May. 24, 2023 |
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May. 24, 2023 |
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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 |
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Study of HRO761 alone or in combination in cancer patients with specific DNA alterations called Microsatellite Instability or Mismatch Repair Deficiency. |
Hirano Takamitsu |
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Novartis Pharma. K.K. |
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Toranomon Hills Mori Tower 23-1, Toranomon 1-chome Minato-ku, Tokyo 105-6333, Japan |
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+81-120-003-293 |
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rinshoshiken.toroku2@novartis.com |
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Hirano Takamitsu |
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Novartis Pharma. K.K. |
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Toranomon Hills Mori Tower 23-1, Toranomon 1-chome Minato-ku, Tokyo 105-6333, Japan |
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+81-120-003-293 |
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rinshoshiken.toroku2@novartis.com |
Recruiting |
May. 08, 2023 |
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9 | ||
Interventional |
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single arm study |
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open(masking not used) |
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uncontrolled control |
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single assignment |
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treatment purpose |
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- Patients with advanced unresectable or metastatic MSIhi or MMR deficient (dMMR) solid tumors who have progressed after or are intolerant to prior standard therapy. |
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- Impaired cardiac function or clinically significant cardiac disease |
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18age old over | ||
No limit | ||
Both |
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Patients with advanced unresectable or metastatic MSIhi or dMMR solid tumors, colorectal cancer (CRC |
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ArmA : HRO761 |
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MSIhi, dMMR |
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- Safety: Incidence and severity of AEs including DLTs and SAEs, changes in laboratory values, vital signs, ECGs, and other assessments |
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Novartis Pharma. K.K. |
National Cancer Center Hospital IRB | |
6-5-1 Kashiwanoha, Kashiwa, Chiba | |
+81-3-3542-2511 |
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Chiken_CT@ml.res.ncc.go.jp | |
Approval | |
April. 19, 2023 |
No |
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NCT05838768 | |
Clinical Traials.gov |
US/Belgium/France/Italy/Germany/Israel/Norway/Spain/Sweden/United Kingdom/Singapore/Korea/Taiwan |