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

JRCT ID: jRCT2031230088

Registered date:24/05/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients with advanced unresectable or metastatic MSIhi or dMMR solid tumors, colorectal cancer (CRC
• Date of first enrollment: 08/05/2023
• Target sample size: 9
• Countries of recruitment: US,Japan,Belgium,Japan,France,Japan,Italy,Japan,Germany,Japan,Israel,Japan,Norway,Japan,Spain,Japan,Sweden,Japan,United Kingdom,Japan,Singapore,Japan,Korea,Japan,Taiwan,Japan
• Study type: Interventional

Intervention(s)

ArmA : HRO761
ArmB : HRO761 in combination with tislelizumab
ArmC : HRO761 in combination with irinotecan

Outcome(s)

Primary Outcome

- Safety: Incidence and severity of AEs including DLTs and SAEs, changes in laboratory values, vital signs, ECGs, and other assessments
- Tolerability: Dose interruptions, discontinuations, and reductions

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Hirano Takamitsu
• Secondary ID(s): NCT05838768