Background Classical phase 1 dose-finding designs based on a single toxicity endpoint to
assess the maximum tolerated dose were initially developed in the context of cytotoxic …

Background Determining the optimal biological dose (OBD) has been described as an
alternative strategy to the maximum tolerated doses (MTDs) for identifying the recommended …

With the emergence of molecular targeted agents and immunotherapies in anti-cancer
treatment, a concept of optimal biological dose (OBD), accounting for efficacy and toxicity in …

Recent revolution in oncology treatment has witnessed emergence and fast development of
the targeted therapy and immunotherapy. In contrast to traditional cytotoxic agents, these …

Highlights•Recent experience with targeted anticancer drugs and immunotherapies suggest
the traditional approach of using the maximal tolerated dose (MTD) is not ideal.•Project …

One of the key goals of early-phase cancer clinical trials is to determine the best dose of a
drug to take forward into subsequent, outcomes-oriented, clinical trials. Typically, once a …

The purpose of early stage clinical trials is to determine the recommended dose and toxicity
profile of an investigational agent or multi-drug combination. Molecularly targeted agents …

Immuno-oncology (Isingle bondO) and cell therapy, the frontier of cancer treatment, is a
rapidly developing area that brings new opportunities to patients. In Isingle bondO and cell …

One of the key objectives of oncology first-in-human trials has often been to establish the
maximum tolerated dose (MTD). However, targeted therapies might not exhibit dose-limiting …

Phase 1 dose-escalation trials are crucial to drug development by providing a framework to
assess the toxicity of novel agents in a stepwise and monitored fashion. Despite widely …