Study of HRO761 alone or in combination in cancer patients with specific DNA alterations called Microsatellite Instability or Mismatch Repair Deficiency.

Phase 1

Recruiting

• Conditions: Patients with advanced unresectable or metastatic MSIhi or dMMR solid tumors, colorectal cancer (CRC; MSIhi, dMMR

• Registration Number: JPRN-jRCT2031230088
• Lead Sponsor: Hirano Takamitsu

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-05-24
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 9

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.
- Eastern Cooperative Oncology Group (ECOG) Performance Status =<1
- Measurable disease as determined by RECIST version 1.1
- HRO761 s.a. (Arm A) dose finding only: Patients must have a site of disease amenable to biopsy and be a candidate for tumor biopsy according to the treating institution guidelines. Patients must be willing to undergo a new tumor biopsy at screening, and during therapy on the study.
- All patients (Arm A, B and C) will have available archival tumor tissue obtained prior to study treatment initiation (in addition to newly obtained tumor biopsy at screening for Arm A), to allow retrospective MSIhi/dMMR status confirmation.

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.
- 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, except for prior gastrectomy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified