OnCo
ideasIdea

Sequential multiple-assignment randomised trials to find the best order of ADCs

Patients are randomised at each decision point, not just at the start, so one trial can compare whole treatment sequences rather than single drugs.

SMART designs, standard in behavioural science, randomise patients again at progression. In metastatic breast cancer where three ADCs (T-DXd, sacituzumab, Dato-DXd) and multiple payload classes compete, a SMART would compare sequences (A then B versus B then A, payload switch versus antigen switch) with a primary endpoint of time to failure of the second line or overall survival.

Hypothesis
A SMART in HER2-low metastatic breast cancer identifies a sequence with at least four months longer overall survival than the most common real-world sequence.
Rationale
Sequences are almost never randomised, so guidelines are built from single-line trials with different populations. Cross-resistance among topoisomerase-1 payload ADCs makes order a plausibly large effect.
What would test it
A cooperative-group SMART with two re-randomisation points, 600 patients, embedding SLFN11 and TOP1 biomarker sampling at each progression.
Maturity
speculative
Who has to act
research
Cost to try
Large (over $50M)
Years to first evidence
5
Bottlenecks it attacks

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