計劃書編號SNOF-001
NCT Number(ClinicalTrials.gov Identfier)NCT06143774
試驗執行中
2023-09-30 - 2026-06-30
Phase I
召募中3
ICD-10C00.0
上唇外側惡性腫瘤
ICD-10Z51.12
來院接受抗腫瘤免疫療法
ICD-9140.0
上唇紅緣惡性腫瘤
癌症用藥TRX-920口服凝膠(10毫克及30毫克)用於晚期實體腫瘤患者以評估藥物安全性、耐受性、藥物動力學及初步效果之臨床一期劑量探索性試驗
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試驗申請者
台睿生物科技股份有限公司
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試驗委託 / 贊助單位名稱
台睿生物科技股份有限公司
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臨床試驗規模
台灣多中心
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更新日期
2026/02/01
試驗主持人及試驗醫院
適應症
晚期實體腫瘤
試驗目的
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
藥品名稱
預充填式注射劑
主成份
SN38
SN38
SN38
劑型
oral syringe
劑量
10 mg/g
30 mg/3 g
30 mg/3 g
評估指標
•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
主要納入條件
(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)。
(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)。
主要排除條件
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.
試驗計畫預計收納受試者人數
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台灣人數
30 人
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全球人數
30 人
