Genetic vaccine for the treatment of microsatellite unstable solid tumors
Research type
Research Study
Full title
A Phase I/II, Multicenter, Open-Label Study of Nous-209 Genetic Vaccine for the Treatment of Microsatellite Unstable Solid Tumors
IRAS ID
1006323
Contact name
Melanie Pooler
Contact email
Sponsor organisation
Nouscom S.r.l.
Eudract number
2021-002823-40
Clinicaltrials.gov Identifier
Research summary
This is a multi-center, open-label, Phase I/II study in subjects with unresectable or metastatic dMMR or MSI-H CRC, gastric, or G-E junction tumors. The Phase I portion of the study enrolled subjects with unresectable or metastatic MSI-H or dMMR CRC, gastric or G-E junction tumors who are 1st line or those who have progressed following prior treatment.
The Phase II portion of the study will enroll anti-PD-1 naïve subjects with locally advanced unresectable or metastatic MSI-H or dMMR CRC who are eligible for 1st line anti-PD-1 therapy (Cohort C). In addition, a separate cohort (Cohort D) will test Nous-209 in combination with pembrolizumab in subjects with dMMR/MSI-H CRC who have had radiographic progression (PD) after having a best response of stable disease (SD) or better on/after anti-PD1 treatment.
Colorectal cancers that are being considered for the trial are those which are not suitable for surgery (unresectable)-Cohort C or have spread to other parts of the body (metastatic)-Cohort D, and your Investigator has found by taking a biopsy that your cancer is deficient mismatch repair (dMMR) or microsatellite instability high (MSI-H).
Nous-209 is an immunotherapeutic, which means it is given like a flu vaccine which is directed against influenza). In principle, there is a possibility to increase the efficacy of anti-PD-1 checkpoint inhibitor monotherapy through the potentiation of host immunity. We showed that treatment of mice with neoantigen vaccination in combination with an anti-PD-1checkpoint inhibitor results in an increased response rate compared to anti-PD1 monotherapy. This combo therapy might provide a more favorable safety and tolerability profile compared to anti-PD-1 /anti-CTLA4 combination therapy and increase the response rate also in humans, which, as of May 2021, has been confirmed in the preliminary clinical data of the Phase 1 portion of this trial. This is however subject to ongoing research and therefore cannot be guaranteed.REC name
South Central - Oxford A Research Ethics Committee
REC reference
23/SC/0035
Date of REC Opinion
4 Sep 2023
REC opinion
Further Information Favourable Opinion