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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 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. The trial reports 20 study locations across 8 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05838768
The ClinicalTrials.gov registry entry for NCT05838768 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 327 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 8 distinct geographic areas - top geographies include 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.
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