Clinical Trials List
Protocol NumberCVM-008
NCT Number(ClinicalTrials.gov Identfier)NCT05257590
Active
2022-01-01 - 2026-03-31
Phase II
Recruiting6
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 2, Open-Label Study of CVM-1118 in Combination With Nivolumab in Subjects With Unresectable Advanced Hepatocellular Carcinoma
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Trial Applicant
TaiRx, Inc.
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Sponsor
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Trial scale
Taiwan Multiple Center
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Update
2026/02/01
Investigators and Locations
Principal Investigator
Co-Principal Investigator
- 施怡倫 Division of Radiology
- JA-DER LIANG Division of General Internal Medicine
- Ming-Chih Ho Division of General Surgery
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 吳啟榮 Digestive System Department
- Rheun-Chuan Lee Division of Radiology
- I-Cheng Lee Digestive System Department
- San-Chi Chen Division of Hematology & Oncology
- 齊振達 Digestive System Department
- Yi-Ping Hung Division of Hematology & Oncology
- Chien-An Liu Division of Radiology
- 齊振達 Digestive System Department
- Pei-Chang Lee Digestive System Department
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 吳鋒 Division of Hematology & Oncology
- 陳義展 Division of General Surgery
- HANG HUONG LING Division of Hematology & Oncology
- 吳宗翰 Division of Hematology & Oncology
- 宋睿祥 Division of General Surgery
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Chia-Jui Yen
Co-Principal Investigator
- 邱彥程 Digestive System Department
- 趙盈瑞 Division of General Surgery
- Yih-Jyh Lin Division of General Surgery
- Yan-Shen Shan Division of General Surgery
- 簡世杰 Digestive System Department
- Pin-Nan Cheng Digestive System Department
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- JA-DER LIANG Division of General Internal Medicine
- 施怡倫 Division of Radiology
- Ming-Chih Ho Division of General Surgery
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Hepatocellular Carcinoma
Objectives
Primary Objective: To evaluate the efficacy of CVM-1118 in combination with nivolumab in patients with advanced hepatocellular carcinoma.
Secondary Objectives:
1. To evaluate the safety of CVM-1118 and nivolumab in patients with advanced hepatocellular carcinoma.
2. To establish the pharmacokinetic parameters of CVM-1118 and its metabolite CVM-1125 after combination with nivolumab.
3. To establish the pharmacodynamics of CVM-1118 and its metabolite CVM-1125 after combination with nivolumab.
Test Drug
CVM-1118 膠囊 (又名 CVM-1118 速放膠囊 )
Active Ingredient
CVM-1118
Dosage Form
速放劑型膠囊
Dosage
50
Endpoints
1. Primary endpoint: Objective response rate (ORR: complete remission (CR) + partial remission (PR)) 24 weeks (6 months) after the last subject received the first dose of CVM-1118; measured using mRECIST.
2. Secondary Assessment Indicators:
Efficacy Assessment Indicators:
(1) Objective Response Rate (ORR); RECIST 1.1 was used as the assessment standard.
(2) Duration of Response (DoR)
(3) Progression-Free Survival (PFS)
(4) Time to Tumor Progression (TTP)
(5) Overall Survival (OS)
(6) Disease Control Rate (DCR = Complete Response (CR) + Partial Response (PR) + Stable Disease (SD))
Safety Assessment Indicators:
(1) Adverse Events
(2) Serious Adverse Events
(3) Incidence of Abnormal Laboratory Test Values
(4) Incidence of Abnormal Electrocardiogram Values (e.g., QTcF interval)
(5) Changes in Physical Examination Values
(6) Changes in Vital Sign Values
Pharmacokinetic Assessment Indicators: The following values were monitored in the first and second trial cycles for CVM-1118 and its metabolite CVM-1125: Cmax, Cmin (trough), Tmax, AUC, T1/2, V/F, CL/F
Pharmacokinetic assessment indicators: Assess the correlation between pharmacokinetic values (AUC and Cmax) and the efficacy and safety assessment indicators of this trial.
2. Secondary Assessment Indicators:
Efficacy Assessment Indicators:
(1) Objective Response Rate (ORR); RECIST 1.1 was used as the assessment standard.
(2) Duration of Response (DoR)
(3) Progression-Free Survival (PFS)
(4) Time to Tumor Progression (TTP)
(5) Overall Survival (OS)
(6) Disease Control Rate (DCR = Complete Response (CR) + Partial Response (PR) + Stable Disease (SD))
Safety Assessment Indicators:
(1) Adverse Events
(2) Serious Adverse Events
(3) Incidence of Abnormal Laboratory Test Values
(4) Incidence of Abnormal Electrocardiogram Values (e.g., QTcF interval)
(5) Changes in Physical Examination Values
(6) Changes in Vital Sign Values
Pharmacokinetic Assessment Indicators: The following values were monitored in the first and second trial cycles for CVM-1118 and its metabolite CVM-1125: Cmax, Cmin (trough), Tmax, AUC, T1/2, V/F, CL/F
Pharmacokinetic assessment indicators: Assess the correlation between pharmacokinetic values (AUC and Cmax) and the efficacy and safety assessment indicators of this trial.
Inclution Criteria
Inclusion Criteria:
Age 18+ (20+ for subjects in Taiwan)
Diagnosis of hepatocellular carcinoma
Pathologically or cytologically-confirmed or clinically diagnosed in accordance with American Association for the Study of Liver Diseases (AASLD) criteria (i.e., radiologic imaging with cross-sectional multiphasic contrast CT or MRI showing a ≥ 1 cm liver lesion)
Subjects with advanced-stage, unresectable hepatocellular carcinoma that is not appropriate for potentially curable therapy who have progressed from, been intolerant of prior systemic anti-cancer therapies (e.g., sorafenib, lenvatinib, atezolizumab in combination with bevacizumab).
Barcelona Clinic Liver Cancer (BCLC) stage B not appropriate for or with disease progression after local regional therapy, or BCLC stage C
Child-Pugh liver function class A
Measurable disease (per mRECIST)
ECOG performance status of 0 to 1
Adequate laboratory parameters including:
AST and ALT ≤ 3.0 x ULN (≤ 5.0 x ULN if due to liver involvement)
Total serum bilirubin ≤ 2.0 x ULN (≤ 3.0 x ULN for subjects with documented Gilbert's syndrome)
ANC ≥1500/µL
Platelets ≥ 90,000/µL
HGB ≥ 9.0 g/dL
Serum creatinine clearance of ≥ 50 mL/min based on Cockcroft-Gault formula
Serum albumin ≥ 2.8 gm/dL
INR ≤ 2.3
PT/aPTT ≤ 1.2 x ULN
QTcF ≤ 480 msec
Subjects are eligible to enroll if they have HBV-, or HCV-HCC, defined as follows:
Chronic HBV infection as evidenced by detectable HBV DNA or HBsAg. Subjects with chronic HBV infection must be on antiviral therapy and have HBV DNA <500 IU/mL. If not on an antiviral therapy at screening, then subjects must be willing to start the antiviral therapy at the time of consent.
Active or resolved HCV infection as evidenced by detectable HCV RNA or antibody.
Age 18+ (20+ for subjects in Taiwan)
Diagnosis of hepatocellular carcinoma
Pathologically or cytologically-confirmed or clinically diagnosed in accordance with American Association for the Study of Liver Diseases (AASLD) criteria (i.e., radiologic imaging with cross-sectional multiphasic contrast CT or MRI showing a ≥ 1 cm liver lesion)
Subjects with advanced-stage, unresectable hepatocellular carcinoma that is not appropriate for potentially curable therapy who have progressed from, been intolerant of prior systemic anti-cancer therapies (e.g., sorafenib, lenvatinib, atezolizumab in combination with bevacizumab).
Barcelona Clinic Liver Cancer (BCLC) stage B not appropriate for or with disease progression after local regional therapy, or BCLC stage C
Child-Pugh liver function class A
Measurable disease (per mRECIST)
ECOG performance status of 0 to 1
Adequate laboratory parameters including:
AST and ALT ≤ 3.0 x ULN (≤ 5.0 x ULN if due to liver involvement)
Total serum bilirubin ≤ 2.0 x ULN (≤ 3.0 x ULN for subjects with documented Gilbert's syndrome)
ANC ≥1500/µL
Platelets ≥ 90,000/µL
HGB ≥ 9.0 g/dL
Serum creatinine clearance of ≥ 50 mL/min based on Cockcroft-Gault formula
Serum albumin ≥ 2.8 gm/dL
INR ≤ 2.3
PT/aPTT ≤ 1.2 x ULN
QTcF ≤ 480 msec
Subjects are eligible to enroll if they have HBV-, or HCV-HCC, defined as follows:
Chronic HBV infection as evidenced by detectable HBV DNA or HBsAg. Subjects with chronic HBV infection must be on antiviral therapy and have HBV DNA <500 IU/mL. If not on an antiviral therapy at screening, then subjects must be willing to start the antiviral therapy at the time of consent.
Active or resolved HCV infection as evidenced by detectable HCV RNA or antibody.
Exclusion Criteria
Exclusion Criteria:
HCC with portal vein invasion at the main portal branch (Vp4)
Known history of esophageal varices or gastrointestinal bleeding within the past 3 months
Prior immunotherapy for hepatoma
≤ 7 days from prior limited field palliative irradiation therapy and C1D1
≤ 28 days from prior irradiation therapy and C1D1
≤ 14 days (or 5 half-lives) from prior systemic anticancer therapy and C1D1
≤ 28 days from local regional therapy (e.g., trans-arterial embolization, radiofrequency ablation) and C1D1
Presence of other active cancer(s) likely to require treatment in the next two (2) years or likely to impact the assessment of any study endpoints
Active bacterial or fungal infection(s) requiring systemic therapy within 7 days prior to C1D1
Known CNS metastases
Known history of HIV infection
Females who are currently pregnant or breast-feeding
Known gastrointestinal disease that may significantly alter the absorption of oral medications
Psychiatric illness or social situation that would interfere with compliance with study requirements
History of clinically significant cardiovascular abnormalities
HCC with portal vein invasion at the main portal branch (Vp4)
Known history of esophageal varices or gastrointestinal bleeding within the past 3 months
Prior immunotherapy for hepatoma
≤ 7 days from prior limited field palliative irradiation therapy and C1D1
≤ 28 days from prior irradiation therapy and C1D1
≤ 14 days (or 5 half-lives) from prior systemic anticancer therapy and C1D1
≤ 28 days from local regional therapy (e.g., trans-arterial embolization, radiofrequency ablation) and C1D1
Presence of other active cancer(s) likely to require treatment in the next two (2) years or likely to impact the assessment of any study endpoints
Active bacterial or fungal infection(s) requiring systemic therapy within 7 days prior to C1D1
Known CNS metastases
Known history of HIV infection
Females who are currently pregnant or breast-feeding
Known gastrointestinal disease that may significantly alter the absorption of oral medications
Psychiatric illness or social situation that would interfere with compliance with study requirements
History of clinically significant cardiovascular abnormalities
The Estimated Number of Participants
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Taiwan
106 participants
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Global
106 participants
