Clinical Trials List
Protocol NumberGNX-001
NCT Number(ClinicalTrials.gov Identfier)NCT04250597
2020-08-01 - 2024-11-29
Phase I
Recruiting2
A Phase I Study of GNX102 in patients with Advanced Solid Tumors
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Trial Applicant
Linical
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Sponsor
GlycoNex, Inc.
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Chang-Fang Chiu Division of Hematology & Oncology
- Ching-Chan Lin Division of Hematology & Oncology
- Che-Hung Lin Division of Hematology & Oncology
- Chi-Ching Chen Division of Hematology & Oncology
- Chen-Yuan Lin Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Shang-Yin Wu Division of Hematology & Oncology
- Chien-Jui Huang Digestive System Department
- Wen-Pin Su Division of Hematology & Oncology
- 劉奕廷 Division of Hematology & Oncology
- 趙盈瑞 Division of General Surgery
- Yu-Min Yeh Division of Hematology & Oncology
- 楊舜如 Division of Hematology & Oncology
- Wei-Pang Chung Division of Hematology & Oncology
- Yan-Shen Shan Division of General Surgery
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Advanced Solid Tumors
Objectives
GNX-001 is an open-label, phase 1, multicenter, dose-escalation and expansion study of GNX102 infused every 21 days. Approximately 30 patients may be enrolled in the dose escalation portion of this study. Once the MTD or recommended phase 2 dose (RP2D) has been identified, up to 15 additional patients may be enrolled in one or two expansion cohort(s) at one or two dose levels recommended by the Safety Review Committee) to confirm the safety profile of the RP2D and provide additional information on anti-tumor activity.
Test Drug
GNX102
Active Ingredient
GNX102 (humanized monoclonal antibody)
Dosage Form
Vial
Dosage
30 mg/mL, 10 mL/vial
Endpoints
Maximum tolerated dose (MTD)
Inclution Criteria
1.Age ≥ 18 years.
2.Patients with histologically confirmed solid tumors with a likelihood of expression of GNX102 targeted antigens, which are limited to:
-colorectal
-hepatocellular
-non-small cell lung
-gastric
-breast
-bladder
-pancreatic
-melanoma (cutaneous, acral, or mucosal)
-esophageal
-prostate
-ovarian
-cervical
-epithelial uterine cancers.
3.Patient has a paraffin block of non-necrotic tumor tissue available for immunohistochemistry (IHC) analyses, to be shipped prior to initiation of treatment. Processing includes an option to send formalin-fixed paraffin embedded slides [FFPE] slides if a tumor block is not available.
4.Advanced, unresectable (local, regionally, recurrent not amenable to curative therapy) or metastatic disease that has no standard therapeutic option with a proven clinical benefit, are intolerant to or have refused all standard of care options with demonstrated clinical benefit.
5.Expansion Phase only: patient has measurable disease per RECIST v 1.1 criteria.
6.ECOG performance status of 0 or 1.
7.Baseline QTC interval of ≤ 480 msec using Frederica's formula.
8.Acceptable liver function:
-Bilirubin ≤ 1.5 times upper limit of normal
-AST (SGOT) and ALT (SGPT) ≤ 3 times upper limit of normal. If liver metastases are present, then ≤ 5 x ULN is allowed, and
-Serum albumin ≥ 2.5 g/dL.
9.Acceptable renal function, defined as calculated creatinine clearance > 30 mL/min per institution laboratory values.
10.Acceptable hematologic status:
-Hemoglobin ≥ 8 g/dL (no packed red blood cell [PRBC] transfusions allowed within 2 weeks)
-Absolute neutrophil count (ANC) ≥ 1500 cells/mm^3 or ≥ 1.5 x 10^9/L
-Platelet count ≥ 100,000 platelets/mm^3 or ≥ 100 x 10^9/L, and
-Absolute reticulocyte count (x10^9/L) < ULN.
11.Serum haptoglobin (mg/dL) > LLN.
12.Acceptable coagulation status with fibrinogen, above LLN; PT/INR and PTT ≤ 1.5 times upper limit of normal (may be on a stable dose of coumadin with stable INR in the therapeutic range).
13.Life expectancy of at least 3 months.
14.Signed IRB-approved informed consent.
15.Able and willing to comply with the protocol for the duration of the study, including undergoing treatment and scheduled visits and examinations.
16.A negative serum pregnancy test, if female of child-bearing potential.
17.For men and women of child-bearing potential, agreement to the use of at least 1 highly effective contraceptive method(s) during the study and in the 3 months following the last dose of GNX102.
2.Patients with histologically confirmed solid tumors with a likelihood of expression of GNX102 targeted antigens, which are limited to:
-colorectal
-hepatocellular
-non-small cell lung
-gastric
-breast
-bladder
-pancreatic
-melanoma (cutaneous, acral, or mucosal)
-esophageal
-prostate
-ovarian
-cervical
-epithelial uterine cancers.
3.Patient has a paraffin block of non-necrotic tumor tissue available for immunohistochemistry (IHC) analyses, to be shipped prior to initiation of treatment. Processing includes an option to send formalin-fixed paraffin embedded slides [FFPE] slides if a tumor block is not available.
4.Advanced, unresectable (local, regionally, recurrent not amenable to curative therapy) or metastatic disease that has no standard therapeutic option with a proven clinical benefit, are intolerant to or have refused all standard of care options with demonstrated clinical benefit.
5.Expansion Phase only: patient has measurable disease per RECIST v 1.1 criteria.
6.ECOG performance status of 0 or 1.
7.Baseline QTC interval of ≤ 480 msec using Frederica's formula.
8.Acceptable liver function:
-Bilirubin ≤ 1.5 times upper limit of normal
-AST (SGOT) and ALT (SGPT) ≤ 3 times upper limit of normal. If liver metastases are present, then ≤ 5 x ULN is allowed, and
-Serum albumin ≥ 2.5 g/dL.
9.Acceptable renal function, defined as calculated creatinine clearance > 30 mL/min per institution laboratory values.
10.Acceptable hematologic status:
-Hemoglobin ≥ 8 g/dL (no packed red blood cell [PRBC] transfusions allowed within 2 weeks)
-Absolute neutrophil count (ANC) ≥ 1500 cells/mm^3 or ≥ 1.5 x 10^9/L
-Platelet count ≥ 100,000 platelets/mm^3 or ≥ 100 x 10^9/L, and
-Absolute reticulocyte count (x10^9/L) < ULN.
11.Serum haptoglobin (mg/dL) > LLN.
12.Acceptable coagulation status with fibrinogen, above LLN; PT/INR and PTT ≤ 1.5 times upper limit of normal (may be on a stable dose of coumadin with stable INR in the therapeutic range).
13.Life expectancy of at least 3 months.
14.Signed IRB-approved informed consent.
15.Able and willing to comply with the protocol for the duration of the study, including undergoing treatment and scheduled visits and examinations.
16.A negative serum pregnancy test, if female of child-bearing potential.
17.For men and women of child-bearing potential, agreement to the use of at least 1 highly effective contraceptive method(s) during the study and in the 3 months following the last dose of GNX102.
Exclusion Criteria
1.Has any other malignancy not listed in Inclusion Criteria # 2.
2.Has a positive PCR test for active COVID-19 infection or has signs or symptoms consistent with COVID-19 in the absence of a negative PCR test.
3.Has New York Heart Association Class III or IV heart disease.
4.History of myocardial infarction, unstable angina, coronary/peripheral artery bypass graft, within the past 6 months.
5.History of cerebral vascular accident or transient ischemic attack within the past 6 months.
6.History of primary CNS tumor.
7.History of CNS metastases, unless previously treated and stable for at least 4 weeks in the absence of steroids. Patients with meningeal carcinomatosis are excluded regardless of treatment.
8.Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy within 72 hours of start of therapy.
9.Active, nonmalignant GI disease requiring treatment (such as inflammatory bowel disease, Crohn's disease, colitis) that would impart, in the judgment of the investigator and/or sponsor, excess risk associated with study participation or study drug administration, which would make the patient inappropriate for entry into this study.
10.Clinical symptoms of pancreatitis within the past 28 days.
11.Known active infection with HIV, hepatitis B (HBV), or hepatitis C (HCV).
- Patients with a history of HBV or HCV are allowed if HBV DNA or HCV RNA are undetectable. Patients with hepatocellular cancer on anti-viral therapy must have DNA levels ≤ 500 IU/ml.
- Patients with a history of HBV or HCV will be monitored for reactivation while on study.
12.Pregnant or nursing women.
13.Treatment with radiation therapy within 14 days prior to dosing with GNX102.
14.Major surgery within 14 days prior to dosing with GNX102.
15.History of autoimmune hemolytic anemia or autoimmune thrombocytopenia.
16.No second malignancy which is considered active or requires concurrent treatment.
17.For patients with hepatocellular carcinoma
- Ascites requiring more than 1 paracentesis per month
- History of hepatic encephalopathy within 12 months of study entry.
18.History of bleeding esophageal or gastric varices within 6 months of study entry.
19.Prior or ongoing cancer treatment, including investigational treatment within 5 half-lives or 21 days whichever is less, prior to dosing with GNX102 and 6 weeks for nitrosoureas or mitomycin C.
20.Allergies to any excipients in GNX102 (i.e., L-histidine, sucrose, Polysorbate 80).
21.Severe acute or chronic medical or psychiatric conditions or other laboratory abnormalities that would impart, in the judgment of the investigator and/or sponsor, excess risk associated with study participation or study drug administration, which would make the patient inappropriate for entry into this study.
2.Has a positive PCR test for active COVID-19 infection or has signs or symptoms consistent with COVID-19 in the absence of a negative PCR test.
3.Has New York Heart Association Class III or IV heart disease.
4.History of myocardial infarction, unstable angina, coronary/peripheral artery bypass graft, within the past 6 months.
5.History of cerebral vascular accident or transient ischemic attack within the past 6 months.
6.History of primary CNS tumor.
7.History of CNS metastases, unless previously treated and stable for at least 4 weeks in the absence of steroids. Patients with meningeal carcinomatosis are excluded regardless of treatment.
8.Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy within 72 hours of start of therapy.
9.Active, nonmalignant GI disease requiring treatment (such as inflammatory bowel disease, Crohn's disease, colitis) that would impart, in the judgment of the investigator and/or sponsor, excess risk associated with study participation or study drug administration, which would make the patient inappropriate for entry into this study.
10.Clinical symptoms of pancreatitis within the past 28 days.
11.Known active infection with HIV, hepatitis B (HBV), or hepatitis C (HCV).
- Patients with a history of HBV or HCV are allowed if HBV DNA or HCV RNA are undetectable. Patients with hepatocellular cancer on anti-viral therapy must have DNA levels ≤ 500 IU/ml.
- Patients with a history of HBV or HCV will be monitored for reactivation while on study.
12.Pregnant or nursing women.
13.Treatment with radiation therapy within 14 days prior to dosing with GNX102.
14.Major surgery within 14 days prior to dosing with GNX102.
15.History of autoimmune hemolytic anemia or autoimmune thrombocytopenia.
16.No second malignancy which is considered active or requires concurrent treatment.
17.For patients with hepatocellular carcinoma
- Ascites requiring more than 1 paracentesis per month
- History of hepatic encephalopathy within 12 months of study entry.
18.History of bleeding esophageal or gastric varices within 6 months of study entry.
19.Prior or ongoing cancer treatment, including investigational treatment within 5 half-lives or 21 days whichever is less, prior to dosing with GNX102 and 6 weeks for nitrosoureas or mitomycin C.
20.Allergies to any excipients in GNX102 (i.e., L-histidine, sucrose, Polysorbate 80).
21.Severe acute or chronic medical or psychiatric conditions or other laboratory abnormalities that would impart, in the judgment of the investigator and/or sponsor, excess risk associated with study participation or study drug administration, which would make the patient inappropriate for entry into this study.
The Estimated Number of Participants
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Taiwan
15 participants
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Global
60 participants
