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NCT04046445 · ClinicalTrials.gov registry record · Phase 1
Phase 1b Study to Evaluate ATP128, VSV-GP128 and BI 754091, in Patients With Stage IV Colorectal Cancer
A Phase 1 study of Colorectal Cancer and Metastatic Colorectal Cancer, sponsored by Amal Therapeutics.
- Active
- Registry status
- Phase 1
- Development phase
- 96
- Enrollment target
- 12
- Study locations
NCT04046445 is a Phase 1 study of Colorectal Cancer and Metastatic Colorectal Cancer that is active but no longer recruiting, run by Amal Therapeutics. The registered enrollment target is 96 participants, below the 1,511-participant average among 369 other Colorectal Cancer trials with a reported enrollment target (94% lower). The trial reports 12 study locations across 8 states.
The verdict
NCT04046445, a Phase 1 study of Colorectal Cancer and Metastatic Colorectal Cancer, is active but no longer recruiting, sponsored by Amal Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 96 participants
- Enrollment target
- 12
- Study locations
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?
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, categorized as Phase 1. The registered enrollment target is 96 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,511-participant average among 369 other Colorectal Cancer trials with a reported enrollment target (94% lower). The listed sponsor is Amal Therapeutics, which has 1 total studies on file at ClinicalTrials.gov.
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.
NCT04046445 reports 12 study locations spanning 8 distinct geographic areas - top geographies include Other, New York, Arizona.
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.
What interventions are being tested in trial NCT04046445?
The interventions under investigation include: ATP128 (DRUG), BI 754091 (DRUG), VSV-GP128 (DRUG).
Who is sponsoring clinical trial NCT04046445?
This trial is sponsored by Amal Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov.
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.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.