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When two cancer drugs are combined, each is usually given at its full single-agent dose, which often proves too toxic. Testing a grid of dose pairs would find combinations that work with tolerable side effects.
Combination phase 1/2 studies use model-based two-agent dose-finding (partial-order CRM, BOIN-COMB) or factorial randomised designs to explore dose pairs, with efficacy and tolerability read-outs at each pair, rather than fixing one agent at its label dose and escalating the other. Regulators expect a justification for each agent's dose in combination labels.
Shares Wrong doses, Small-molecule kinase inhibitors, Immune checkpoint inhibitors.
Shares Too many combinations to test, Wrong doses.
Shares Wrong doses, Small-molecule kinase inhibitors, Immune checkpoint inhibitors.
Shares Too many combinations to test, Wrong doses, Immune checkpoint inhibitors.