Human Trials

Human Trials

Bayesian Dose-Escalation Designs in Tigilanol Tiglate Phase I Trials: How EBC-46 Researchers Find a Safe Working Dose

Phase I trials of tigilanol tiglate use Bayesian and modified 3+3 dose-escalation schemes. This article explains how those statistical designs decide the next-cohort dose.

Human Trials

Geographic Distribution of Tigilanol Tiglate (EBC-46) Clinical Trial Sites: Where the Human Research Is Actually Happening

A look at where tigilanol tiglate human clinical trials have been conducted to date and what the geographic footprint tells us about EBC-46 translational research priorities.

Human Trials

Circulating Tumour DNA (ctDNA) as a Pharmacodynamic Biomarker in Tigilanol Tiglate (EBC-46) Clinical Trials

How ctDNA / liquid biopsy is emerging as a dynamic biomarker for monitoring early response, residual disease, and recurrence in tigilanol tiglate (EBC-46) clinical trials.

Human Trials

Combination-Therapy Trial Designs for Tigilanol Tiglate (EBC-46): How Researchers Are Studying Pairings With Other Agents

How clinical researchers structure combination trials pairing tigilanol tiglate with other oncology agents — design considerations, endpoints, and what published work has examined.

Human Trials

Quality-of-Life Endpoints in Tigilanol Tiglate Trials: Measuring What Matters to Patients

How patient-reported outcome instruments are being integrated alongside RECIST and adverse-event reporting in tigilanol tiglate clinical trials, and why they matter for interpreting human data.

Human Trials

Adverse Event Profile in Tigilanol Tiglate Phase 2 Trials: Local Versus Systemic Effects

Published Phase 2 human trial data for intratumoural tigilanol tiglate shows a distinctive safety signature: predominantly local, transient, and rarely systemic.

Human Trials

RECIST Response Criteria in Tigilanol Tiglate Trials: How Tumour Response Is Actually Measured

RECIST 1.1 is the standard framework for measuring tumour response in clinical trials. Here is how it applies — and where it falls short — for intratumoural agents like tigilanol tiglate.

Human Trials

MRI as a Response Biomarker in Tigilanol Tiglate Clinical Trials

Imaging endpoints — particularly contrast-enhanced MRI — have become important in tigilanol tiglate trials. Here is how MRI is being used as a response biomarker.

Human Trials

Pharmacokinetic Monitoring in Tigilanol Tiglate Phase I Trials: EBC-46 Drug Metabolism Considerations

How pharmacokinetic sampling, plasma assays and exposure-response modelling are designed for intratumourally administered EBC-46 / tigilanol tiglate Phase I clinical trials.

Human Trials

Surrogate Endpoints in Tigilanol Tiglate Clinical Trials: Beyond Tumour Response Rate

Why oncology trials of intralesional tigilanol tiglate may benefit from surrogate endpoints — and which biomarkers are plausible candidates for future studies.

Human Trials

Phase III Pivotal Trial Design Considerations for Tigilanol Tiglate (EBC-46): What a Confirmatory Study Would Need

Methodological considerations that would shape a Phase III confirmatory trial for tigilanol tiglate, including endpoints, controls, and patient selection.

Human Trials

Open-Label vs. Randomised Designs in Tigilanol Tiglate Trials: Methodological Trade-Offs

A neutral comparison of open-label and randomised study designs used in the tigilanol tiglate clinical programme, and what each design choice can and cannot demonstrate.