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
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Jih-Hsiang Lee Division of General Internal Medicine
- 陳國興 Division of Hematology & Oncology
- 廖唯昱 Division of General Internal Medicine
- 許嘉林 Division of General Internal Medicine
- Kun-Huei Yeh Division of Hematology & Oncology
- 吳尚俊 Division of Hematology & Oncology
- 蔡子修 Division of General Internal Medicine
- 楊景堯 Division of General Internal Medicine
- SHIH-HUNG YANG Division of Hematology & Oncology
- 梁逸歆 Division of Hematology & Oncology
- YEN-TING LIN Division of Hematology & Oncology
- 徐偉勛 醫學研究部
- CHAO-CHI HO CHAO-CHI HO Division of General Internal Medicine
- James Chih-Hsin Yang Division of Hematology & Oncology
- 吳宗哲 Division of General Internal Medicine
- 廖斌志 Division of Hematology & Oncology
- JIN-YUAN SHIH Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Yu-Min Yeh
Co-Principal Investigator
- Chia-Jui Yen
- 黃怡菁
- 黃怡璇 Division of Hematology & Oncology
- Chun-Hui Lee
- 黃盈慈
- 陳柏全
- 劉奕廷
- 鍾秉軒
- Shang-Hung Chen
- Peng-Chan Lin
- Po-Wen Lin
- Shang-Yin Wu
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Neoplasms
Objectives
This trial aims to evaluate the safety and tolerability of RO7673396 in patients with advanced solid tumors harboring RAS mutations.
The trial is divided into two phases: Phase 1 (dose escalation) and Phase 2 (dose extension).
Phase 1 will determine recommended extension doses (RDEs) of RO7673396.
Phase 2 will evaluate the preliminary antitumor activity of the RDEs determined in Phase 1, as well as other doses with future development potential, in specific solid tumor indications.
Test Drug
Tablets
Active Ingredient
RO7673396
Dosage Form
110
Dosage
NA
Endpoints
• Phase 1: Number of subjects experiencing adverse events (AEs)
• Phase 1: Number of subjects experiencing dose-limiting toxicities (DLTs)
• Phase 2: Objective response rate (ORR) assessed by the trial administrator according to the RECIST v1.1 criteria for evaluating responses to solid tumors.
• Phase 1: Number of subjects experiencing dose-limiting toxicities (DLTs)
• Phase 2: Objective response rate (ORR) assessed by the trial administrator according to the RECIST v1.1 criteria for evaluating responses to solid tumors.
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
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
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
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
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
345 participants
