Individual Patient Expanded Access of CTX-009 for the treatment of metastatic gallbladder cancer

an 80-year-old male with history of pT2N0 adenocarcinoma of the gallbladder s/p segment 4/5 partial hepatectomy with gallbladder resection and portal lymph nodes excision on 7/27/2022, pathology showing moderately differentiated adenocarcinoma fo gallbladder, clear margins and no liver involvement; +LVI, - PNI, 0/5 LN. S/p Adjuvant capecitabine Sept 2022 - March 2023. Imaging with PET scan in March 2023 showed metastatic to pelvic lymph node with peritoneal implants. CT 3/2/23, increasing peritoneal nodules and implants - latest up to 1.6 cm. PET 3/13/23 FDG avid mediastinal and hilar nodes (suspected inflammatory), pelvic nodule in mesentery 1.1 cm with SUV 3. Biopsy of pelvic node done showing metastatic adenocarcinoma 3/24/23. S/p Chemo- gem/cis and durva 4/18/23 - 9/29/23 when imaging showed POD. He enrolled in clinical trial CTX-009-002 (NCT05506943) and was randomized to CTX+taxol - x14 cycles (10/19/23 to10/20/24) and did very well with radiographic CR. He was observed until recent CT scans 6/26/25 showed recurrent disease in pelvic lymph nodes (also, conversion of ctDNA to positive (Signatera)). This recurrence is not amenable to surgery due to proximity to bowel and urologic organs. PS is 0 and he has no residual toxicityd. At this time we wish to restart CTX-009 and paclitaxel.

For further information about clinical trials, please contact us at 732-235-7356.