Clinical Trials List
Protocol NumberYO45758
NCT Number(ClinicalTrials.gov Identfier)NCT06884618
Active
2025-08-01 - 2030-12-31
Phase I
Recruiting2
ICD-10D49.9
Neoplasm of unspecified behavior of unspecified site
ICD-9239.9
Neoplasm of unspecified nature, site unspecified
A Phase I Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Clinical Activity of RO7673396 as a Single Agent and in Combination With Other Anticancer Therapies in Patients With Advanced Solid Tumors Harboring RAS Mutation(s)
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Sponsor
-
Trial scale
Multi-Regional Multi-Center
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Update
2026/08/19
Investigators and Locations
Co-Principal Investigator
- SHIH-HUNG YANG 無
- 許嘉林 無
- Jih-Hsiang Lee 無
- James Chih-Hsin Yang 無
- 梁逸歆 無
- Kun-Huei Yeh 無
- 吳宗哲 無
- YEN-TING LIN 無
- 吳尚俊 無
- 陳國興 無
- 廖斌志 無
- 徐偉勛 無
- 蔡子修 無
- 廖唯昱 無
- JIN-YUAN SHIH 無
- CHAO-CHI HO CHAO-CHI HO 無
- 楊景堯 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Yu-Min Yeh
Co-Principal Investigator
- Peng-Chan Lin Division of Hematology & Oncology
- 劉奕廷 Division of Hematology & Oncology
- Chun-Hui Lee Division of Hematology & Oncology
- Chia-Jui Yen Division of Hematology & Oncology
- Po-Wen Lin Division of General Surgery
- 鍾秉軒 Division of Hematology & Oncology
- 黃盈慈 Division of Hematology & Oncology
- 黃怡菁 Division of Hematology & Oncology
- Shang-Yin Wu Division of Hematology & Oncology
- Shang-Hung Chen Division of Hematology & Oncology
- 陳柏全 Division of General Surgery
- 黃怡璇
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Neoplasms
Objectives
本試驗旨在評估RO7673396在帶有RAS突變的晚期實體腫瘤受試者中的安全性與耐受性。
本試驗分為兩個階段：第1階段（劑量遞增）與第2階段（劑量擴展）。
第1階段將確定RO7673396的建議擴展劑量（RDEs）。
第2階段將評估第1階段所確定之RDE及其他具有未來開發潛力之劑量，在特定實體腫瘤適應症中的初步抗腫瘤活性。
Test Drug
錠劑
Active Ingredient
RO7673396
Dosage Form
110
Dosage
5 mg、50 mg、200 mg
Endpoints
•第1階段：發生不良事件（AEs）的受試者人數
•第1階段：發生劑量限制性毒性（DLTs）的受試者人數
•第2階段：由試驗主持人依據實體腫瘤反應評估標準第 1.1 版（RECIST v1.1）所評估之客觀反應率（ORR）
•第1階段：發生劑量限制性毒性（DLTs）的受試者人數
•第2階段：由試驗主持人依據實體腫瘤反應評估標準第 1.1 版（RECIST v1.1）所評估之客觀反應率（ORR）
Inclution Criteria
Inclusion Criteria:
Histologically documented, locally advanced, recurrent, or metastatic incurable solid tumors
Participants with measurable disease according to RECIST v1.1 assessed by the investigator
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Life expectancy ≥12 weeks
Adequate hematologic and end-organ function
Confirmed presence of the RAS mutation(s)
Histologically documented, locally advanced, recurrent, or metastatic incurable solid tumors
Participants with measurable disease according to RECIST v1.1 assessed by the investigator
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Life expectancy ≥12 weeks
Adequate hematologic and end-organ function
Confirmed presence of the RAS mutation(s)
Exclusion Criteria
Exclusion Criteria:
Current participant or enrollment in another interventional clinical trial
Known hypersensitivity or medical contraindication to any component of RO7673396 formulation
Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant small bowel resection that would preclude adequate study treatment absorption
Known and untreated, or active central nervous system (CNS) metastases
Participants with chronic diarrhea, short bowel syndrome or significant upper gastrointestinal (GI) surgery including gastric resection, a history of inflammatory bowel disease (IBD)
Treatment with chemotherapy, immunotherapy, biologic therapy, or an investigational agent as anti-cancer therapy within 4 weeks or five half-lives prior to initiation of study treatment
Participants who are on acid-reducing agents and unable to safely discontinue them as required in the study
Major surgical procedure within 28 days prior to initiation of study treatment, or incomplete recovery from surgery that would interfere with the determination of safety or efficacy of study treatment, or anticipation of need for a major surgical procedure during the study
Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
Known clinically significant liver disease
Current participant or enrollment in another interventional clinical trial
Known hypersensitivity or medical contraindication to any component of RO7673396 formulation
Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant small bowel resection that would preclude adequate study treatment absorption
Known and untreated, or active central nervous system (CNS) metastases
Participants with chronic diarrhea, short bowel syndrome or significant upper gastrointestinal (GI) surgery including gastric resection, a history of inflammatory bowel disease (IBD)
Treatment with chemotherapy, immunotherapy, biologic therapy, or an investigational agent as anti-cancer therapy within 4 weeks or five half-lives prior to initiation of study treatment
Participants who are on acid-reducing agents and unable to safely discontinue them as required in the study
Major surgical procedure within 28 days prior to initiation of study treatment, or incomplete recovery from surgery that would interfere with the determination of safety or efficacy of study treatment, or anticipation of need for a major surgical procedure during the study
Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
Known clinically significant liver disease
The Estimated Number of Participants
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Taiwan
20 participants
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Global
405 participants
