responded to more subtle forms of immunotherapy (yet).
My main concern revolves around toxicity. Normal GI cells also display gpA33 – which could likely cause some GI-toxicity or colitis. A second part of my concern is like any strong immunotherapy, there is a chance of cytokine release syndrome (CRS) which can be very serious. https://en.wikipedia.org/wiki/Cytokine_release_syndrome
Related to this, our own Belle was patient #1 on this trial and she experienced very bad toxicity (GI and potentially CRS as well). I have been told that of the 6 patients in dose cohort #1, only 1/6 patients developed such major tox (Belle). They are now dosing the next higher dose level. Until more patients get dosed, we can’t know if Belle was an extreme outlier in terms of tox or not – hopefully at least some of the next round of patients will blog their experiences on CC – both in terms of efficacy and tox.
The GI toxicity Belle had “may” have been an indirect measure that the drug was attacking her tumors as well? Sort of like the cetuximab rash/tumor efficacy correlation since in both cases, tox could be due to successfully hitting the target (EGFR+ or gpA33+) in a tissue outside the tumor, implying that the (EGFR+ or gpA33+) tumor is being hit too. For Belle’s tox reasons I remain cautious about this trial until we hear back how the next round of patients does but if I were later Stage IV, it would be in the top tier of trials I would be considering with my MD.
I mostly wanted to post this update today because they have dramatically increased the number of trial sites. This “could” indicate internal optimism that things are looking good. That potentially incorrect conjecture aside, having more sites open will generate data much faster
(good or bad) which is great news for the patient community!
-DKhttps://clinicaltrials.gov/ct2/show/NCT ... 007&rank=1Current expanded sites pasted below:United States, Maryland
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center Recruiting
Baltimore, Maryland, United States, 21205
Contact: Ellen Lilly-Foreman, RN, OCN 443-287-4961 email@example.com
Contact: Thomas Brown 410-502-5328 firstname.lastname@example.org
Principal Investigator: Daniel Laheru, MD United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Margaret Carey 617-632-5575 MargaretM_Carey@DFCI.HARVARD.EDU
Principal Investigator: David P Ryan, MD
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Susan Sheehan, RN 617-724-4000 Ssheehan1@mgh.harvard.edu
Principal Investigator: David P Ryan, MD United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Anthony Amara 919-668-1861 email@example.com
Principal Investigator: Herbert Hurwitz, MD
Carolina Biooncology Institute Recruiting
Huntersville, North Carolina, United States, 28078
Contact: Ashley McClain 704-947-6599 ext 117 firstname.lastname@example.org
Principal Investigator: John Powderly, MD United States, Oregon
Providence Portland Medical Center Recruiting
Portland, Oregon, United States, 97213
Contact: Yue-yun To, RN 503-215-2855 email@example.com
Principal Investigator: Todd Crocenzi, MD