NCT05838768Active, not recruitingPhase 1
Study of HRO761 Alone or in Combination in Cancer Patients With Specific DNA Alterations Called Microsatellite Instability or Mismatch Repair Deficiency.
An Open-label, Multi-center Phase I/Ib Dose Finding and Expansion Study of HRO761 as Single Agent and in Combinations in Patients With Microsatellite Instability-High or Mismatch Repair Deficient Advanced Solid Tumors.
Source: ClinicalTrials.gov · Last updated 21 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 123 (actual)
- First submitted
- 5 Apr 2023
- Start date
- 27 Jun 2023
- Primary completion date
- 31 Aug 2027
- Lead sponsor
- Novartis Pharmaceuticals
- Diseases
- Colorectal cancer
- NCT number
- NCT05838768
- EU CT number
- 2022-502314-93-00
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 123
- From 27 Jun 2023 to the primary completion date, 31 Aug 2027
- 27 sites in 15 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of study drugs (e.g., severe ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection), except for prior gastrectomy.
- Other protocol-defined inclusion/exclusion criteria may apply
Other illness
- Impaired cardiac function or clinically significant cardiac disease
- Clinically significant eye impairment
- Human Immunodeficiency Virus (HIV) infection
- Active Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or Tuberculosis infection. Patients whose disease is controlled under antiviral therapy should not be excluded.
- History of severe hypersensitivity reactions to any ingredient of study drug(s)
Other
- Patients with a primary Central Nervous System (CNS) tumor or tumor metastatic to the CNS
Who the study is looking for
- Patients with advanced unresectable or metastatic MSIhi or MMR deficient (dMMR) solid tumors who have progressed after or are intolerant to prior standard therapy.
- Arm A and C: Patients must have progressed on the most recent therapy for advanced disease including one prior line of immune checkpoint inhibitor therapy.
- Arm B: Patients should have received prior chemotherapy or targeted therapy, and patients should have received prior immune checkpoint inhibitor or should be expected to benefit from immune checkpoint inhibitor therapy.
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
- Measurable disease as determined by RECIST version 1.1
- • All patients (Arm A, B and C) will have available archival tumor tissue obtained prior to study treatment initiation, to allow retrospective MSIhi/dMMR status confirmation. A newly obtained biopsy will only be collected at screening if there is no archival tumor tissue available and if safe and medically feasible according to treating institution's guidelines. Exceptions may be considered after documented discussion with Novartis.
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (27)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.