ReviewClinical trials (London, England)2024
Adaptive phase I-II clinical trial designs identifying optimal biological doses for targeted agents and immunotherapies.
Review in Clinical trials (London, England), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
8 citing papers in PubMed.
- Minor histocompatibility antigen TCR-T.Blood advances · 2026Review
- Dosing, duration, and timing controversies in determining immune checkpoint inhibitor dosing regimens.NPJ precision oncology · 2026Article
- Safety and feasibility of talimogene laherparepvec in peritoneal surface malignancies: Results from the TEMPO trial.Molecular therapy. Oncology · 2026Article
- Harnessing cellular immunotherapy for cholangiocarcinoma: an integrated roadmap for overcoming resistance.Frontiers in immunology · 2026Review
- A randomized Bayesian phase I-II dose optimization design for combination cancer therapies with progression-free survival end point.BMC medical research methodology · 2025Article
- UNITED: A Unified Transparent and Efficient Phase I/II Trial Design for Dose Optimization Accounting for Ordinal Graded, Continuous and Mixed Toxicity and Efficacy Endpoints.Statistics in medicine · 2025Article
- A Bayesian Dynamic Model-Based Adaptive Design for Oncology Dose Optimization in Phase I/II Clinical Trials.Pharmaceutical statisticsArticle
- Great Wall: A Generalized Dose Optimization Design for Drug Combination Trials Maximizing Survival Benefit.Pharmaceutical statisticsArticle
Corrections and comments
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Authors and funding
6 authors.
Funding
Abstract
Targeted agents and immunotherapies have revolutionized cancer treatment, offering promising options for various cancer types. Unlike traditional therapies the principle of "more is better" is not always applicable to these new therapies due to their unique biomedical mechanisms. As a result, various phase I-II clinical trial designs have been proposed to identify the optimal biological dose that maximizes the therapeutic effect of targeted therapies and immunotherapies by jointly monitoring both efficacy and toxicity outcomes. This review article examines several innovative phase I-II clinical trial designs that utilize accumulated efficacy and toxicity outcomes to adaptively determine doses for subsequent patients and identify the optimal biological dose, maximizing the overall therapeutic effect. Specifically, we highlight three categories of phase I-II designs: efficacy-driven, utility-based, and designs incorporating multiple efficacy endpoints. For each design, we review the dose-outcome model, the definition of the optimal biological dose, the dose-finding algorithm, and the software for trial implementation. To illustrate the concepts, we also present two real phase I-II trial examples utilizing the EffTox and ISO designs. Finally, we provide a classification tree to summarize the designs discussed in this article.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.