Clinical Trials List
Protocol NumberIDE892-001
NCT Number(ClinicalTrials.gov Identfier)NCT07277413
Not yet recruiting
2025-11-14 - 2029-06-30
Phase I
Recruiting4
A Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of IDE892 as Monotherapy and Combination Therapy in Participants With MTAP-Deleted Advanced Solid Tumors
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Sponsor
-
Trial scale
Multi-Regional Multi-Center
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Update
2026/08/13
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 廖斌志 Division of Hematology & Oncology
- 黃信端 Division of Hematology & Oncology
- 黃得瑞 Division of Hematology & Oncology
- 黃俊凱 Division of General Internal Medicine
- CHAO-CHI HO CHAO-CHI HO Division of General Internal Medicine
- 楊景堯 Division of General Internal Medicine
- James Chih-Hsin Yang Division of Hematology & Oncology
- Jih-Hsiang Lee Division of Hematology & Oncology
- 吳尚俊 Division of General Internal Medicine
- 廖唯昱 Division of General Internal Medicine
- YEN-TING LIN Division of General Internal Medicine
- 錢穎群 Division of General Internal Medicine
- Chong-Jen Yu Division of General Internal Medicine
- 張立群 Division of General Internal Medicine
- 許嘉林 Division of General Internal Medicine
- 徐偉勛 Division of Hematology & Oncology
- 蔡子修 Division of General Internal Medicine
- Chia-Chi Lin Division of Hematology & Oncology
- 陳冠宇 Division of General Internal Medicine
- 于鎧綸 Division of General Internal Medicine
- 林珮璇 Division of Otolaryngology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Hsu-ching Huang Division of Thoracic Medicine
- 蕭慈慧 Division of Thoracic Medicine
- Chi-Lu Chiang Division of Thoracic Medicine
- 廖映庭 Division of Thoracic Medicine
- Chia-I Shen Division of Thoracic Medicine
- 趙恒勝 Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Chun-Hui Lee
Co-Principal Investigator
- 黃怡璇 Division of Hematology & Oncology
- Yu-Min Yeh Division of Hematology & Oncology
- 鍾秉軒 Division of Hematology & Oncology
- Chien-Chung Lin Division of General Internal Medicine
- 劉奕廷 Division of Hematology & Oncology
- 蔡政軒 Division of General Internal Medicine
- Po-Lan Su Division of General Internal Medicine
- 黃怡菁 Division of Hematology & Oncology
- Shang-Yin Wu Division of Hematology & Oncology
- Chih-Chieh Yen Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
NSCLC Adenocarcinoma
Objectives
[主要目的]
劑量遞增（第 1 與第 3 部分）
第 1 部分：
•評估在具有 MTAP 缺失之局部晚期、復發性或轉移性腫瘤參與者中，逐步增加 IDE892 劑量等級之安全性與耐受性，包括間皮瘤、胃食道癌、胰臟癌與膽道腫瘤、非小細胞肺癌（NSCLC；包含腺癌、鱗狀細胞癌及腺鱗狀細胞癌）以及泌尿上皮癌（UC；膀胱與上泌尿道癌，包含混合型泌尿上皮–鱗狀細胞組織學），以確定最大耐受劑量 (MTD) 和／或建議擴展劑量 (RDE)。
第 3 部分：
•評估 IDE892 與 IDE397 併用時，在具有 MTAP 缺失之局部晚期、復發性或轉移性腫瘤參與者中進行劑量遞增之安全性與耐受性，包括間皮瘤、胃食道癌、胰臟癌與膽道腫瘤、非小細胞肺癌 （NSCLC）及泌尿上皮癌（UC），以確定該併用療法之最大耐受劑量（MTD）及／或建議擴展劑量 （RDE）。
劑量擴展（第 2 與第 4 部分）
第 2 部分：
•進一步評估在具有 MTAP 缺失之晚期或轉移性非小細胞肺癌 (NSCLC) 參與者中，2 個以上低於或等於最大耐受劑量 (MTD) 之 IDE892 劑量等級的安全性與耐受性，以確定第 2 期建議劑量 (RP2D)。
•評估 IDE892 在患有 MTAP 缺失之晚期或轉移性 NSCLC 參與者中的抗腫瘤活性。
第 4 部分：
•進一步評估在具有 MTAP 缺失之晚期或轉移性非小細胞肺癌 (NSCLC) 參與者中，2 個以上低於或等於最大耐受劑量 (MTD) 之 IDE892 與 IDE397 併用劑量等級的安全性與耐受性，以確定第 2 期建議劑量 (RP2D)。
•評估 IDE892 與 IDE397 併用療法在患有 MTAP 缺失之晚期或轉移性 NSCLC 參與者中的抗腫瘤活性。
[次要目的]
劑量遞增（第 1 與第 3 部分）
第 1 和第 3 部分：
•評估 IDE892 作為單藥療法或與 IDE397 併用時，在具有 MTAP 缺失之晚期或轉移性腫瘤參與者中的初步抗腫瘤活性，包括間皮瘤、胃食道癌、胰臟癌與膽道腫瘤、NSCLC 及 UC。
劑量遞增與擴展（第 1 至第 4 部分）
第 1 至第 4 部分：
•透過其他辦法評估 IDE892 作為單藥療法或與 IDE397 併用時，對所關注腫瘤類型的抗腫瘤活性。
•評估 IDE892 作為單藥療法或與 IDE397 併用時的藥物動力學 (PK)。
第 3 與第 4 部分：
•評估 IDE397 與 IDE892 併用時的 PK。
探索性目標（所有試驗部分）
•評估 IDE892 單藥療法或與 IDE397 併用時，對所關注腫瘤類型之事件型結果的影響。
•探討 IDE892 單藥療法或與 IDE397 併用時，治療反應與腫瘤基因及分子型特徵之間的相關性（所有部分）。
•探索安全性、生物標記效應和療效的曝藥量-反應關係。
•評估 IDE892 在靶活性。
•研究 IDE892 單藥或與 IDE397 併用時，IDE892 和 IDE397 在血液、腫瘤組織及循環游離 DNA 中的預測性及 PD 生物標記效應，包括但不限於 DNA/RNA 分析與蛋白質分析，以及其與療效之間的相關性。
•評估 IDE892 的尿液排泄（僅第 1 部分）。
•描述 IDE892 在血漿及尿液中的代謝物特性（僅第 1 部分）。
•評估 IDE892 單藥或與 IDE397 併用時，對 CYP3A 活性的內源性生物標記的影響，特別是血漿 4β‑羥基膽固醇及 4β‑羥基膽固醇／總膽固醇比率（僅限第 1 及第 3 部分）。
Test Drug
錠劑
膠囊劑
錠劑
膠囊劑
錠劑
Active Ingredient
IDE892
IDE397
IDE397
Dosage Form
110
130
110
130
110
Dosage
25 mg and 100 mg
5 mg
15 mg
5 mg
15 mg
Endpoints
第 1 和第 3 部分：
•安全性評估指標：劑量限制性毒性 (DLT) 的發生率；不良事件 (AE)／嚴重不良事件 (SAE) 的發生率和嚴重程度（分級依據：常見不良事件評價標準 [CTCAE] 第 5.0 版）。
第 2 與第 4 部分：
•安全性評估指標：AE/SAE 的發生率和嚴重程度（分級依據：CTCAE 第 5.0 版）。
•療效指標：由試驗主持人依固態腫瘤反應評估標準 (RECIST) 第 1.1 版評估之客觀緩解率（ORR；最佳整體反應為完全緩解 [CR] + 部分緩解 [PR]）及反應持續時間 (DOR)。
•安全性評估指標：劑量限制性毒性 (DLT) 的發生率；不良事件 (AE)／嚴重不良事件 (SAE) 的發生率和嚴重程度（分級依據：常見不良事件評價標準 [CTCAE] 第 5.0 版）。
第 2 與第 4 部分：
•安全性評估指標：AE/SAE 的發生率和嚴重程度（分級依據：CTCAE 第 5.0 版）。
•療效指標：由試驗主持人依固態腫瘤反應評估標準 (RECIST) 第 1.1 版評估之客觀緩解率（ORR；最佳整體反應為完全緩解 [CR] + 部分緩解 [PR]）及反應持續時間 (DOR)。
Inclution Criteria
Inclusion Criteria:
Are ≥ 18 years of age (or the minimum age of consent in accordance with local regulations) at the time of signing the ICF.
Have a histologically confirmed diagnosis of a locally advanced recurrent or metastatic solid tumor type of interest with MTAP deletion (for dose escalation: mesothelioma [pleural or peritoneal], gastroesophageal cancers [squamous and adenocarcinoma of esophagus, gastric adenocarcinoma, gastroesophageal junction cancers], pancreatic adenocarcinoma and biliary tract carcinomas (intrahepatic and extrahepatic cholangiocarcinoma, and gallbladder cancer), NSCLC [adenocarcinoma, squamous cell carcinoma, and adeno-squamous] or UC [including mixed urothelial-squamous histology]; for dose expansion: NSCLC that has progressed on at least one prior line of treatment and for which additional effective standard therapy is not available or for which the participant is not a candidate due to intolerance).
Are willing and able to provide blood/tumor tissue samples for biomarker testing. An archival tumor tissue specimen must be provided for central confirmation of MTAP loss.
Must be willing and able to provide the blood/serum/plasma samples
Have evidence of homozygous loss of MTAP or MTAP deletion (pre-screening available after signing pre-screening ICF)
Have at least 1 measurable lesion according to RECIST version 1.1
Have Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1
Have life expectancy > 3 months
Have adequate bone marrow and organ function
Able to swallow and retain orally administered study drug/IMP.
Are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures
Male and female: willing to use contraception
Are ≥ 18 years of age (or the minimum age of consent in accordance with local regulations) at the time of signing the ICF.
Have a histologically confirmed diagnosis of a locally advanced recurrent or metastatic solid tumor type of interest with MTAP deletion (for dose escalation: mesothelioma [pleural or peritoneal], gastroesophageal cancers [squamous and adenocarcinoma of esophagus, gastric adenocarcinoma, gastroesophageal junction cancers], pancreatic adenocarcinoma and biliary tract carcinomas (intrahepatic and extrahepatic cholangiocarcinoma, and gallbladder cancer), NSCLC [adenocarcinoma, squamous cell carcinoma, and adeno-squamous] or UC [including mixed urothelial-squamous histology]; for dose expansion: NSCLC that has progressed on at least one prior line of treatment and for which additional effective standard therapy is not available or for which the participant is not a candidate due to intolerance).
Are willing and able to provide blood/tumor tissue samples for biomarker testing. An archival tumor tissue specimen must be provided for central confirmation of MTAP loss.
Must be willing and able to provide the blood/serum/plasma samples
Have evidence of homozygous loss of MTAP or MTAP deletion (pre-screening available after signing pre-screening ICF)
Have at least 1 measurable lesion according to RECIST version 1.1
Have Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1
Have life expectancy > 3 months
Have adequate bone marrow and organ function
Able to swallow and retain orally administered study drug/IMP.
Are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures
Male and female: willing to use contraception
Exclusion Criteria
Exclusion Criteria:
Known symptomatic brain metastases requiring supraphysiologic doses of systemic corticosteroids
Have a known primary central nervous system (CNS) malignancy
Have had other malignancies within 2 years prior to the first dose, with some exceptions
Impaired cardiac function or clinically significant cardiac diseases
Have presence of uncontrolled pleural, peritoneal, or pericardial effusion within 2 weeks before the first study dose, requiring recurrent drainage procedures or an indwelling drainage catheter
Have a history of severe infections within 4 weeks prior to the start of study treatment
Hypertension (e.g., > 150/100 mmHg) that cannot be controlled by medications despite optimal medical therapy
Other acute or chronic medical or psychiatric condition
Have a history of immunodeficiency, with a positive human immunodeficiency virus(HIV) test at screening
Known or suspected viral hepatitis with a positive test at screening
Had an adverse reaction to a previous antitumor treatment that has not recovered to CTCAE Grade ≤ 1
Have received chemotherapy within 4 weeks of the first dose of IMP; immunotherapy or biologic targeted antitumor treatments within 2 weeks before the first dose of IMP; small molecule inhibitors within 2 weeks before the first dose of IMP, or other investigational products within 4 weeks
Current radiation-related toxicity or radiation therapy within 2 weeks before the first dose of IMP
Administration of any of the following within 2 weeks before the first dose of IDE892 as a monotherapy: Strong inhibitors or inducers of cytochrome P450, Strong inhibitors of P-glycoprotein, Narrow therapeutic index and sensitive substrates of multidrug and toxin extrusion (MATE)1 and MATE2-K, Narrow therapeutic index and sensitive substrates of P-gp and breast cancer resistance protein
Administration of any of the following within 2 weeks before the first dose of IDE892: Strong inhibitors or inducers of CYP3A4/5, Strong inhibitors of P-gp and/or BCRP, Narrow therapeutic index and sensitive substrates of MATE1 and MATE2-K, Narrow therapeutic index and sensitive substrates of P-gp and BCRP
Use of proton pump inhibitors (PPIs) within 7 days prior to the first dose of IMP or planned use during the study
Use of drugs with known risk for QT prolongation within 2 weeks prior to the first dose of IDE892
Previous treatment with a Amethionine adenosyltransferase 2A (MAT2A) inhibitor and/or Protein arginine N-methyltransferase (PRMT) inhibitor
Major surgery within 4 weeks before study entry
Prior irradiation to > 25% of the bone marrow
Known or suspected hypersensitivity to IDE892
Disease-Specific Eligibility Criteria Eligibility Criteria for Participants with NSCLC (All Parts)
Must have histologically confirmed diagnosis of advanced or metastatic NSCLC that has progressed after prior treatment with platinum chemotherapy and a PD-1/PD-L1 inhibitor (unless contraindicated or participant developed intolerance) in the metastatic setting
Treatment with no more than 3 prior lines in the setting of advanced or metastatic disease.
If considered standard of care and available, participants whose cancers have proven targetable oncogene alterations must have had disease progression on (unless contraindicated or participant developed intolerance) at least 1 prior line containing appropriate targeted therapy.
Eligibility Criteria for Participants with Urothelial Cancer (Bladder and Upper Urinary Tract), Mesothelioma (Pleural or Peritoneal), Pancreatic Adenocarcinoma or Biliary Tract Carcinomas (Intrahepatic and Extrahepatic Cholangiocarcinoma, and Gallbladder Cancer) (Parts 1 and 3)
Must have histologically confirmed diagnosis of advanced or metastatic UC, mesothelioma, gastroesophageal cancer or pancreatic and biliary tract tumors
Must have progressed following at least 1 prior line of therapy
Treatment with no more than 3 prior lines in the setting of advanced or metastatic disease
Ages Eligible for Study
18 Years and older (Adult, Older Adult )
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Known symptomatic brain metastases requiring supraphysiologic doses of systemic corticosteroids
Have a known primary central nervous system (CNS) malignancy
Have had other malignancies within 2 years prior to the first dose, with some exceptions
Impaired cardiac function or clinically significant cardiac diseases
Have presence of uncontrolled pleural, peritoneal, or pericardial effusion within 2 weeks before the first study dose, requiring recurrent drainage procedures or an indwelling drainage catheter
Have a history of severe infections within 4 weeks prior to the start of study treatment
Hypertension (e.g., > 150/100 mmHg) that cannot be controlled by medications despite optimal medical therapy
Other acute or chronic medical or psychiatric condition
Have a history of immunodeficiency, with a positive human immunodeficiency virus(HIV) test at screening
Known or suspected viral hepatitis with a positive test at screening
Had an adverse reaction to a previous antitumor treatment that has not recovered to CTCAE Grade ≤ 1
Have received chemotherapy within 4 weeks of the first dose of IMP; immunotherapy or biologic targeted antitumor treatments within 2 weeks before the first dose of IMP; small molecule inhibitors within 2 weeks before the first dose of IMP, or other investigational products within 4 weeks
Current radiation-related toxicity or radiation therapy within 2 weeks before the first dose of IMP
Administration of any of the following within 2 weeks before the first dose of IDE892 as a monotherapy: Strong inhibitors or inducers of cytochrome P450, Strong inhibitors of P-glycoprotein, Narrow therapeutic index and sensitive substrates of multidrug and toxin extrusion (MATE)1 and MATE2-K, Narrow therapeutic index and sensitive substrates of P-gp and breast cancer resistance protein
Administration of any of the following within 2 weeks before the first dose of IDE892: Strong inhibitors or inducers of CYP3A4/5, Strong inhibitors of P-gp and/or BCRP, Narrow therapeutic index and sensitive substrates of MATE1 and MATE2-K, Narrow therapeutic index and sensitive substrates of P-gp and BCRP
Use of proton pump inhibitors (PPIs) within 7 days prior to the first dose of IMP or planned use during the study
Use of drugs with known risk for QT prolongation within 2 weeks prior to the first dose of IDE892
Previous treatment with a Amethionine adenosyltransferase 2A (MAT2A) inhibitor and/or Protein arginine N-methyltransferase (PRMT) inhibitor
Major surgery within 4 weeks before study entry
Prior irradiation to > 25% of the bone marrow
Known or suspected hypersensitivity to IDE892
Disease-Specific Eligibility Criteria Eligibility Criteria for Participants with NSCLC (All Parts)
Must have histologically confirmed diagnosis of advanced or metastatic NSCLC that has progressed after prior treatment with platinum chemotherapy and a PD-1/PD-L1 inhibitor (unless contraindicated or participant developed intolerance) in the metastatic setting
Treatment with no more than 3 prior lines in the setting of advanced or metastatic disease.
If considered standard of care and available, participants whose cancers have proven targetable oncogene alterations must have had disease progression on (unless contraindicated or participant developed intolerance) at least 1 prior line containing appropriate targeted therapy.
Eligibility Criteria for Participants with Urothelial Cancer (Bladder and Upper Urinary Tract), Mesothelioma (Pleural or Peritoneal), Pancreatic Adenocarcinoma or Biliary Tract Carcinomas (Intrahepatic and Extrahepatic Cholangiocarcinoma, and Gallbladder Cancer) (Parts 1 and 3)
Must have histologically confirmed diagnosis of advanced or metastatic UC, mesothelioma, gastroesophageal cancer or pancreatic and biliary tract tumors
Must have progressed following at least 1 prior line of therapy
Treatment with no more than 3 prior lines in the setting of advanced or metastatic disease
Ages Eligible for Study
18 Years and older (Adult, Older Adult )
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
The Estimated Number of Participants
-
Taiwan
15 participants
-
Global
260 participants
