Clinical Trials List
Protocol NumberIDE397-001
NCT Number(ClinicalTrials.gov Identfier)NCT04794699
Active
2023-05-01 - 2025-12-31
Phase I
Recruiting2
An Open Label, Phase 1, Treatment Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of IDE397 (MAT2A Inhibitor) In Adult Participants With Advanced Solid Tumors
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Trial Applicant
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 徐偉勛 Division of Hematology & Oncology
- Jih-Hsiang Lee Division of Hematology & Oncology
- Wei-Wu Chen Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Chun-Hui Lee
Co-Principal Investigator
- Shang-Yin Wu Division of Hematology & Oncology
- Yu-Min Yeh Division of Hematology & Oncology
- Chien-Chung Lin Division of Hematology & Oncology
- 鍾秉軒 Division of Hematology & Oncology
- Seu-Chun Yang Division of Hematology & Oncology
- Wen-Pin Su Division of Hematology & Oncology
- Chin-Wei Kuo Division of Hematology & Oncology
- Wu-Chou Su Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Solid Tumor
Objectives
Primary Objectives
• To evaluate the safety and tolerability of IDE397 at increasing dose levels in a consecutive cohort of participants with selected advanced or metastatic solid tumors to estimate the maximum tolerated dose (MTD) and/or recommended second-phase dose (RP2D)/time series (Part 1: Dose escalation of IDE397 monotherapy).
• To further evaluate the safety and tolerability of IDE397 (MTD and/or RP2D) monotherapy (Part 2: Dose extension of IDE397 monotherapy).
• To evaluate the safety and tolerability of IDE397 at increasing dose levels in combination with docetaxel, paclitaxel, gemcitabine, and nab-paclitaxel or pemtrexed (Part 3: Dose escalation of IDE397 in combination with docetaxel or paclitaxel, Part 5: Dose escalation of IDE397 in combination with Gemcitabine + nab-paclitaxel, Part 7: Dose escalation of IDE397 in combination with pemtrexed). • Further evaluate the safety and tolerability of IDE397 (MTD and/or RP2D) in combination with docetaxel, paclitaxel, gemcitabine, and nab-paclitaxel or pemtrexed (Part 4: Treatment dose extension of IDE397 in combination with docetaxel or paclitaxel, Part 6: Treatment dose extension of IDE397 in combination with gemcitabine and nab-paclitaxel, Part 8: Treatment dose extension of IDE397 in combination with pemtrexed).
• Evaluate preliminary antitumor activity (Parts 2, 4, 6, and 8).
Secondary Objectives
• Investigate the single-dose and multiple-dose pharmacokinetics (PK) of IDE397 and its metabolites as monotherapy and in combination with docetaxel, paclitaxel, gemcitabine, and nab-paclitaxel or pemtrexed (all parts) after oral administration.
• Evaluate drug interactions between IDE397 and paclitaxel or docetaxel (Parts 3 and 4).
• Evaluate drug interactions between IDE397 and nab-paclitaxel or Gemcitabine (Parts 5 and 6).
• Evaluate drug interactions between IDE397 and pemmetrexed (Parts 7 and 8).
• Evaluate the drug-disorder (PD) effects of IDE397 as a single agent and in combination with docetaxel, paclitaxel, gemcitabine, and nab-paclitaxel or pemmetrexed (all parts).
• Evaluate preliminary antitumor activity (Parts 1, 3, 5, and 7).
• Evaluate the efficacy of IDE397 as a single agent and in combination with docetaxel, paclitaxel, gemcitabine, nab-paclitaxel, and pemmetrexed by a blinded imaging review committee (Parts 1, 2, 3, 4, 5, 6, 7, and 8).
Third/Exploratory/Other Purposes
• Explore any correlations between tumor genetic and molecular profiles and responses to IDE397 (all parts).
• Explore the predictive and PD effects of IDE397 on responding tumors and cell-free DNA (all parts).
• Investigate the metabolite profile of IDE397 in tumors and plasma (all parts).
• Further investigate the preliminary antitumor activity of IDE397 (all parts).
• Assess the urinary excretion of IDE397 and its metabolites (Part 1).
• Correlation of PK/PD results (all parts).
• Assess early response in participants with gastric esophageal cancer (EG) using PET/CT (Part 2, Group 2).
• Food effect trial: Assess the effect of food on the pharmacokinetics of IDE397 in cancer patients.
Test Drug
錠劑
注射用凍晶粉末
注射用凍晶粉末
Active Ingredient
IDE397
sacituzumab govitecan
sacituzumab govitecan
Dosage Form
110
048
048
Dosage
15 mg/tablet, 50 mg/tablet
180 mg vials
180 mg vials
Endpoints
• Incidence of dose-limiting toxicities (DLTs).
• Incidence of treatment-related adverse events by type, frequency, severity (graded according to the National Cancer Institute Criteria for Adverse Events [NCI-CTCAE, version 5.0]), time, severity, and relevance to the trial treatment.
• Incidence of laboratory abnormalities by type, frequency, severity (graded according to NCI CTCAE version 5.0), and time.
• Tumor response: Objective response rate (ORR) and duration of response (DoR) assessed by the trial administrator using the Responsive Criteria for Solid Tumor Response (RECIST version 1.1, Appendix 7).
• Incidence of treatment-related adverse events by type, frequency, severity (graded according to the National Cancer Institute Criteria for Adverse Events [NCI-CTCAE, version 5.0]), time, severity, and relevance to the trial treatment.
• Incidence of laboratory abnormalities by type, frequency, severity (graded according to NCI CTCAE version 5.0), and time.
• Tumor response: Objective response rate (ORR) and duration of response (DoR) assessed by the trial administrator using the Responsive Criteria for Solid Tumor Response (RECIST version 1.1, Appendix 7).
Inclution Criteria
Inclusion Criteria:
Participant must be at least 18 years of age
Advanced or metastatic solid tumor that has progressed on at least one prior line of treatment or is intolerant to additional effective standard therapy
Have evidence of homozygous loss of MTAP or MTAP deletion
Willing to undergo paired fresh biopsy (pre- and post-treatment) procedure. Exceptions may be made for feasibility and safety concerns
Measurable disease
ECOG performance status <= 1
Adequate organ function
Able to swallow and retain orally administered study treatment
Recovery from acute effects of prior therapy
Able to comply with contraceptive/barrier requirements
Participant must be at least 18 years of age
Advanced or metastatic solid tumor that has progressed on at least one prior line of treatment or is intolerant to additional effective standard therapy
Have evidence of homozygous loss of MTAP or MTAP deletion
Willing to undergo paired fresh biopsy (pre- and post-treatment) procedure. Exceptions may be made for feasibility and safety concerns
Measurable disease
ECOG performance status <= 1
Adequate organ function
Able to swallow and retain orally administered study treatment
Recovery from acute effects of prior therapy
Able to comply with contraceptive/barrier requirements
Exclusion Criteria
Exclusion Criteria:
Known symptomatic brain metastases
Known primary CNS malignancy
Current active liver or biliary disease
Impairment of gastrointestinal (GI) function
Active uncontrolled infection
Clinically significant cardiac abnormalities
Previous treatment with a MAT2A inhibitor and / or PRMT inhibitor or sacituzumab govitecan
Systemic anti-cancer therapy or major surgery within 4 weeks prior to study entry
Radiation therapy within 2 weeks prior to study entry
Prior irradiation to >25% of the bone marrow
Current use or anticipated need for food or drugs that are known strong CYP3A4/5 inhibitors or inducers
Currently receiving another investigational study drug.
Known or suspected hypersensitivity to IDE397/excipients or components
Known symptomatic brain metastases
Known primary CNS malignancy
Current active liver or biliary disease
Impairment of gastrointestinal (GI) function
Active uncontrolled infection
Clinically significant cardiac abnormalities
Previous treatment with a MAT2A inhibitor and / or PRMT inhibitor or sacituzumab govitecan
Systemic anti-cancer therapy or major surgery within 4 weeks prior to study entry
Radiation therapy within 2 weeks prior to study entry
Prior irradiation to >25% of the bone marrow
Current use or anticipated need for food or drugs that are known strong CYP3A4/5 inhibitors or inducers
Currently receiving another investigational study drug.
Known or suspected hypersensitivity to IDE397/excipients or components
The Estimated Number of Participants
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Taiwan
5 participants
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Global
180 participants
