Clinical Trials List
Protocol NumberFENG-NAV-202
Not yet recruiting
2025-11-19 - 2030-06-30
Phase II
Recruiting10
ICD-10C57.4
Malignant neoplasm of uterine adnexa, unspecified
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9183.8
Malignant neoplasm of other specified sites of uterine adnexa
A phase 2 open-label trial of navicixizumab monotherapy in patients with platinum-resistant epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
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Sponsor
Hevist International Pharmaceutical Co., Ltd.
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Trial scale
Taiwan Multiple Center
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Update
2026/07/02
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Yi-Jen Chen Division of Obstetrics & Gynecology
- Huann-Cheng Horng Division of Obstetrics & Gynecology
- Yen-Hou Chang Division of Obstetrics & Gynecology
- 楊思婷 Division of Obstetrics & Gynecology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 張正昌 Division of Obstetrics & Gynecology
- Wei-Chun Chang Division of Obstetrics & Gynecology
- Wu-Chou Lin Division of Obstetrics & Gynecology
- Yin-Yi Chang Division of Obstetrics & Gynecology
- 宋鈺雯 Division of Obstetrics & Gynecology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 許世典 Division of Obstetrics & Gynecology
- 孫珞 Division of Obstetrics & Gynecology
- 黃曉峰 Division of Obstetrics & Gynecology
- 石宇翔 Division of Obstetrics & Gynecology
- 劉芝谷 Division of Obstetrics & Gynecology
- 陳蓉宣
- 呂亭芳 Division of Obstetrics & Gynecology
- 王韶靖 Division of Obstetrics & Gynecology
- 范鈞婷 Division of Obstetrics & Gynecology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Tzeon-jye Chiou Division of Hematology & Oncology
- Chia-Lun Chang Division of Hematology & Oncology
- Tzu-Yao Liao Division of Hematology & Oncology
- 賴斯斌 Division of Obstetrics & Gynecology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
周宏學
Co-Principal Investigator
- Ting-Chang Chang Division of Obstetrics & Gynecology
- Chyong-Huey Lai Division of Obstetrics & Gynecology
- Cheng-Tao Lin Division of Obstetrics & Gynecology
- 黃寬仁 Division of Obstetrics & Gynecology
- Huei-Jean Huang Division of Obstetrics & Gynecology
- Angel Chao Division of Obstetrics & Gynecology
- Min-Yu Chen Division of Obstetrics & Gynecology
- 黃彥綾 Division of Radiology
- 陳威君 Division of Obstetrics & Gynecology
- 容世明 Division of Others -
- HSIU-JUNG TUNG Division of Obstetrics & Gynecology
- 張淑涵 Division of Obstetrics & Gynecology
- 張宸邠 Division of Obstetrics & Gynecology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Platinum-based therapy-resistant epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer
Objectives
Primary Objectives:
• Evaluate the overall treatment response to navicixizumab monotherapy in patients with platinum-resistant epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer, stratified by biomarker status as determined by the Xerna™ TME assay.
Secondary Objectives:
• Evaluate the safety and tolerability of navicixizumab infusion in patients with platinum-resistant epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
• Evaluate other antitumor activity parameters of navicixizumab monotherapy in patients with platinum-resistant epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer, stratified by biomarker status as determined by the Xerna™ TME assay and/or prior use of bevacizumab (or a biosimilar).
Exploratory Objectives:
• Evaluate the Xerna™ TME assay in the study population. Prevalence of Panel Biomarker Positive Subjects
• Calculate the predictive probability of Xerna™ TME biomarkers in subjects with platinum-based therapy-resistant/refractory epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
Test Drug
Navicixizumab
Active Ingredient
Navicixizumab
Dosage Form
Injectable
Dosage
10mg/mL, 10mL solution for infusion (100 mg/vial)
Endpoints
ORR across all population groups, as well as between biomarker-positive and biomarker-negative groups differentiated by the Xerna™ TME assay, is defined as the proportion of participants who achieved a confirmed complete response (CR) or partial response (PR) as determined by RECIST v 1.1 (assessed by the trial administrator).
Inclution Criteria
1) Subjects must provide a consent form before any trial procedure.
2) Patients must be ≥ 18 years old at the time of screening.
3) Subjects must have pathologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, and consist of one of the following histological subtypes:
• Adenocarcinoma (unspecified)
• Leucocyte adenocarcinoma
• Endometrial adenocarcinoma
• Malignant Brunnéroch tumor
• Mixed epithelial carcinoma
• Malignant mixed Müllerian duct tumor
• Serous adenocarcinoma
• Transitional cell carcinoma
• Undifferentiated cell carcinoma
• Exception: Subjects with mucinous carcinoma or low-grade serous carcinoma are not eligible.
4) Subjects must be identified as resistant to platinum-based therapy, defined as progression within 6 months of completion of platinum-based therapy.
5) Subjects must have previously received ≥ Two to no more than five standard therapies:
• Adjuvant/lead adjuvant therapy counts as one therapy.
• Maintenance therapy (e.g., bevacizumab, poly(ADP-ribose) polymerase [PARP] inhibitors will be considered part of first-line therapy [i.e., not counted independently]).
• Therapy adjustments due to toxicity without progression will be considered part of the same first-line therapy [i.e., not counted independently].
• Hormone therapy will be considered another first-line therapy unless administered as maintenance therapy.
• Subjects known to have breast cancer gene (BRCA) -1 or -2 mutations should have previously received PARP inhibitor therapy.
6) Subjects must be willing and able to provide stockpiled FFPE or fresh core needle tumor samples for Xerna™ prior to trial treatment. Biomarker status was determined using TME assay.
7) Subjects had a measurable disease as defined in RECIST version 1.1. Lesions previously exposed to radiation were considered measurable if disease progression had been clearly demonstrated since radiation exposure.
8) Subjects had an East Coast Cancer Clinical Research Partnership (ECOG) performance status of 0 to 1.
9) Subjects had adequate organ function, defined by the following laboratory test values obtained within 14 days prior to administration of the first dose of investigational drug:
Parameter Criteria
Heme ≥ 9.0 g/dL
Absolute neutrophil count ≥ 1500/mm³ (1.5 x 10⁹/L)
Platelet count ≥ 100,000/mm³ (100 x 10⁹/L)
Total serum bilirubin ≤ 1.5 mg/dL
AST/SGOT ≤ 3.0 x ULN (subject to institutional limitations)
≤ 5.0 x ULN (If liver metastasis is confirmed)
ALT/SGPT ≤ 3.0 x ULN (subject to institutional limitations)
≤ 5.0 x ULN (if liver metastasis is confirmed)
Serum creatinine ≤ 1.5 x mg/dL
Urine test strips - Urine test strips are used to detect proteinuria < 2+. Subjects with proteinuria ≥ 2+ in baseline test strip analysis should undergo 24-hour urine collection and must demonstrate that 24-hour urine protein ≤ 1 g.
(Abbreviations: ALT/SGPT = alanine transaminase; aPTT = activated partial thromboplastin time; AST/SGOT = aspartate transaminase;
INR = International Normalized Ratio; ULN = Upper limit of normal.
a Subjects with grade 1 hyperbilirubinemia solely due to a medical diagnosis of Gilbert's syndrome may be included.
b If the subject is receiving anticoagulant therapy, prothrombin time/aPTT...) It should fall within the therapeutic scope of its intended use. "") 10) Subjects must discontinue other anticancer interventions before Day 1 of Cycle 1 (C1D1), as follows: (a) cytotoxic chemotherapy for at least 14 days; (b) biological therapies (e.g., antibodies) or investigational drugs within 5 half-lives or 28 days (whichever occurs less); (c) non-myelosuppressants for at least 14 days; (d) radiotherapy for at least 28 days, except for limited-field palliative radiotherapy targeting non-target lesions, which may be completed at least 14 days before C1D1, and (e) 11) Participants of fertility must have a negative serum pregnancy test result at screening.
12) Participants of fertility must agree to follow instructions for highly effective contraception during the trial and for 6 months after treatment. (Infertility is defined as surgical infertility (history of bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) or postmenopause (defined as ≥12 consecutive months of amenorrhea prior to screening without other medical cause).
13) Participants must be willing and able to comply with all trial protocol requirements.
2) Patients must be ≥ 18 years old at the time of screening.
3) Subjects must have pathologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, and consist of one of the following histological subtypes:
• Adenocarcinoma (unspecified)
• Leucocyte adenocarcinoma
• Endometrial adenocarcinoma
• Malignant Brunnéroch tumor
• Mixed epithelial carcinoma
• Malignant mixed Müllerian duct tumor
• Serous adenocarcinoma
• Transitional cell carcinoma
• Undifferentiated cell carcinoma
• Exception: Subjects with mucinous carcinoma or low-grade serous carcinoma are not eligible.
4) Subjects must be identified as resistant to platinum-based therapy, defined as progression within 6 months of completion of platinum-based therapy.
5) Subjects must have previously received ≥ Two to no more than five standard therapies:
• Adjuvant/lead adjuvant therapy counts as one therapy.
• Maintenance therapy (e.g., bevacizumab, poly(ADP-ribose) polymerase [PARP] inhibitors will be considered part of first-line therapy [i.e., not counted independently]).
• Therapy adjustments due to toxicity without progression will be considered part of the same first-line therapy [i.e., not counted independently].
• Hormone therapy will be considered another first-line therapy unless administered as maintenance therapy.
• Subjects known to have breast cancer gene (BRCA) -1 or -2 mutations should have previously received PARP inhibitor therapy.
6) Subjects must be willing and able to provide stockpiled FFPE or fresh core needle tumor samples for Xerna™ prior to trial treatment. Biomarker status was determined using TME assay.
7) Subjects had a measurable disease as defined in RECIST version 1.1. Lesions previously exposed to radiation were considered measurable if disease progression had been clearly demonstrated since radiation exposure.
8) Subjects had an East Coast Cancer Clinical Research Partnership (ECOG) performance status of 0 to 1.
9) Subjects had adequate organ function, defined by the following laboratory test values obtained within 14 days prior to administration of the first dose of investigational drug:
Parameter Criteria
Heme ≥ 9.0 g/dL
Absolute neutrophil count ≥ 1500/mm³ (1.5 x 10⁹/L)
Platelet count ≥ 100,000/mm³ (100 x 10⁹/L)
Total serum bilirubin ≤ 1.5 mg/dL
AST/SGOT ≤ 3.0 x ULN (subject to institutional limitations)
≤ 5.0 x ULN (If liver metastasis is confirmed)
ALT/SGPT ≤ 3.0 x ULN (subject to institutional limitations)
≤ 5.0 x ULN (if liver metastasis is confirmed)
Serum creatinine ≤ 1.5 x mg/dL
Urine test strips - Urine test strips are used to detect proteinuria < 2+. Subjects with proteinuria ≥ 2+ in baseline test strip analysis should undergo 24-hour urine collection and must demonstrate that 24-hour urine protein ≤ 1 g.
(Abbreviations: ALT/SGPT = alanine transaminase; aPTT = activated partial thromboplastin time; AST/SGOT = aspartate transaminase;
INR = International Normalized Ratio; ULN = Upper limit of normal.
a Subjects with grade 1 hyperbilirubinemia solely due to a medical diagnosis of Gilbert's syndrome may be included.
b If the subject is receiving anticoagulant therapy, prothrombin time/aPTT...) It should fall within the therapeutic scope of its intended use. "") 10) Subjects must discontinue other anticancer interventions before Day 1 of Cycle 1 (C1D1), as follows: (a) cytotoxic chemotherapy for at least 14 days; (b) biological therapies (e.g., antibodies) or investigational drugs within 5 half-lives or 28 days (whichever occurs less); (c) non-myelosuppressants for at least 14 days; (d) radiotherapy for at least 28 days, except for limited-field palliative radiotherapy targeting non-target lesions, which may be completed at least 14 days before C1D1, and (e) 11) Participants of fertility must have a negative serum pregnancy test result at screening.
12) Participants of fertility must agree to follow instructions for highly effective contraception during the trial and for 6 months after treatment. (Infertility is defined as surgical infertility (history of bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) or postmenopause (defined as ≥12 consecutive months of amenorrhea prior to screening without other medical cause).
13) Participants must be willing and able to comply with all trial protocol requirements.
Exclusion Criteria
1) Subjects must have any of the following cardiac-related conditions:
• Angina, unstable angina, myocardial infarction, cardiomyopathy, clinically significant arrhythmia, or symptomatic heart failure of NYHA class II-IV severity (Appendix 1) within 6 months prior to C1D1.
• History of stroke or transient ischemic attack within 6 months prior to C1D1.
• Baseline B-type natriuretic peptide (BNP) value > or N-terminal proBNP (NTproBNP) value exceeding the age-adjusted normal range.
• Left ventricular ejection fraction < 50%.
• Tricuspid regurgitation peak velocity on Doppler echocardiography > 3.0 m/s.
• Clinically significant ECG abnormalities as assessed by the trial administrator.
2) Subjects' blood pressure (BP) > 140/90 mmHg. Subjects taking antihypertensive medication must have their BP controlled to ≤ 140/90 mmHg with ≤ 2 medications. mmHg. Note: Fixed-dose combination antihypertensive therapy formulations should be considered as two drugs.
3) Subjects are known to have untreated, active, or uncontrolled brain metastases.
Exception: Subjects with stable CNS disease, no evidence of worsening in at least 4 weeks prior to receiving the first dose of trial treatment, recovery of any neurological symptoms to baseline, no new or expanding evidence of brain metastases, and who have not used steroids for at least 14 days prior to the first dose of trial treatment.
4) During or after completion of the first platinum-based treatment cycle. 5) Subjects with ovarian cancer whose disease has worsened within the past week.
6) Subjects with meningeal disease.
7) Subjects with other known malignancies that are worsening or require active therapy within 2 years prior to receiving the first dose of the investigational drug.
Exceptions: Malignancies with negligible risk of metastasis or death, including basal cell carcinoma of the skin, squamous cell carcinoma in situ (e.g., breast cancer, cervical cancer in situ).
8) Subjects with non-epithelial ovarian cancer or low-grade malignant tumors (i.e., marginal tumors).
9) Subjects with a history of bowel obstruction or bowel obstruction (including subobstructive disease; related to pre-existing conditions) within 6 months prior to the first dose of the investigational drug, or a history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess.
Exceptions may be considered at the discretion of the trial administrator: Rectosigmoid colon invasion shown on pelvic examination or evidence of bowel invasion on computed tomography (CT) scan, without clinical symptoms of bowel obstruction.
10) Subjects with a known hypersensitivity to any component of any investigational drug or any of its excipients, as determined by the trial administrator. This suggests a higher risk of severe allergic reactions during treatment.
10) The subject received a blood product (including platelets or erythrocytes) or recombinant erythropoietin transfusion within 14 days prior to the first dose of the trial treatment.
11) The subject received a community-stimulating factor (including granulocyte colony-stimulating factor, granulocyte-macrophage colony-stimulating factor) within 14 days prior to the first dose of the trial treatment.
12) The subject is known to have a clinically significant bleeding disorder.
13) The subject requires anticoagulation for any reason. Treatment.
Note: Prophylactic use of low-dose aspirin and/or nonsteroidal anti-inflammatory drugs (NSAIDs) is permitted.
14) Subjects who have undergone major surgery or severe trauma within 28 days prior to C1D1, or who are expected to undergo major surgery during the trial.
15) Pregnant or breastfeeding women.
16) Active, uncontrolled bacterial, viral, or fungal infections requiring intravenous systemic therapy.
17) Subjects known to have HIV, hepatitis B, or hepatitis C infection.
Exception: Subjects known to have no prior history of HIV infection. Subjects with a history of HBV infection, who have been vaccinated against hepatitis B, and for whom evidence shows only a positive hepatitis B surface antigen antibody test are eligible to participate in the study.
Subjects with HBV/HCV infection who have already received treatment and whose HBV DNA/HCV RNA is undetectable according to the research center's institutional standards may participate in the study upon approval from medical surveillance.
18) Subjects who have experienced toxicities from previous treatment and have not recovered to ≤ Grade 1 prior to the first dose of trial treatment.
Exception: Subjects with stable chronic adverse events (≤ Grade 2) or adverse events expected to resolve (e.g., neuropathy and hair loss) may be included upon approval from medical surveillance.
• Angina, unstable angina, myocardial infarction, cardiomyopathy, clinically significant arrhythmia, or symptomatic heart failure of NYHA class II-IV severity (Appendix 1) within 6 months prior to C1D1.
• History of stroke or transient ischemic attack within 6 months prior to C1D1.
• Baseline B-type natriuretic peptide (BNP) value > or N-terminal proBNP (NTproBNP) value exceeding the age-adjusted normal range.
• Left ventricular ejection fraction < 50%.
• Tricuspid regurgitation peak velocity on Doppler echocardiography > 3.0 m/s.
• Clinically significant ECG abnormalities as assessed by the trial administrator.
2) Subjects' blood pressure (BP) > 140/90 mmHg. Subjects taking antihypertensive medication must have their BP controlled to ≤ 140/90 mmHg with ≤ 2 medications. mmHg. Note: Fixed-dose combination antihypertensive therapy formulations should be considered as two drugs.
3) Subjects are known to have untreated, active, or uncontrolled brain metastases.
Exception: Subjects with stable CNS disease, no evidence of worsening in at least 4 weeks prior to receiving the first dose of trial treatment, recovery of any neurological symptoms to baseline, no new or expanding evidence of brain metastases, and who have not used steroids for at least 14 days prior to the first dose of trial treatment.
4) During or after completion of the first platinum-based treatment cycle. 5) Subjects with ovarian cancer whose disease has worsened within the past week.
6) Subjects with meningeal disease.
7) Subjects with other known malignancies that are worsening or require active therapy within 2 years prior to receiving the first dose of the investigational drug.
Exceptions: Malignancies with negligible risk of metastasis or death, including basal cell carcinoma of the skin, squamous cell carcinoma in situ (e.g., breast cancer, cervical cancer in situ).
8) Subjects with non-epithelial ovarian cancer or low-grade malignant tumors (i.e., marginal tumors).
9) Subjects with a history of bowel obstruction or bowel obstruction (including subobstructive disease; related to pre-existing conditions) within 6 months prior to the first dose of the investigational drug, or a history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess.
Exceptions may be considered at the discretion of the trial administrator: Rectosigmoid colon invasion shown on pelvic examination or evidence of bowel invasion on computed tomography (CT) scan, without clinical symptoms of bowel obstruction.
10) Subjects with a known hypersensitivity to any component of any investigational drug or any of its excipients, as determined by the trial administrator. This suggests a higher risk of severe allergic reactions during treatment.
10) The subject received a blood product (including platelets or erythrocytes) or recombinant erythropoietin transfusion within 14 days prior to the first dose of the trial treatment.
11) The subject received a community-stimulating factor (including granulocyte colony-stimulating factor, granulocyte-macrophage colony-stimulating factor) within 14 days prior to the first dose of the trial treatment.
12) The subject is known to have a clinically significant bleeding disorder.
13) The subject requires anticoagulation for any reason. Treatment.
Note: Prophylactic use of low-dose aspirin and/or nonsteroidal anti-inflammatory drugs (NSAIDs) is permitted.
14) Subjects who have undergone major surgery or severe trauma within 28 days prior to C1D1, or who are expected to undergo major surgery during the trial.
15) Pregnant or breastfeeding women.
16) Active, uncontrolled bacterial, viral, or fungal infections requiring intravenous systemic therapy.
17) Subjects known to have HIV, hepatitis B, or hepatitis C infection.
Exception: Subjects known to have no prior history of HIV infection. Subjects with a history of HBV infection, who have been vaccinated against hepatitis B, and for whom evidence shows only a positive hepatitis B surface antigen antibody test are eligible to participate in the study.
Subjects with HBV/HCV infection who have already received treatment and whose HBV DNA/HCV RNA is undetectable according to the research center's institutional standards may participate in the study upon approval from medical surveillance.
18) Subjects who have experienced toxicities from previous treatment and have not recovered to ≤ Grade 1 prior to the first dose of trial treatment.
Exception: Subjects with stable chronic adverse events (≤ Grade 2) or adverse events expected to resolve (e.g., neuropathy and hair loss) may be included upon approval from medical surveillance.
The Estimated Number of Participants
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Taiwan
60 participants
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Global
60 participants
