Recruiting nowPhase 1
What this trial is trying to do
The researchers are testing PeptiCRAd-1, a peptide-coated virus designed to replicate conditionally in cancer cells, alone and with cyclophosphamide and the checkpoint inhibitor pembrolizumab. They want to explore whether this treatment can stimulate an immune response against the tumour and to examine how it works immunologically.
The idea is that combining a tumour-targeting virus with pembrolizumab, which releases a brake on immune cells, could produce anti-tumour activity that these treatments might not produce alone. At this stage, the trial is mainly measuring safety and tolerability, rather than whether patients live longer or go longer before the cancer grows.
Worth knowing: This is a small, non-randomised phase 1 trial of 15 people, so it is designed chiefly to assess safety and has no comparison group.
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 | NCT05492682 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 1 |
| Design | not randomised, open label |
| Taking part | 15 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | Valo Therapeutics Oy |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug PeptiCRAd-1
- Drug Cyclophosphamide
- Drug Pembrolizumab
What it is measuring
Measurement of Safety and tolerability indexes (Incidence of TEAEs, SAEs and DLTs as assessed by CTCAE version 5.0 and changes in assessed safety parameters) for PeptiCRAd-1 monotherapy.
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 study is being conducted to explore the immunological mechanism of action of Peptide-coated Conditionally Replicating Adenovirus-1 (PeptiCRAd-1) plus Checkpoint inhibitor (CPI) therapy in multiple cancer types, as well as to obtain early information on the safety of this combination therapy.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Metastatic
- Locally advanced
- Not yet treated
- Already treated
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. Written informed consent.
2. Male or female, ≥18 years of age.
3. Patients with any 1 of the following histologically confirmed tumors and who qualifies for new or continued CPI therapy and relapsing to/after standard therapy or the patient has refused or does not tolerate standard therapy:
- Inoperable/metastatic cutaneous malignant melanoma
- Relapsed or newly diagnosed locally advanced inoperable/metastatic TNBC
- Inoperable advanced/metastatic non-squamous NSCLC
- Inoperable and/or advanced Synovial or myxoid round cell sarcoma
- Inoperable and/or advanced osteosarcoma
- Inoperable and/or advanced colorectal cancer, patients assessed as positive for NY-ESO-1 or MAGE-A3 expression at baseline
- Inoperable and/or advanced/metastatic sarcoma, patients assessed as positive for NY-ESO-1 or MAGE-A3 expression at baseline
4. Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
5. Tumor lesion which is deemed feasible for biopsy and injection
6. ECOG/WHO performance status 0 to 1.
7. Acceptable liver and renal function, defined as:
- Total bilirubin ≤1.5 x upper limit of normal (ULN; does not include patients with Gilbert's Disease), and
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0 x ULN, and
- Serum creatinine ≤1.5 x ULN
8.
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 7 sites. Listed in: Germany, Italy.
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 NCT05492682, registered by Valo Therapeutics Oy 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.