Chimeric Therapeutics Ltd (ASX:CHM) presented the design and objectives of its CHM 1101 Phase 1B clinical trial in progress for patients with glioblastoma multiforme (GBM) on Saturday, June 3 at the American Society of Clinical Oncology (ASCO) Annual Scientific Meeting (ASCO23) in Chicago.
The company’s poster presented at ASCO23 can be viewed here.
The new trial, conducted under a US IND (Investigational New Drug), is a two-part Phase 1B trial in patients with recurrent and/ or progressive glioblastoma designed to assess safety and efficacy and determine a recommended Phase 2 dose and administration schedule.
Chimeric’s new trial will build from the learnings of the Phase 1A dose escalation investigator-initiated trial that has advanced to the 4th and final dose level with no dose limiting toxicities.
75% disease stability achieved
Data previously presented from the Phase 1A trial demonstrated 75% disease stability in the initial two dose cohorts.
Additionally, the ASCO abstract provided background data on one patient who was treated in the initial dose cohort and survived 15.5 months from time of first CHM 1101 infusion.
This patient’s experience is compelling as patients with recurrent/progressive glioblastoma are generally expected to survive only 2-9 months.
Read: Chimeric Therapeutics activates Phase 1B of CHM 1101 glioblastoma clinical trial
Part A of the new trial will enrol 3-6 patients at the 440 X106 CHM 1101 cells as a dose confirmation cohort.
Patients will be administered CHM 1101 across 3 once-weekly (Days 0, 7, and 14) intracranial (intracavitary and intraventricular) infusions.
In late 2023, Chimeric will assess the clinical safety and activity from the CHM 1101 clinical program.
Based on a favourable review of the results of that assessment, Part B of the trial, a dose expansion cohort, will be opened to enrol 12 to 26 additional patients.
Upon successful completion of the Part B dose expansion cohort, Chimeric intends to design and initiate a registration trial, in collaboration with global regulatory feedback.