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Nous-209 Vaccine for Metastatic Cancer

Recruiting in Palo Alto (17 mi)

+50 other locations

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Nouscom SRL

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?Ref: Protocol v9.0, dated 7Nov2023. NOUS-209-01 is a multicenter, open-label, multiple cohorts, clinical study, designed to evaluate safety, tolerability, and immunogenicity, and to detect any preliminary evidence of anti-tumor activity of Nous-209 genetic polyvalent vaccine plus pembrolizumab combination therapy in adult subjects with unresectable or metastatic deficient mismatch repair (dMMR) or MSI-H CRC, gastric, or gastro-esophageal junction (G-E junction) tumors. Nous-209 is based on a heterologous prime/boost regimen composed of the Great Ape Adenovirus GAd20-209-FSP used for priming and Modified Vaccinia virus Ankara MVA-209-FSP used for boosting. The Phase I portion of the study is a first-in-human (FIH) clinical study with a primary objective to elucidate the safety and tolerability of Nous-209 in addition to establishing the recommended Phase 2 dose (RP2D), whereas the Phase II was introduced to assess efficacy as the primary objective.

Eligibility Criteria

Adults over 18 with certain advanced solid tumors (like colorectal, gastric, or gastro-esophageal junction cancers) that are microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR). They must not have used PD-1/PD-L1 inhibitors before and should be in a condition where they can handle biopsies. Participants need to have an acceptable performance status, meet specific blood criteria, use effective contraception if of childbearing potential, and understand the study's consent form.

Inclusion Criteria

I can carry out all my usual activities without help.

I am 18 years old or older.

I have never been treated with anti-PD-1 or anti-PD-L1 drugs.

My cancer was previously tested for dMMR/MSI status.

I am able to care for myself and perform daily activities.

My cancer is known to have high microsatellite instability or mismatch repair deficiency.

My colorectal cancer cannot be surgically removed, has spread, and has worsened after initial improvement with anti-PD1 therapy.

My cancer has been tested for dMMR/MSI status.

I am not pregnant.

My cancer is advanced and has not responded to at least two treatments.

My colorectal cancer is advanced, cannot be surgically removed, and is eligible for immunotherapy.

Exclusion Criteria

My cancer has spread to my brain or its coverings.

I have or might have an autoimmune disease.

I have fluid buildup in my abdomen causing symptoms.

I am currently being treated for a severe infection.

I have an active hepatitis B or C infection needing treatment.

I have been diagnosed with HIV.

I have been using steroids or immunosuppressants recently.

I've had radiation on over half of my lymph node groups.

I have used immunosuppressive drugs in the last 3 months.

I will not need any cancer treatment other than the study drugs while participating.

I do not have active lung disease needing steroids or oxygen levels below 92%.

I had major surgery less than 4 weeks before starting pembrolizumab.

I have fluid buildup in my abdomen.

I have not received a live-virus vaccine within the last 30 days.

I have been treated with immune system targeting drugs before.

I have an active Hepatitis B or C infection.

I have an abscess inside my abdomen.

I have a known history of HIV or AIDS.

I have a condition that weakens my immune system.

I need surgery for a blockage in my digestive tract.

Participant Groups

The trial is testing Nous-209 genetic vaccine combined with pembrolizumab for treating MSI-H/dMMR tumors. It uses two types of viruses for priming and boosting the immune system. The first phase focuses on safety and finding the right dose; the second phase looks at how well it works against cancer.

4Treatment groups

Experimental Treatment

Group I: Cohort D - Expansion cohort Phase IIExperimental Treatment3 Interventions

Phase II. Subjects with locally advanced unresectable or metastatic, microsatellite instability high (MSI-H) or dMMR CRC who have had radiographic progression (PD) after having a best response of stable disease (SD) or better on/after anti-PD1 treatment. Nous-209 vaccine plus Keytruda® (pembrolizumab) combination therapy.

Group II: Cohort C - Expansion cohort Phase IIExperimental Treatment3 Interventions

Phase II. Subjects with locally advanced unresectable or metastatic, microsatellite instability high (MSI-H) or dMMR CRC who are eligible for anti-PD-1 1st line of treatment. Subjects will be randomized with an allocation ratio 2:1 to Nous-209 vaccine plus Keytruda® (pembrolizumab) combination therapy versus pembrolizumab monotherapy.

Group III: Cohort B - Expansion Cohort Phase IExperimental Treatment3 Interventions

Phase I. Part 1. Expansion cohort at RP2D. Subjects treated with RP2D dose of GAd20-209-FSP prime and MVA-209-FSP boosts, in combination with pembrolizumab. Phase I. Part 2 - Extended Follow-up from week 27 to week 110. Subjects with unresectable or metastatic dMMR or MSI-H CRC, gastric, or G-E junction tumors.

Group IV: Cohort A - Dose-escalationExperimental Treatment3 Interventions

Phase I. Part 1. Dose escalation cohort. Subjects treated with low dose or with high dose of GAd20-209-FSP prime and MVA-209-FSP boosts to define the RP2D, in combination with pembrolizumab. Phase I. Part 2 - Extended Follow-up from week 27 to week 110. Subjects with unresectable or metastatic deficient mismatch repair (dMMR) or MSI-H CRC, gastric, or gastro-esophageal junction (G-E junction) tumors.