Recruiting nowPhase 1
What this trial is trying to do
The researchers are testing whether injecting IVX037 directly into tumours can be given safely to people with advanced colorectal, ovarian or gastric cancer, either alone or alongside sintilimab, an immune checkpoint inhibitor that helps immune cells attack cancer. The trial is divided into dose-escalation stages to find workable doses and assess how the treatments are tolerated.
The idea is that delivering IVX037 into the tumour, with or without immune stimulation from sintilimab, might provide a useful treatment approach for cancers that are difficult to treat, but this study is measuring feasibility, safety and tolerability rather than whether patients live longer or the cancer grows more slowly.
Worth knowing: This is an early-phase, open-label trial without a comparison group, and the colorectal cancer group is limited to microsatellite-stable (MSS) disease.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
| Registry number | NCT05427487 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 1 |
| Design | not randomised, open label |
| Taking part | 70 people (planned) |
| Who can join | aged 18 Years to 85 Years |
| Run by | ImmVirx Pty Ltd |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Biological IVX037
- Biological Sintilimab
What it is measuring
Phase 1a – feasibility, safety, and tolerability of intratumoral IVX037 when administered to patients with advanced colorectal, ovarian or gastric cancers
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
Phase 1. Tests safety and dose in a small group. Some people do benefit, but that is not what the trial is designed to find out.
How the researchers describe it
This is a Phase 1 open-label, non-randomized, multi-center clinical trial of intratumoral IVX037 as monotherapy and in combination with an immune checkpoint inhibitor in patients with advanced micro satellite-stable (MSS) colorectal cancer, or gastric or ovarian cancer.
The study is run in 2 parts. Phase 1a is dose escalation IVX037 monotherapy and Phase 1b is IVX037 with checkpoint inhibitor, sintilimab.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Metastatic
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
Inclusion Criteria
1. Has either a histologically confirmed advanced colorectal, gastric/gastroesophageal adenocarcinoma, or ovarian cancer that has progressed or is not suitable for standard of care systemic therapies. Participants with colorectal cancer must have either a primary tumor or a biopsy of a metastatic tumor which has been shown to lack microsatellite instability (by PCR) or to have normal expression of mismatch repair enzymes (by immunohistochemistry). That is, a mismatch repair proficient mCRC tumor.
2. Progressed on or after at least one prior line of systemic therapy and must not have had more than 3 prior lines. Phase 1b only: participants with gastroesophageal cancer must have failed prior treatment with an immune checkpoint inhibitor.
3. Has at least one injectable tumor that meets RECIST1.1 criteria to be designated as a target lesion, and is:
1. a liver lesion 1.0 to 6.5 cm (longest diameter) meeting RECIST criteria on baseline CT scan or MRI and suitable for injection under CT or ultrasound guidance, and participant has an estimated total tumor burden of disease < 1/3 of liver volume based on CT or MRI imaging, or
2. A measurable lymph node, i.e., with a short axis diameter (SAD) of 1.5 cm to 6.5 cm, or
3. Other solid tumor with a longitudinal diameter 1.0 cm to 6.5 cm.
4.
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 3 sites. Listed in: Australia.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT05427487, registered by ImmVirx Pty Ltd on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.