Clinical Trials List
Protocol NumberSNOF-001
NCT Number(ClinicalTrials.gov Identfier)NCT06143774
Active
2023-09-30 - 2026-06-30
Phase I
Recruiting3
ICD-10C00.0
Malignant neoplasm of external upper lip
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9140.0
Malignant neoplasm of upper lip, vermilion border
A Phase I, Open-label, Dose-finding Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TRX-920 Oral Gel (10 mg and 30 mg) in Patients With Advanced Solid Tumors
-
Trial Applicant
TaiRx, Inc.
-
Sponsor
-
Trial scale
Taiwan Multiple Center
-
Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 王秀慈 Division of Hematology & Oncology
- 連銘瑜 Division of Hematology & Oncology
- Yu-Min Liao Division of Hematology & Oncology
- Chang-Fang Chiu Division of Hematology & Oncology
- Ming-Yu Lien Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Sheng-Yu Chen Division of Hematology & Oncology
- Jia-Ruey Tsai Division of Hematology & Oncology
- Kai-Ling Lee Division of Thoracic Medicine
- Huan-Tze Lin Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Yu-Min Yeh
Co-Principal Investigator
- Chia-Jui Yen Division of Hematology & Oncology
- 顏志傑 Division of Hematology & Oncology
- 劉奕廷 Division of Hematology & Oncology
- Shang-Hung Chen Division of Hematology & Oncology
- Chun-Hui Lee Division of Hematology & Oncology
- 蘇勇曄 Division of Hematology & Oncology
- Shang-Yin Wu Division of Hematology & Oncology
- 黃盈慈 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Advanced Solid Tumor
Objectives
主要目的：
‧ 鑑定最大耐受劑量 (MTD)及建議之臨床二期試驗劑量 (RP2D)
‧ 建立 TRX-920口服凝膠 之安全性及耐受性資料
次要目的：
‧ 確立服用 TRX-920口服凝膠後， SN38之藥物動力學資料
‧ 評估 TRX-920口服凝膠之初步抗癌效果
Test Drug
TRX-920 Oral Gel 10 mg & 30 mg
Active Ingredient
SN38
SN38
SN38
Dosage Form
oral syringe
Dosage
10 mg/g
30 mg/3 g
30 mg/3 g
Endpoints
‧最大耐受劑量(MTD)及建議之臨床二期試驗劑量(RP2D)
‧不良反應發生之頻率、類型、嚴重程度及與試驗藥品之關聯性
‧不良反應發生之頻率、類型、嚴重程度及與試驗藥品之關聯性
Inclution Criteria
(1) 簽署知情同意書。
(2) 經病理學及細胞學確診為晚期實體腫瘤，並且對標準療法無效，或無標準治療可供選擇之患者。
(3) 實體腫瘤必須依照RECIST 1.1準則可被測量與評估，已接受放射線治療的目標病灶將被視為無法測量。
(4) 年滿 18 歲之男性或女性。
(5) ECOG體能狀況評級為0至1級。
(6) 心電圖之QTcF間隔小於或等於480毫秒(msec)。(1) 具有UGT1A1*28或*6等位基因之純合性基因或兩者之複合雜合性基因（如：*28/*28, *6/*6, *6/*28）
(2) 具臨床意義的合併症，如不穩定型心絞痛、充血性心力衰竭（NYHA III或 IV 級）、無法控制的高血壓（最佳藥物治療下仍超過160/100 mmHg）、慢性阻塞性肺疾病 (COPD) 頻繁加重、難治性哮喘、發炎性腸道疾病或腸梗阻。
(3) 使用第一劑試驗藥物前6個月內曾發生急性心肌梗塞或腦中風(CVA)。
(4) 有中樞神經系統(CNS)轉移之病灶或惡性腫瘤引起之癲癇，已接受治療且中樞神經系統轉移之病灶穩定或無症狀除外。
(5) 過去12個月內有後天免疫缺乏症候群(AIDS)引發之機會性感染。
(6) B型肝炎感染者（B型肝炎表面抗原陽性）或C型肝炎感染者（C型肝炎抗陽性）。B型肝炎e抗原陰性、血清轉胺? ( ALT ) 數值正常且B型肝炎病毒核酸(HBV DNA) ＜ 2,000 IU/mL 之B型肝炎帶原者以及無法偵測到C型肝炎病毒核酸（HCV RNA）之C型肝炎帶原者除外。
(7) 骨髓、肝或腎功能不足，如下列範圍的實驗室檢驗數值：
絕對嗜中性球計數小於1,500/微升(μL)
血小板小於90,000/微升(μL)
血紅素小於9克/分升(g/dL)
總血清膽紅素超過標準值上限的1.5倍
血清中肝指數指標(AST或ALT)超過標準值上限的3倍；若有肝臟病灶，則為超過標準值上限的5倍
腎絲球過濾率＜ 60毫升/分鐘
(8) 先前治療或手術導致之毒性尚未緩解至一級(NCI CTCAE v5.0); 掉髮、皮膚色素過度沉澱、色素沉澱不足或其他經醫療顧問同意之二級毒性除外。
(9) 服用第一劑研究藥品前四週內曾接受重大手術或仍有手術後遺症。
(10) 在規定期間接受以下任一抗癌治療
a. 服用第一劑研究藥品前6週內曾使用過任何抗癌之放射性治療
b. 服用第一劑研究藥品前28天內曾接受過任何細胞毒性化療或治療後未逾5個半衰期者 (兩者中以為期較長者為準)。
c. 服用第一劑研究藥品前14天內曾接受過任何標靶治療或免疫療法
(11) 曾在使用預防性藥品的情況下仍對抗癌妥靜脈輸注濃縮液(Irinotecan/Campto® injection)產生過敏反應。
(12) 懷孕或哺正在哺乳的女性。
(13) 有生殖能力但不願於研究期間及服用最後一劑試驗藥物後一個月(女性)/三個月(男性)間使用有效避孕方式者。有效的避孕方式包括皮下埋植、注射避孕針、口服避孕藥、子宮內避孕器、完全停止性行為、絕育手術、或伴侶不孕等。
(14) 服用研究藥品前28天內曾接種活性減毒疫苗。
(15) 預期存活時間小於三個月。
(16) 有或曾有其他經試驗主持人判斷會影響受試者安全、使受試者無法配合試驗需求、或影響試驗結果判斷之其他狀況
(2) 經病理學及細胞學確診為晚期實體腫瘤，並且對標準療法無效，或無標準治療可供選擇之患者。
(3) 實體腫瘤必須依照RECIST 1.1準則可被測量與評估，已接受放射線治療的目標病灶將被視為無法測量。
(4) 年滿 18 歲之男性或女性。
(5) ECOG體能狀況評級為0至1級。
(6) 心電圖之QTcF間隔小於或等於480毫秒(msec)。(1) 具有UGT1A1*28或*6等位基因之純合性基因或兩者之複合雜合性基因（如：*28/*28, *6/*6, *6/*28）
(2) 具臨床意義的合併症，如不穩定型心絞痛、充血性心力衰竭（NYHA III或 IV 級）、無法控制的高血壓（最佳藥物治療下仍超過160/100 mmHg）、慢性阻塞性肺疾病 (COPD) 頻繁加重、難治性哮喘、發炎性腸道疾病或腸梗阻。
(3) 使用第一劑試驗藥物前6個月內曾發生急性心肌梗塞或腦中風(CVA)。
(4) 有中樞神經系統(CNS)轉移之病灶或惡性腫瘤引起之癲癇，已接受治療且中樞神經系統轉移之病灶穩定或無症狀除外。
(5) 過去12個月內有後天免疫缺乏症候群(AIDS)引發之機會性感染。
(6) B型肝炎感染者（B型肝炎表面抗原陽性）或C型肝炎感染者（C型肝炎抗陽性）。B型肝炎e抗原陰性、血清轉胺? ( ALT ) 數值正常且B型肝炎病毒核酸(HBV DNA) ＜ 2,000 IU/mL 之B型肝炎帶原者以及無法偵測到C型肝炎病毒核酸（HCV RNA）之C型肝炎帶原者除外。
(7) 骨髓、肝或腎功能不足，如下列範圍的實驗室檢驗數值：
絕對嗜中性球計數小於1,500/微升(μL)
血小板小於90,000/微升(μL)
血紅素小於9克/分升(g/dL)
總血清膽紅素超過標準值上限的1.5倍
血清中肝指數指標(AST或ALT)超過標準值上限的3倍；若有肝臟病灶，則為超過標準值上限的5倍
腎絲球過濾率＜ 60毫升/分鐘
(8) 先前治療或手術導致之毒性尚未緩解至一級(NCI CTCAE v5.0); 掉髮、皮膚色素過度沉澱、色素沉澱不足或其他經醫療顧問同意之二級毒性除外。
(9) 服用第一劑研究藥品前四週內曾接受重大手術或仍有手術後遺症。
(10) 在規定期間接受以下任一抗癌治療
a. 服用第一劑研究藥品前6週內曾使用過任何抗癌之放射性治療
b. 服用第一劑研究藥品前28天內曾接受過任何細胞毒性化療或治療後未逾5個半衰期者 (兩者中以為期較長者為準)。
c. 服用第一劑研究藥品前14天內曾接受過任何標靶治療或免疫療法
(11) 曾在使用預防性藥品的情況下仍對抗癌妥靜脈輸注濃縮液(Irinotecan/Campto® injection)產生過敏反應。
(12) 懷孕或哺正在哺乳的女性。
(13) 有生殖能力但不願於研究期間及服用最後一劑試驗藥物後一個月(女性)/三個月(男性)間使用有效避孕方式者。有效的避孕方式包括皮下埋植、注射避孕針、口服避孕藥、子宮內避孕器、完全停止性行為、絕育手術、或伴侶不孕等。
(14) 服用研究藥品前28天內曾接種活性減毒疫苗。
(15) 預期存活時間小於三個月。
(16) 有或曾有其他經試驗主持人判斷會影響受試者安全、使受試者無法配合試驗需求、或影響試驗結果判斷之其他狀況
Exclusion Criteria
Exclusion Criteria:
Patients with homozygous or compound heterozygous genotypes for UGT1A1*28 and *6 alleles (e.g., *28/*28, *6/*6, *6/*28).
Clinically significant comorbidity such as unstable angina, congestive heart failure (NYHA Grade III or IV), uncontrolled hypertension (>160/100 mmHg despite optimal medical treatment), chronic obstructive pulmonary disease (COPD) with frequent exacerbations, refractory asthma, inflammatory bowel disease or intestinal obstruction.
Acute myocardial infraction or cerebrovascular accident (CVA) within 6 months prior the first dose of study drug.
Central nervous system (CNS) metastasis or seizure disorder due to underlying malignancy except those who have been treated and have stable CNS metastases or are asymptomatic.
AIDS-defining opportunistic infections within the past 12 months.
HBV infection (positive HBsAg) except for carrier of inactive HBV as defined by negative HBeAg with normal ALT and HBV DNA < 2,000 IU/mL or HCV infection (positive anti-HCV antibody) except for those with undetectable HCV RNA.
Inadequate bone marrow reserve, hepatic or renal function as defined by any of the following laboratory values:
absolute neutrophil count (ANC) < 1500/µL
platelet count < 90,000/µL
hemoglobin < 9 g/dL
total bilirubin > 1.5*the upper limit of normal (ULN)
aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3*ULN if no hepatic metastases are present; > 5*ULN if hepatic metastases are present
Non-indexed eGFR < 60 mL/min (formula in Appendix 4)
Toxicities resulting from prior therapy or surgical procedures not yet resolved to ≤ NCI CTCAE v5.0 Grade 1 with the exception of alopecia, skin hyperpigmentation or hypopigmentation or grade 2 toxicity with prior approval of the Medical Monitor.
Major surgical procedures (as defined by Investigator) within 4 weeks prior to the first dose of study drug or any ongoing post-operative complications.
Receiving any radiotherapy within 3 months
Receiving any (investigational or approved) anti-cancer therapy (including chemotherapy or targeted therapy) within 28 days or 5 half-lives (whichever is longer) prior to the first dose of study drug
A history of apparent allergic reactions to irinotecan injection (dosed with prior treatment with prophylactic drug)
If female, is pregnant or breastfeeding
If men or women with childbearing potential, unwilling to use effective contraceptive methods during the study and for at least 3 months (men) or 1 month (women) after the last dose of study drug. Effective contraceptive methods include implants, injectables, combined oral contraceptives, intra-uterine devices (IUDs), sexual abstinence, surgical sterilization, or a partner who is sterile.
Receiving live attenuated vaccine within 28 days prior to the first dose of study drug.
Life expectancy < 3 months.
Other prior or ongoing condition(s) that, in the opinion of the investigator, could affect the safety of the subject, compromise the subject's ability to comply with the study requirements or impair the assessment of study results.
Patients with homozygous or compound heterozygous genotypes for UGT1A1*28 and *6 alleles (e.g., *28/*28, *6/*6, *6/*28).
Clinically significant comorbidity such as unstable angina, congestive heart failure (NYHA Grade III or IV), uncontrolled hypertension (>160/100 mmHg despite optimal medical treatment), chronic obstructive pulmonary disease (COPD) with frequent exacerbations, refractory asthma, inflammatory bowel disease or intestinal obstruction.
Acute myocardial infraction or cerebrovascular accident (CVA) within 6 months prior the first dose of study drug.
Central nervous system (CNS) metastasis or seizure disorder due to underlying malignancy except those who have been treated and have stable CNS metastases or are asymptomatic.
AIDS-defining opportunistic infections within the past 12 months.
HBV infection (positive HBsAg) except for carrier of inactive HBV as defined by negative HBeAg with normal ALT and HBV DNA < 2,000 IU/mL or HCV infection (positive anti-HCV antibody) except for those with undetectable HCV RNA.
Inadequate bone marrow reserve, hepatic or renal function as defined by any of the following laboratory values:
absolute neutrophil count (ANC) < 1500/µL
platelet count < 90,000/µL
hemoglobin < 9 g/dL
total bilirubin > 1.5*the upper limit of normal (ULN)
aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3*ULN if no hepatic metastases are present; > 5*ULN if hepatic metastases are present
Non-indexed eGFR < 60 mL/min (formula in Appendix 4)
Toxicities resulting from prior therapy or surgical procedures not yet resolved to ≤ NCI CTCAE v5.0 Grade 1 with the exception of alopecia, skin hyperpigmentation or hypopigmentation or grade 2 toxicity with prior approval of the Medical Monitor.
Major surgical procedures (as defined by Investigator) within 4 weeks prior to the first dose of study drug or any ongoing post-operative complications.
Receiving any radiotherapy within 3 months
Receiving any (investigational or approved) anti-cancer therapy (including chemotherapy or targeted therapy) within 28 days or 5 half-lives (whichever is longer) prior to the first dose of study drug
A history of apparent allergic reactions to irinotecan injection (dosed with prior treatment with prophylactic drug)
If female, is pregnant or breastfeeding
If men or women with childbearing potential, unwilling to use effective contraceptive methods during the study and for at least 3 months (men) or 1 month (women) after the last dose of study drug. Effective contraceptive methods include implants, injectables, combined oral contraceptives, intra-uterine devices (IUDs), sexual abstinence, surgical sterilization, or a partner who is sterile.
Receiving live attenuated vaccine within 28 days prior to the first dose of study drug.
Life expectancy < 3 months.
Other prior or ongoing condition(s) that, in the opinion of the investigator, could affect the safety of the subject, compromise the subject's ability to comply with the study requirements or impair the assessment of study results.
The Estimated Number of Participants
-
Taiwan
30 participants
-
Global
30 participants
