Clinical Trials

At PsiOxus, we are driven to deliver on the promise of our cancer gene therapy and oncolytic virus products and bring medicines of value to patients with cancer. We are currently advancing development candidates and human clinical trials are in-progress.

Below is a list of clinical trials for which PsiOxus is actively recruiting participants. We have provided links to the study listings on www.clinicaltrials.gov, where you can find more information, including details on eligibility criteria and clinical trial locations.

The FORTITUDE Study

The FORTITUDE Study is a Phase I multicenter, open-label, non randomized first-in-human clinical trial of NG-350A in patients with metastatic or advanced epithelial tumors. The FORTITUDE study is expected to enroll up to 125 patients across multiple clinical study sites. Phase 1a of the study will assess the safety, tolerability and dose of NG-350A and will enroll patients at study sites in the United States, led by MD Anderson Cancer Center. Phase 1b of the study will evaluate NG-350A in expansion cohorts in patients with specific metastatic or advanced tumors.

For more information about this trial and participating centres, please follow these links:

ClinicalTrials.gov                Poster presented at ASCO 2019

The SPICE Study

The SPICE Study (Study of PD-1 Inhibition in Combination with Enadenotucirev) is run by PsiOxus in a clinical trial collaboration with Bristol-Myers Squibb.

The SPICE Study is a Phase I multicenter, open label, non-randomized study of enadenotucirev administered in combination with nivolumab in patients with metastatic or advanced solid tumors (with a focus on non-small cell lung cancer, colorectal cancer and squamous cell cancer of the head and neck) not responding to standard therapy. This study is currently recruiting patients in the USA and it is planned to recruit patients in Spain to the next phase of the study.

For more information about this trial and participating centres, please follow these links:

ClinicalTrials.gov               Poster presented at ESMO 2019

The OCTAVE Study

The OCTAVE Study is a Phase I/II non-randomized multicenter clinical trial of enadenotucirev in combination with paclitaxel administered weekly to patients with platinum-resistant epithelial ovarian cancer.

For more information please follow these links:

ClinicalTrials.Gov               CancerResearchUK.Org

Poster Presented at ESMO 2019

The MECHANISM OF ACTION Study

Now complete, the Mechanism of Action Study was a non-randomized Phase I study to assess the delivery of enadenotucirev and the associated inflammatory immune response within epithelial solid tumors after intravenous infusion or intra-tumoral injection.

For more information about this trial, please follow these links:

ClinicalTrials.Gov               Peer Reviewed Publication – MoA Study

The EVOLVE Study

Now complete, the EVOLVE Study (Evaluating Oncolytic Vaccine Efficacy) was a first-inhuman non-randomized multicenter Phase I clinical study to assess the primary endpoints of dose, safety and tolerability of enadenotucirev delivered intravenously.

For more information about this trial, please follow these links:

ClinicalTrials.Gov                Poster presentation from ESMO IO 2017

Recent Publication: Journal for ImmunoTherapy of Cancer 2019 7:20

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