drugset / Trial / NCT05838768

Study of HRO761 Alone or in Combination in Cancer Patients With Specific DNA Alterations Called Microsatellite Instability or Mismatch Repair Deficiency.

NCT05838768 ↗

Phase 1 Active not recruiting 123 enrolled Novartis Pharmaceuticals
Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

Start
2023-06-27
Primary completion
2027-08-31
Completion
2027-08-31

Drugs

EvaluationDrugModalityDoseRoute
Subject HRO761 Small molecule — Oral
Subject Irinotecan Small molecule — —
Subject Pembrolizumab Monoclonal antibody — —

Indications