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The first time a new drug is given to people, after animal and laboratory testing and clearance of an Investigational New Drug application. In oncology these are phase 1 trials in patients with advanced cancer who have exhausted standard options, starting at a fraction of the dose predicted to be safe; modern designs run straight through to registrational cohorts.
An Investigational New Drug application (or EU clinical trial authorisation) summarising toxicology, manufacturing and the protocol must be cleared before dosing. Starting doses derive from animal no-adverse-effect levels or, for immune agonists after the TGN1412 disaster, from minimal anticipated biological effect levels. First-in-class drugs (a new mechanism) carry more uncertainty than follow-on agents. Modern FIH trials are seamless: escalation, expansion and sometimes registrational cohorts in one protocol, so a first-in-human study can lead directly to accelerated approval (sotorasib, tarlatamab). 'Entering the clinic' marks a programme's transition from preclinical to clinical stage.
Shares Ethics review (IRB, research ethics committee), Informed consent, Seamless, adaptive and Bayesian trial designs, Phase 1, 2 and 3 trials.
Shares Dose-escalation designs (3+3, BOIN, dose-expansion), Seamless, adaptive and Bayesian trial designs, Phase 1, 2 and 3 trials.
Shares Ethics review (IRB, research ethics committee), Trial lifecycle: from protocol to label, Seamless, adaptive and Bayesian trial designs, Phase 1, 2 and 3 trials.
Shares Maximum tolerated dose (MTD), Dose-escalation designs (3+3, BOIN, dose-expansion).
Shares Maximum tolerated dose (MTD), Dose-escalation designs (3+3, BOIN, dose-expansion).
Shares Ethics review (IRB, research ethics committee), Trial lifecycle: from protocol to label, Phase 1, 2 and 3 trials.
Shares Informed consent, Seamless, adaptive and Bayesian trial designs, Phase 1, 2 and 3 trials.
Shares Dose-escalation designs (3+3, BOIN, dose-expansion), Seamless, adaptive and Bayesian trial designs, Phase 1, 2 and 3 trials.