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Japanese

May. 24, 2023

May. 24, 2023

jRCT2031230088

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

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

Hirano Takamitsu

Novartis Pharma. K.K.

Toranomon Hills Mori Tower 23-1, Toranomon 1-chome Minato-ku, Tokyo 105-6333, Japan

+81-120-003-293

rinshoshiken.toroku2@novartis.com

Hirano Takamitsu

Novartis Pharma. K.K.

Toranomon Hills Mori Tower 23-1, Toranomon 1-chome Minato-ku, Tokyo 105-6333, Japan

+81-120-003-293

rinshoshiken.toroku2@novartis.com

Recruiting

May. 08, 2023

9

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

- 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.

- 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.

18age old over
No limit

Both

Patients with advanced unresectable or metastatic MSIhi or dMMR solid tumors, colorectal cancer (CRC

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

MSIhi, dMMR

- 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

Novartis Pharma. K.K.
National Cancer Center Hospital IRB
6-5-1 Kashiwanoha, Kashiwa, Chiba

+81-3-3542-2511

Chiken_CT@ml.res.ncc.go.jp
Approval

April. 19, 2023

No

NCT05838768
Clinical Traials.gov

US/Belgium/France/Italy/Germany/Israel/Norway/Spain/Sweden/United Kingdom/Singapore/Korea/Taiwan