Clinical Trials List
Protocol Number2016.006.01
NCT Number(ClinicalTrials.gov Identfier)NCT02908451
2019-03-01 - 2021-12-31
Phase I
Terminated3
ICD-9199.0
Disseminated malignant neoplasm
A Phase I Dose Escalation Study, With Cohort Expansion, to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of AbGn-107 Therapy in Patients With Chemo-refractory Locally Advanced, Recurrent, or Metastatic Gastric, Colorectal, Pancreatic or Biliary Cancer
-
Trial Applicant
Clinipace Taiwan Co., Ltd
-
Sponsor
AbGenomics BV, Taiwan Branch
-
Trial scale
Multi-Regional Multi-Center
-
Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Ming-Hung Tsai Division of Hematology & Oncology
- Che-Hung Lin Division of Hematology & Oncology
- Chi-Ching Chen Division of Hematology & Oncology
- Chang-Fang Chiu Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Yan-Shen Shan Division of General Surgery
- Shang-Yin Wu Division of General Internal Medicine
- 趙盈瑞 Division of General Surgery
- Yu-Min Yeh Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Kun-Huei Yeh Division of Hematology & Oncology
- 梁逸歆 Division of Hematology & Oncology
- SHIH-HUNG YANG 未分科
- Chih-Hung Hsu Division of Hematology & Oncology
- 陳國興 Division of Hematology & Oncology
- Chiun Hsu Division of Hematology & Oncology
- SHIH-HUNG YANG Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Condition/Disease
Gastric, Colorectal, Pancreatic or Biliary Cancer
Objectives
This study is to define the safety profile and to determine the Maximal tolerated dose regimen and preliminary efficacy of AbGn-107 administered every 14 days (Q2W regimen) or 28 days (Q4W regimen) in patients with chemo-refractory locally advanced, recurrent or metastatic gastric, colorectal, pancreatic or biliary cancer.
Test Drug
AbGn-107
Active Ingredient
AbGn-107
Dosage Form
injection
Dosage
10 mg/mL
Endpoints
Primary Outcome Measures :
Adverse events (AEs) graded according to CTCAE v4.03. [ Time Frame: 28 days ]
Secondary Outcome Measures :
Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: 70 days after treatment ]
Tmax (time from dosing to maximum measured concentration) [ Time Frame: 70 days after treatment ]
T1/2 (half-life of the analyte) [ Time Frame: 70 days after treatment ]
Immunogenicity evaluation based on anti-drug antibodies titer [ Time Frame: 70 days after treatment ]
Overall Response Rate Evaluated by Response Evaluation Criteria in Solid Tumor (RECIST) [ Time Frame: Every 2 treatment cycles for Q4W regimen or every 4 treatment cycles for Q2W regimen, up to 2 years from the first patient enrolled ]
Adverse events (AEs) graded according to CTCAE v4.03. [ Time Frame: 28 days ]
Secondary Outcome Measures :
Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: 70 days after treatment ]
Tmax (time from dosing to maximum measured concentration) [ Time Frame: 70 days after treatment ]
T1/2 (half-life of the analyte) [ Time Frame: 70 days after treatment ]
Immunogenicity evaluation based on anti-drug antibodies titer [ Time Frame: 70 days after treatment ]
Overall Response Rate Evaluated by Response Evaluation Criteria in Solid Tumor (RECIST) [ Time Frame: Every 2 treatment cycles for Q4W regimen or every 4 treatment cycles for Q2W regimen, up to 2 years from the first patient enrolled ]
Inclution Criteria
Inclusion criteria
1. Age ≥18 years. A patient may be of either sex and of any race/ethnicity.
2. Histologically confirmed, chemo-refractory, locally advanced, recurrent or metastatic
gastric (including GE junction), colorectal, or pancreatic adenocarcinoma or biliary
cancer (including cholangiocarcinoma, gallbladder and ampullary carcinomas).
a. Patient must not have curative options available (e.g. a single metastatic focus in the
liver in a patient with MCRC eligible for metastasectomy).
b. Chemo-refractory is defined as:
- Progression on or following, or intolerant of, at least one prior line of standard
systemic therapy for advanced or metastatic gastric pancreatic or biliary cancer.
- Progression on or following, or intolerant of, at least two prior lines of standard
systemic therapy for advanced or metastatic colorectal cancers.
- Patients who have progressed/recurred following neoadjuvant/adjuvant
chemotherapy for earlier stage disease, if completed within the previous 6 months,
are eligible.
3. Archived tissue must be available for all patients (both dose escalation and expansion
cohorts). Dose Escalation Only-If tissue is not available, patients may still be considered
eligible for enrollment, if all other eligibility criteria are confirmed and after discussion
with and approval by the sponsor medical monitor. Cohort Expansion Only-Tissue must
be confirmed positive for expression of AG7 antigen during the Pre-Screening period,
defined as proportional score ≥2, via slides or tumor block from original diagnostic
biopsy material or biopsy of relapsed disease, prior to enrollment (Refer to Section 5.6).
4. Measurable disease by RECIST 1.1 criteria.
5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1.
6. Adequate organ function within 3 weeks prior to first study drug administration as
evidenced by:
a) Absolute neutrophil count ≥1.5 x 109
/L,
b) Hemoglobin ≥9 g/dL,
c) Platelet count ≥100 x 109
/L,
d) Serum creatinine ≤1.5 x upper limit of normal (ULN) or a calculated creatinine
clearance >60 mL/min,
e) Total bilirubin <1.5 x ULN, except for patients with Gilbert’s disease who are eligible
if total bilirubin ≤ 3mg/dL.
f) Aspartate aminotransferase (AST)/serum glutamic-oxalacetic transaminase (SGOT)
and alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT) <2.5 x
ULN, or, in the presence of documented liver metastases, ≤5 x ULN.
7. Ability to adhere to dose and visit schedules.
8. Women of childbearing potential (WOCP) must have a negative pregnancy test result
prior to enrollment. WOCP and men whose partners are WOCP must agree to use a highly
effective method of birth control during the study and for 6 months following the last
dose of study drug. A highly effective method of birth control is defined as one which
results in a low failure rate (less than 1% per year).
9. Ability to provide written informed consent.
10. Life expectancy of at least 3 months
1. Age ≥18 years. A patient may be of either sex and of any race/ethnicity.
2. Histologically confirmed, chemo-refractory, locally advanced, recurrent or metastatic
gastric (including GE junction), colorectal, or pancreatic adenocarcinoma or biliary
cancer (including cholangiocarcinoma, gallbladder and ampullary carcinomas).
a. Patient must not have curative options available (e.g. a single metastatic focus in the
liver in a patient with MCRC eligible for metastasectomy).
b. Chemo-refractory is defined as:
- Progression on or following, or intolerant of, at least one prior line of standard
systemic therapy for advanced or metastatic gastric pancreatic or biliary cancer.
- Progression on or following, or intolerant of, at least two prior lines of standard
systemic therapy for advanced or metastatic colorectal cancers.
- Patients who have progressed/recurred following neoadjuvant/adjuvant
chemotherapy for earlier stage disease, if completed within the previous 6 months,
are eligible.
3. Archived tissue must be available for all patients (both dose escalation and expansion
cohorts). Dose Escalation Only-If tissue is not available, patients may still be considered
eligible for enrollment, if all other eligibility criteria are confirmed and after discussion
with and approval by the sponsor medical monitor. Cohort Expansion Only-Tissue must
be confirmed positive for expression of AG7 antigen during the Pre-Screening period,
defined as proportional score ≥2, via slides or tumor block from original diagnostic
biopsy material or biopsy of relapsed disease, prior to enrollment (Refer to Section 5.6).
4. Measurable disease by RECIST 1.1 criteria.
5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1.
6. Adequate organ function within 3 weeks prior to first study drug administration as
evidenced by:
a) Absolute neutrophil count ≥1.5 x 109
/L,
b) Hemoglobin ≥9 g/dL,
c) Platelet count ≥100 x 109
/L,
d) Serum creatinine ≤1.5 x upper limit of normal (ULN) or a calculated creatinine
clearance >60 mL/min,
e) Total bilirubin <1.5 x ULN, except for patients with Gilbert’s disease who are eligible
if total bilirubin ≤ 3mg/dL.
f) Aspartate aminotransferase (AST)/serum glutamic-oxalacetic transaminase (SGOT)
and alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT) <2.5 x
ULN, or, in the presence of documented liver metastases, ≤5 x ULN.
7. Ability to adhere to dose and visit schedules.
8. Women of childbearing potential (WOCP) must have a negative pregnancy test result
prior to enrollment. WOCP and men whose partners are WOCP must agree to use a highly
effective method of birth control during the study and for 6 months following the last
dose of study drug. A highly effective method of birth control is defined as one which
results in a low failure rate (less than 1% per year).
9. Ability to provide written informed consent.
10. Life expectancy of at least 3 months
Exclusion Criteria
1. Any persistent, unresolved Common Terminology Criteria for Adverse Events (CTCAE)
Grade ≥2 drug-related toxicity (except alopecia, erectile impotence, tinnitus, hot flashes,
and loss of libido) associated with previous treatment. Inclusion of patients with
persistent neuropathy or hearing loss Grade ≥2 due to previous treatment requires
discussion with the sponsor.
2. Radiation therapy within 2 weeks prior to first study drug administration.
3. Major surgery within 3 weeks prior to first study drug administration.
4. Any chemotherapy within 30 days of enrollment.
5. Participation in any other clinical study with a potentially therapeutic agent or receipt of
another investigational product within 21 days or 5 plasma half-lives, whichever is
longer, prior to first day of drug administration (Day 1).
6. Active central nervous system metastases. Patients with a history of brain metastases may
be eligible, provided they have been definitively treated and are clinically stable, after
discussion with sponsor. Treated or untreated leptomeningeal disease is not permitted.
7. Known human immunodeficiency virus (HIV) infection or a known HIV-related
malignancy. Note: HIV testing is not required unless there is any clinical suspicion that
the patient might be HIV positive.
8. Active hepatitis B or C infection. HBV and HCV testing will be performed per protocol
prior to Day 1.
9. Any clinically significant condition or situation, other than the condition being studied
that, in the opinion of the investigator, would impair with their ability to receive or
tolerate the planned treatment, or interfere with the study evaluation or optimal
participation in the study.
Grade ≥2 drug-related toxicity (except alopecia, erectile impotence, tinnitus, hot flashes,
and loss of libido) associated with previous treatment. Inclusion of patients with
persistent neuropathy or hearing loss Grade ≥2 due to previous treatment requires
discussion with the sponsor.
2. Radiation therapy within 2 weeks prior to first study drug administration.
3. Major surgery within 3 weeks prior to first study drug administration.
4. Any chemotherapy within 30 days of enrollment.
5. Participation in any other clinical study with a potentially therapeutic agent or receipt of
another investigational product within 21 days or 5 plasma half-lives, whichever is
longer, prior to first day of drug administration (Day 1).
6. Active central nervous system metastases. Patients with a history of brain metastases may
be eligible, provided they have been definitively treated and are clinically stable, after
discussion with sponsor. Treated or untreated leptomeningeal disease is not permitted.
7. Known human immunodeficiency virus (HIV) infection or a known HIV-related
malignancy. Note: HIV testing is not required unless there is any clinical suspicion that
the patient might be HIV positive.
8. Active hepatitis B or C infection. HBV and HCV testing will be performed per protocol
prior to Day 1.
9. Any clinically significant condition or situation, other than the condition being studied
that, in the opinion of the investigator, would impair with their ability to receive or
tolerate the planned treatment, or interfere with the study evaluation or optimal
participation in the study.
The Estimated Number of Participants
-
Taiwan
36 participants
-
Global
80 participants
