TCE-IPDE

Intrapatient dose escalation for first-in-human T-cell engagers

Index of the documents in the TCE-IPDE project: the working specification, its references, reading notes, and the code that draws its figure.

Does escalating dose within a patient reach a confirmable active dose sooner in a first-in-human T-cell engager trial, and does the time it saves outweigh the extra visits and hospital time it costs? The simulation that would answer this has been specified and not built.

Documents

• Working specification. The design, the PK and pharmacodynamic models, the endpoints, and the implementation sequence. Its In brief section is one screen and says what the rest argues.
• References. What to read and in what order, and a marker on every source recording whether the specification’s use of it has been checked.
• MCLA-117 notes. The published Cycle 1 escalation scheme the specification cites as precedent, its dose tables, and the four features of it that bear on the design.
• Simon 1997 reading notes. What the accelerated titration designs paper reports when intrapatient escalation is switched on and off, with every number sourced to a page.

Code

• make_escalation_figure.py draws mcla117-escalation.svg, the Cycle 1 escalation figure in Section 6 of the specification. Plain Python with no plotting library, so the site build never runs it. Run it after changing the dose table it carries.