Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Phase 1b Study to Evaluate ATP128, VSV-GP128 and BI 754091, in Patients With Stage IV Colorectal Cancer
NCT04046445 · View on ClinicalTrials.gov ↗
Study Summary
This is a multi-center, non-randomised Phase 1b study to evaluate the safety and tolerability of ATP128 alone or in combination with BI 754091 and of heterologous prime-boost ATP128 + VSV-GP128 in combination with BI 754091. ATP128 is a self-adjuvanted chimeric recombinant protein vaccine being developed in combination with programmed cell death 1 (PD-1) blockade for the treatment of microsatellite stable (MSS) patients not responding to PD-1 blockade. The PD-1 inhibitor being tested with ATP128 is the BI 754091 (Ezabenlimab) compound which belongs to the human immunoglobulin G4 (IgG4) subclass of antibodies. VSV-GP is a recombinant chimeric vesicular stomatitis virus (VSV, Indiana strain Rhabdoviridae) which carries the envelope glycoprotein (GP) of the visceral non neurotropic WE-HPI strain of the Lymphocytic choriomeningitis virus (LCMV, Arenaviridae) instead of the native VSV glycoprotein (G) and is developed as integral part of the prime-boost regimen together with ATP128. The Sponsor plans to enrol 96 patients with histologically or cytologically confirmed stage IV colorectal cancer coming form three different patient populations: * Cohort 1a: 6 patients with stage IV colorectal cancer (CRC) having failed standard of care (SoC) therapies * Cohorts 1b, 2a, 2c: 30 patients with stage IV microsatellite stable/mismatch repair-proficient (MSS/MMRp) CRC being in stable disease (SD) or partial response (PR) after first line of SoC (4-6 months duration at minimum) * Cohorts 2b, 4b: 30 patients with stage IV MSS/MMRp liver-limited disease Patients eligible for this study will be enrolled in one of the 8 cohorts depending on their disease: * Patients in Cohort 1a will receive ATP128 as single agent * Patients in Cohorts 1b, 2a, 2b, 2c will receive ATP128 in combination with BI 754091 * Patients in Cohorts 3, 4a, 4b will receive ATP128 and VSV-GP128 in combination with BI 754091
Conditions Studied
Interventions
- DRUG ATP128
- DRUG BI 754091
- DRUG VSV-GP128
Study Locations (12)
Other
- University Hospital Antwerpen — Edegem
- University Hospital Leuven — Leuven
- University Medicine Mainz — Mainz
- Geneva University Hospitals — Geneva
New York
- NYU Langone Health — New York
- Weill Cornell Medicine — New York
Arizona
- Honor Health Institute — Scottsdale
California
- University of Southern California — Los Angeles
Colorado
- University of Colorado Anschutz Medical Campus — Aurora
North Carolina
- Duke Cancer Institute — Durham
Texas
- University of Texas, MD Anderson Cancer Center — Houston
Canton of Zurich
- University Hospital Zurich — Zurich
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2019-07-22 |
| Est. Completion | 2025-08-31 |
| Phase | Phase 1 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04046445
The ClinicalTrials.gov registry entry for NCT04046445 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 96 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amal Therapeutics, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 6 conditions, with Colorectal Cancer appearing as the primary indexed condition, and to 3 interventions — of which ATP128 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04046445 reports 12 study locations spanning 8 distinct geographic areas — top geographies include Other, New York, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04046445 about?
NCT04046445 is a clinical study titled "Phase 1b Study to Evaluate ATP128, VSV-GP128 and BI 754091, in Patients With Stage IV Colorectal Cancer". This is a multi-center, non-randomised Phase 1b study to evaluate the safety and tolerability of ATP128 alone or in combination with BI 754091 and of heterologous prime-boost ATP128 + VSV-GP128 in combination with BI 754091. ATP128 is a self-adjuvanted chimeric recombinant protein vaccine being dev...
What is the current status of trial NCT04046445?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 96 participants. The study started on 2019-07-22. Estimated completion is 2025-08-31.
What conditions does trial NCT04046445 study?
This clinical trial studies the following conditions: Colorectal Cancer, Metastatic Colorectal Cancer, Stage IV Colon Cancer, Stage IV Rectal Cancer, Liver Metastasis Colon Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04046445?
The interventions under investigation include: ATP128 (DRUG), BI 754091 (DRUG), VSV-GP128 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04046445?
This trial is sponsored by Amal Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04046445 being conducted?
This trial has 12 study locations across Arizona, California, Colorado, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.