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NCT05838768 · ClinicalTrials.gov registry record · Phase 1
Study of HRO761 Alone or in Combination in Cancer Patients With Specific DNA Alterations Called Microsatellite Instability or Mismatch Repair Deficiency.
A Phase 1 study of MSIhi or dMMR Advanced Unresectable or Metastatic Solid Tumors, Including Colorectal Cancers, sponsored by Novartis Pharmaceuticals.
- Active
- Registry status
- Phase 1
- Development phase
- 327
- Enrollment target
- 20
- Study locations
NCT05838768: Active Phase 1 study of MSIhi or dMMR Advanced Unresectable or Metastatic Solid Tumors, Including Colorectal Cancers, sponsored by Novartis Pharmaceuticals.
NCT05838768 is a Phase 1 study of MSIhi or dMMR Advanced Unresectable or Metastatic Solid Tumors, Including Colorectal Cancers that is active but no longer recruiting, run by Novartis Pharmaceuticals. The registered enrollment target is 327 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (445% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05838768, a Phase 1 study of MSIhi or dMMR Advanced Unresectable or Metastatic Solid Tumors, Including Colorectal Cancers, is active but no longer recruiting, sponsored by Novartis Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 327 participants
- Enrollment target
- 20
- Study locations
Study Summary
The main purpose of the study is to evaluate the safety and tolerability of HRO761 and identify the recommended dose(s), i.e., the optimal safe and active dose of HRO761 alone or in combination with pembrolizumab or irinotecan that can be given to patients who have cancers with specific molecular alterations called MSIhi (Microsatellite Instability-high) or dMMR (Mismatch Repair Deficient) that might work best to treat these specific cancer types and to understand how well HRO761 is able to treat those cancers.
Primary Outcome
Month 36 is assumed to be study end. Incidence and severity of AEs and SAEs by treatment group, including changes in vital signs, electrocardiograms (ECGs) and laboratory results qualifying and reported as AEs.
Conditions Studied
Interventions
- BIOLOGICAL pembrolizumab
- DRUG HRO761
- DRUG irinotecan
Study Locations (20)
Other
- Novartis Investigative Site - Brussels
- Novartis Investigative Site - Beijing
- Novartis Investigative Site - Guangzhou
- Novartis Investigative Site - Bordeaux
- Novartis Investigative Site - Marseille
- Novartis Investigative Site - Toulouse
- Novartis Investigative Site - Essen
- Novartis Investigative Site - Tel Aviv
- Novartis Investigative Site - Oslo
- Novartis Investigative Site - Singapore
California
- University of California LA - Los Angeles
- UCSF - San Francisco
New York
- Memorial Sloan Kettering - New York
- Columbia University Medical Ctr - New York
MI
- Novartis Investigative Site - Milan
- Novartis Investigative Site - Rozzano
Massachusetts
- Dana Farber Cancer Institute - Boston
Texas
- Univ of TX MD Anderson Cancer Cntr - Houston
Thuringia
- Novartis Investigative Site - Jena
Chiba
- Novartis Investigative Site - Kashiwa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 327 participants |
| Start Date | 2023-06-27 |
| Est. Completion | 2027-08-31 |
| Phase | Phase 1 |
What the registry record for NCT05838768 still lists
NCT05838768 is an interventional study that assigns participants to a tested intervention. The registered 327 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (445% higher).
The record links to 1 condition, with MSIhi or dMMR Advanced Unresectable or Metastatic Solid Tumors, Including Colorectal Cancers appearing as the primary indexed condition, and to 3 interventions - of which pembrolizumab is the first listed.
NCT05838768 names 20 study sites across 8 states, led by Other, California, New York.
Frequently Asked Questions
What is clinical trial NCT05838768 about?
NCT05838768 is a clinical study titled "Study of HRO761 Alone or in Combination in Cancer Patients With Specific DNA Alterations Called Microsatellite Instability or Mismatch Repair Deficiency.". The main purpose of the study is to evaluate the safety and tolerability of HRO761 and identify the recommended dose(s), i.e., the optimal safe and active dose of HRO761 alone or in combination with pembrolizumab or irinotecan that can be given to patients who have cancers with specific molecular al...
What is the current status of trial NCT05838768?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 327 participants. The study started on 2023-06-27. Estimated completion is 2027-08-31.
What conditions does trial NCT05838768 study?
This clinical trial studies the following conditions: MSIhi or dMMR Advanced Unresectable or Metastatic Solid Tumors, Including Colorectal Cancers.
What interventions are being tested in trial NCT05838768?
The interventions under investigation include: pembrolizumab (BIOLOGICAL), HRO761 (DRUG), irinotecan (DRUG).
Who is sponsoring clinical trial NCT05838768?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05838768 being conducted?
This trial has 20 study locations across California, Massachusetts, New York, Texas, Thuringia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05838768's enrollment target sits among peer trials
327 111th of 2000 higher than 1,890 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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
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