Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| MSIhi or dMMR Advanced Unresectable or Metastatic Solid Tumors, Including Colorectal Cancers | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HRO761 | Drug | WRN Inhibitor HRO761 | ALIAS |
| irinotecan | Drug | Irinotecan | ALIAS |
| pembrolizumab | Biological | Pembrolizumab | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- A: HRO761 single agent
- description
- phase Ib (Dose finding (Escalation and Optimization) and expansion)
- interventionNames
- Drug: HRO761
- type
- EXPERIMENTAL
- label
- B: HRO761 + pembrolizumab
- description
- phase Ib (Dose escalation and expansion)
- interventionNames
- Drug: HRO761
- Biological: pembrolizumab
- type
- EXPERIMENTAL
- label
- C: HRO761 + irinotecan
- description
- phase Ib (Dose escalation and expansion)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Key Inclusion criteria: * 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. Key Exclusion criteria: * Impaired cardiac function or clinically significant cardiac disease * Clinically significant eye impairment * Patients with a primary Central Nervous System (CNS) tumor or tumor metastatic to the CNS * 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) * 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
References
Publications (0)
Data not yet available