Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04041310 · ClinicalTrials.gov registry record · Phase 1
Nous-209 Genetic Vaccine for the Treatment of Microsatellite Unstable Solid Tumors
A Phase 1 study of Solid Tumor, Adult, sponsored by Nouscom SRL.
- Active
- Registry status
- Phase 1
- Development phase
- 115
- Enrollment target
- 20
- Study locations
NCT04041310: Active Phase 1 study of Solid Tumor, Adult, sponsored by Nouscom SRL.
NCT04041310 is a Phase 1 study of Solid Tumor, Adult that is active but no longer recruiting, run by Nouscom SRL. The registered enrollment target is 115 participants, below the 189-participant average among 72 other Solid Tumor, Adult trials with a reported enrollment target (39% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04041310, a Phase 1 study of Solid Tumor, Adult, is active but no longer recruiting, sponsored by Nouscom SRL.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 115 participants
- Enrollment target
- 20
- Study locations
Study Summary
Ref: Protocol Version 9.1 05 December 2024. 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.
Primary Outcome
Toxicity analyzed within 28-days from the administration of the prime vaccination with GAd20-209-FSP
Conditions Studied
Interventions
- BIOLOGICAL GAd-209-FSP low dose
- BIOLOGICAL MVA-209-FSP low dose
- BIOLOGICAL GAd-209-FSP high dose
- BIOLOGICAL MVA-209-FSP high dose
- BIOLOGICAL GAd20-209-FSP, RP2D
Study Locations (20)
Other
- Cliniques Universitaires Saint-Luc - Centre du Cancer - Brussels
- Centre Hospitalier de l'Ardenne - Libramont - Clinique du Sein - Libramont
- CHU de Liège - Liège
- Mount Sinai Hospital - Toronto
- Princess Margaret Cancer Center - Toronto
- Aorn Sg Moscati - Avellino
- Candiolo cancer Center,FPO IRCCS - Candiolo
California
- City of Hope Comprehensive Cancer Center - Duarte
- City of Hope Comprehensive Cancer Center - Irvine
- USC Norris Comprehensive Cancer Center - Los Angeles
- USC Norris Comprehensive Cancer Center - Newport Beach
New York
- Roswell Park Comprehensive Cancer Center - Buffalo
- NYU Langone Medical Center - New York
- Weill Cornell Medicine / New York-Presbyterian Hospital - New York
Florida
- Mt. Sinai - Miami Beach
- Boca Raton Clinical Research - Plantation
Indiana
- Goshen Center for Cancer Care - Goshen
Maryland
- Johns Hopkins University - Baltimore
Missouri
- Washington University School of Medicine, Division of Oncology - St Louis
Texas
- MD Anderson Cancer Center (MDACC) - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 115 participants |
| Start Date | 2019-10-21 |
| Est. Completion | 2026-10-30 |
| Phase | Phase 1 |
What the registry record for NCT04041310 still lists
NCT04041310 is an interventional study that assigns participants to a tested intervention. The registered 115 participants enrollment target is mid-sized for trials with a published cap, below the 189-participant average among 72 other Solid Tumor, Adult trials with a reported enrollment target (39% lower).
The record links to 1 condition, with Solid Tumor, Adult appearing as the primary indexed condition, and to 5 interventions - of which GAd-209-FSP low dose is the first listed.
NCT04041310 names 20 study sites across 8 states, led by Other, California, New York.
Frequently Asked Questions
What is clinical trial NCT04041310 about?
NCT04041310 is a clinical study titled "Nous-209 Genetic Vaccine for the Treatment of Microsatellite Unstable Solid Tumors". Ref: Protocol Version 9.1 05 December 2024. 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 pembrolizum...
What is the current status of trial NCT04041310?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 115 participants. The study started on 2019-10-21. Estimated completion is 2026-10-30.
What conditions does trial NCT04041310 study?
This clinical trial studies the following conditions: Solid Tumor, Adult.
What interventions are being tested in trial NCT04041310?
The interventions under investigation include: GAd-209-FSP low dose (BIOLOGICAL), MVA-209-FSP low dose (BIOLOGICAL), GAd-209-FSP high dose (BIOLOGICAL), MVA-209-FSP high dose (BIOLOGICAL), GAd20-209-FSP, RP2D (BIOLOGICAL).
Who is sponsoring clinical trial NCT04041310?
This trial is sponsored by Nouscom SRL, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04041310 being conducted?
This trial has 20 study locations across California, Florida, Indiana, Maryland, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Solid Tumor, Adult
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04041310's enrollment target sits among peer trials
115 37th of 72 higher than 36 of 72 other Solid Tumor, Adult trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Solid Tumor, Adult trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Study of CRX100 as Monotherapy and in Combination With Pembrolizumab in Patients With Advanced Solid Malignancies
RECRUITING · Phase 1
-
Open-Label, Dose-Escalation With Expansion to Assess the Safety, Tolerability, and PK of TRE-515 in Subjects With Solid Tumors
RECRUITING · Phase 1
-
A Study of BI-1206 in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors
RECRUITING · Phase 1
-
Phase 1 Study to Investigate TCRTs KRAS Mutation in Unresectable, Advanced, and/or Metastatic Solid Tumors
RECRUITING · Phase 1
-
Study Assessing MTD, Safety, Tolerability, PK and Anti-tumor Effects of LNS8801alone and With Pembrolizumab
RECRUITING · Phase 1
-
A Study to Investigate the Safety and Efficacy of NST-628 Oral Tablets in Subjects With Solid Tumors
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02346929 · 115 participants · NA
Hematoma Block for Distal Radius Fracture
- NCT03394365 · 115 participants · Phase 3
A Phase 3 Study of Tabelecleucel for Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure With Rituximab or Rituximab and Chemotherapy
- NCT03907475 · 115 participants · Phase 2
Durvalumab in Combination With Chemotherapy in Treating Patients With Advanced Solid Tumors, DURVA+ Trial
- NCT05086692 · 115 participants · Phase 1
A Beta-only IL-2 ImmunoTherapY Study
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI