Inclusion and Exclusion Criteria in Tigilanol Tiglate Trials: How EBC-46 Patient Cohorts Are Defined
Inclusion and exclusion criteria are the gatekeepers of every clinical trial. Here is how they have been used to shape patient selection in tigilanol tiglate (EBC-46) studies.
Every clinical trial is, in part, an exercise in scoping. Investigators must decide which patients are eligible to enrol and which must be excluded — not because their cases are uninteresting, but because including them would either expose them to unacceptable risk or blur the trial’s scientific signal. For tigilanol tiglate, the diacylglycerol-mimic small molecule originally derived from the seeds of Fontainea picrosperma, the published trials register on the ClinicalTrials.gov database gives a useful window into how patient cohorts have been defined.
The dual purpose of selection criteria
Inclusion criteria define the population the trial intends to learn about: tumour type, stage, prior treatment status, anatomical accessibility for intratumoural injection, performance status, and laboratory thresholds for organ function. Exclusion criteria carve out subgroups that are either at heightened risk of adverse events or likely to confound interpretation: pregnancy, severe immunosuppression, recent investigational therapy, uncontrolled co-morbidities, or specific contraindications to the planned procedural delivery.
For tigilanol tiglate — administered intratumourally as a single-dose local treatment in oncology trials — the procedural dimension is unusually prominent. The drug must be physically delivered into a measurable, accessible solid tumour. That requirement alone shapes the inclusion list: tumours must be of an appropriate size range, anatomically reachable, and sufficiently demarcated for accurate injection.
Typical inclusion criteria seen in EBC-46 trials
Across QBiotics-sponsored Phase I and II programmes, the inclusion criteria have generally featured: histologically confirmed solid tumour of an eligible type, at least one measurable target lesion accessible for injection, ECOG performance status of 0–1 or sometimes 0–2, adequate organ function (liver, renal, haematological), and capacity to provide informed consent. We covered related design considerations in our piece on sample size and statistical power and on tumour-type stratification.
Adequate organ function thresholds typically include neutrophil counts above a defined floor, platelet counts above 75–90 × 10⁹/L, haemoglobin above a defined level, alanine aminotransferase and aspartate aminotransferase below 2.5× the institutional upper limit of normal (or 5× in the presence of liver metastases), and serum creatinine within an acceptable range. These thresholds protect against compounded toxicities and align with ICH-E6 Good Clinical Practice expectations.
Common exclusion criteria
Exclusions in tigilanol tiglate studies have generally captured: pregnant or breastfeeding patients, untreated central nervous system metastases, uncontrolled infection, recent major surgery, recent investigational therapy, known hypersensitivity to excipients in the formulation, and clinically significant cardiovascular disease (recent myocardial infarction, uncontrolled arrhythmia, severe heart failure). For procedural reasons, lesions overlying critical anatomy — large vessels, airways, joints — are also typically excluded.
Concurrent anticoagulation is another common consideration. Because tigilanol tiglate produces a localised inflammatory and necrotic response at the injection site, patients on systemic anticoagulants may be required to pause therapy for a defined washout, or be excluded if pausing is clinically inadvisable. The injection-site biology is described in summary form in QBiotics’ corporate programme overview.
Why these criteria matter for interpreting results
When safety and efficacy results are reported, the inclusion and exclusion criteria define the population to which those results apply. A trial that excluded patients with uncontrolled diabetes, recent infection, and ECOG 2 cannot speak directly to outcomes in those subgroups; the data have to be extrapolated cautiously, if at all. This is a general feature of oncology trials, not specific to EBC-46, but it shapes how regulatory bodies and clinicians read the published literature.
Readers tracking the EBC-46 evidence base should pay particular attention to which exclusions softened over time as more safety data accumulated, and which remained in place into Phase II/III protocols. Persistent exclusions — e.g. of pregnancy or active untreated CNS disease — reflect the floor of clinical caution; loosened exclusions reflect growing confidence in the agent’s safety envelope.
Distinct from supplement use
It is worth restating that the trial population for pharmaceutical-grade tigilanol tiglate is fundamentally different from the consumer audience for blushwood berry dietary supplements. The trials enrol carefully selected oncology patients receiving intratumoural injections; consumer supplements such as those sold by Blushwood Health are food products taken orally, with no therapeutic claims. The two populations and use cases are not interchangeable, and inclusion-exclusion criteria do not translate from one context to the other.
Related articles
See also our overview of QBiotics Phase I/II human trials and our explainer on reading EBC-46 trial readouts.
Sources
1. ClinicalTrials.gov — NIH database of clinical studies, 2026.
2. ICH — Efficacy Guidelines (Good Clinical Practice), 2026.
3. QBiotics Group — Tigilanol Tiglate Programme, 2026.
4. Blushwood Health, 2026.
