Clinical trial · Interventional
Autologous Tumour Vaccine Trial
A Phase I Trial of Autologous Tumour Vaccine for Advanced Solid Cancers
NCT05807035CI-TRIAL-00095282recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Phase 1 trial to evaluate the feasibility of preparation, safety, tolerability and response to a personalised autologous tumour vaccine (ATV) formulated with Advax adjuvant when administered to patients with advanced solid cancers either as monotherapy or in combination with other standard of care agents
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radvax | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Radvax
- description
- This is a single arm study where all participants will get active Radvax autologous tumour vaccine weekly for 4 weeks and then monthly thereafter
- interventionNames
- Biological: Radvax
Primary outcomes (1)
- measure
- Incidence of grade 3 or 4 adverse effects
- timeFrame
- Interval from time of vaccination to 7 days post vaccination
- description
- Incidence of grade 3 or 4 adverse effects related to vaccine administration
Secondary outcomes (3)
- measure
- Progression free survival
- timeFrame
- From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Subjects must have histologically or cytologically confirmed advanced solid cancers or hematological cancers (lymphomas only) * Subjects must have received at least one prior therapy for this disease, with the exception that subjects for whom no standard therapy options exist or who decline standard therapies can be considered for inclusion after discussions with the investigator team. * Performance status ≤ 2 (ECOG performance status) * Subjects or their parents if a child must have the ability to understand and the willingness to sign a written informed consent document. * If no suitable cancer tissue is already available to make the vaccine, to be enrolled in the trial participants must be willing to undergo surgery and/or fresh tumour biopsy to obtain tissue to allow the preparation of the vaccine and their primary care team needs to have agreed to perform these procedures for them to obtain tumour tissue. The trial team will provide advice on appropriate tissue collection and arrange transport and processing but are not responsible for arranging such surgery or paying for its cost. Exclusion Criteria: * Subjects receiving any other investigational agents within the preceding 4 weeks. * Pregnant women because of the unknown risk of adverse events in the foetus secondary to treatment of the mother with ATV. * Any potential participant where suitable cancer tissue is not available for preparation of the vaccine * Any condition that the Investigator deems may make a potential participant unsuitable for entry into the trial.
References
Publications (0)
Data not yet available
No reference posted for this study.