Reading the details and trying to puzzle together what is also written between the lines:
- The trial overall is looking for "Enrollment (Estimated) 32 " across dose escalation and dose expansion cohorts.
- Company presentations mention 3 different dosage levels (50, 150 & 450).
- We have been told that the dose expansion part has completed on 24 October 2024.
- Same announcement now mentions that the frontline dose expansion part will open soon, looking to enrol 20 patients.
- The latest presentation did not tick the Frontline part in the 2024 Deliverables.
- The Ash publication in November 2023 mentioned the following trial design, "Trial design: The dose escalation phase will enroll a maximum of 12 patients at 2 dose levels to establish a recommended phase 2 dose (RP2D) using a BOIN design. The dose expansion will enroll up to 20 patients at the RP2D ( Fig. 1)."
From the above, I'm drawing the following conclusions:
- We have already enrolled at least 8 patients (presentation I posted mentions 3/3 & 5/5), but likely even more patients (up to 12).
- The recruitment of these 3 (dose escalation) cohorts is due to be released soon since enrolment completed end of Octover 2024.
- Since Frontline has not been ticked, is the final cohort of the trial and there was no chance to see 20 patients enrolled in that cohort between 24/10/24 and 31/12/24, it must related to the first patient dosed in that final cohort.
- The first part of the trial is not specific to elderly and/or unfit and newly diagnosed, since the trial design on clinicaltrials.gov has a few extra criteria for the dose expansion cohorts (only, not for the escalation cohort), "Dose expansion cohort: Dose expansion cohort will only enroll older/unfit patients with newly diagnosed adverse or intermediate risk AML or MDS/AML who are ineligible for intensive chemotherapy and/or are ineligible for or decline to receive allo-SCT (please refer to stratification in statistics section). [...]"
There is plenty of potential here in the data of the first up to 12 patients already and we should soon find out if my assumptions are correct.
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