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Combination trials usually keep one drug at full dose and push the other as high as patients can bear. Testing a grid of dose pairs would find combinations that work at lower, safer doses.
Project Optimus asks for dose optimisation of single agents; combinations remain largely dosed by escalating the new agent onto a fixed backbone. Model-based combination designs (BOIN-COMB, Bayesian optimal interval for drug combinations, and exposure-response modelling) can explore a two-dimensional dose grid and pick the pair with the best benefit-to-toxicity ratio. The proposal is regulatory expectation that registrational combination trials justify both doses with such data.
Shares Too many combinations to test, Wrong doses, Immune checkpoint inhibitors.
Shares Wrong doses, Antibody-drug conjugate (ADC), Immune checkpoint inhibitors.
Shares Wrong doses, Antibody-drug conjugate (ADC).
Shares Wrong doses, Antibody-drug conjugate (ADC).
Shares Wrong doses, Immune checkpoint inhibitors.
Shares Too many combinations to test, Immune checkpoint inhibitors.
Shares Too many combinations to test, Immune checkpoint inhibitors.
Shares Wrong doses, Antibody-drug conjugate (ADC).