Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Active Phase 1 study of Colorectal Cancer and Metastatic Colorectal Cancer, sponsored by Amal Therapeutics.
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 1,544-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (94% lower). The trial reports 12 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Safety
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 |
What the registry record for NCT04046445 still lists
NCT04046445 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 96 participants, a relatively small participant target, below the 1,544-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (94% lower).
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 lists 12 locations in 8 states (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.
Learn More About Clinical Trials
Similar trials for Colorectal Cancer
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 NCT04046445's enrollment target sits among peer trials
96 224th of 381 higher than 158 of 381 other Colorectal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colorectal Cancer 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
-
Phase 1 Trial of ZM008 as Single Agent and in Combination With Pembrolizumab in Patients With Advanced Solid Tumors
RECRUITING · Phase 1
-
[18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications
RECRUITING · Phase 1
-
Beamion BCGC-1: A Study to Find a Suitable Dose of Zongertinib Used Alone and in Combination With Other Treatments to Test Whether it Helps People With Different Types of HER2+ Cancer That Has Spread
RECRUITING · Phase 1
-
Study of CRX100 as Monotherapy and in Combination With Pembrolizumab in Patients With Advanced Solid Malignancies
RECRUITING · Phase 1
-
A Study to Investigate ALE.P03 as Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+ Solid Tumors
RECRUITING · Phase 1
-
Phase I Study of [177Lu]Lu-NNS309 in Patients With Pancreatic, Lung, Breast and Colorectal Cancers
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
- NCT03401762 · 96 participants · NA
Wearable MCI to Reduce Muscle Co-activation in Acute and Chronic Stroke
- NCT03471260 · 96 participants · Phase 1
Ivosidenib and Venetoclax With or Without Azacitidine in Treating Patients With IDH1 Mutated Hematologic Malignancies
- NCT03549559 · 96 participants · NA
Imaging Histone Deacetylase in the Heart
- NCT03841058 · 96 participants · Phase 2
Abaloparatide vs. Placebo in Post-Menopausal Women and Abaloparatide in Men Receiving Initial Spinal Fusion Surgery
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