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A Study of AbGn-107 in Patients With Gastric, Colorectal, Pancreatic or Biliary Cancer

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ClinicalTrials.gov Identifier: NCT02908451
Recruitment Status : Recruiting
First Posted : September 21, 2016
Last Update Posted : August 26, 2019
Sponsor:
Information provided by (Responsible Party):
AbGenomics B.V Taiwan Branch

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Colorectal Cancer Pancreatic Cancer Biliary Cancer Biological: AbGn-107 Phase 1

Detailed Description:
AbGn-107 is an antibody drug conjugate (ADC) which targets an antigen (AG7 antigen) present in gastric, colorectal, pancreatic cancer or biliary cancer. This study is a standard 3 + 3 dose escalation design with cohort expansion. AbGn-107 will be administered every 14 days (Q2W regimen) or 28 days (Q4W regimen) in patients with chemo-refractory locally advanced, recurrent or metastatic gastric, colorectal, pancreatic adenocarcinoma or biliary cancer. The primary objectives of this study are to define the safety profile and to determine the maximum tolerated dose regimen of AbGn-107, and the secondary objectives are to evaluate the pharmacokinetic (PK) parameters, the immunogenicity, and preliminary efficacy of AbGn-107.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 136 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 24, 2017
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : December 2020


Arm Intervention/treatment
Experimental: AbGn-107
AbGn-107 will be administered every 14-days or 28-days via intravenous infusion. Patients with a complete response (CR), partial response (PR), or stable disease (SD), or with evidence of clinical benefit may be treated every continuously every 14-days or 28-days..
Biological: AbGn-107
Antibody Drug Conjugate
Other Name: Ab1-18Hr1




Primary Outcome Measures :
  1. Adverse events (AEs) graded according to CTCAE v4.03. [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: 70 days after treatment ]
  2. Tmax (time from dosing to maximum measured concentration) [ Time Frame: 70 days after treatment ]
  3. T1/2 (half-life of the analyte) [ Time Frame: 70 days after treatment ]
  4. Immunogenicity evaluation based on anti-drug antibodies titer [ Time Frame: 70 days after treatment ]
  5. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

    1. Patient must not have curative options available (e.g. a single metastatic focus in the liver in a patient with MCRC eligible for metastasectomy).
    2. 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 or pancreatic or biliary cancers.
      • 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 to confirmed high expression of AG7 antigen during the Pre-Screening period, defined as immune reactive score (IRS) ≥8, via slides from original diagnostic biopsy material or biopsy of recurrent/metastatic disease, prior to enrollment.
  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:

    1. Absolute neutrophil count ≥1.5 x 10^9/L,
    2. Hemoglobin ≥9 g/dL,
    3. Platelet count ≥100 x 10^9/L,
    4. Serum creatinine ≤1.5 x upper limit of normal (ULN) or a calculated creatinine clearance >60 mL/min,
    5. Total bilirubin <1.5 x ULN, except for patients with Gilbert's disease who are eligible if total bilirubin ≤ 3 mg/dL.
    6. 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. Known active hepatitis B or C. HBV and HCV tests are required 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 evaluations or optimal participation in the study.
  10. Pregnancy or breastfeeding.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02908451


Contacts
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Contact: Hazel Cheng, PhD 9497860390 hazel.cheng@abgenomics.com
Contact: Irene Cheng, PhD +886 2 2627 2707 ext 406 irene.cheng@abgenomics.com

Locations
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United States, Arizona
Mayo Clinic Recruiting
Phoenix, Arizona, United States, 85054
Contact: Justin Weber    480-342-6029    Weber.Justin@mayo.edu   
Principal Investigator: Tanios S Bekaii-Saab, MD         
United States, California
University of California Recruiting
San Francisco, California, United States, 94143
Contact: Pranay Chaurasia    415-353-8449    Pranay.Chaurasia@ucsf.edu   
Principal Investigator: Andrew Ko, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Amy Gisondi       AGISONDI@mgh.harvard.edu   
Principal Investigator: Jeffrey Clark, MD         
Beth-Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Justin Sun    617-975-7463    jsun7@bidmc.harvard.edu   
Principal Investigator: Benjamin Schlechter, MD         
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Alexandra Bird    617-632-5575    Alexandra_Bird@DFCI.HARVARD.EDU   
Principal Investigator: Brian M Wolpin, MD         
United States, Washington
University of Washington, Seattle Cancer Care Alliance Recruiting
Seattle, Washington, United States, 98109
Contact: Camille Biggins    206-606-1646    cbiggins@seattlecca.org   
Principal Investigator: Andrew Coveler, MD         
Taiwan
China Medical University Hospital Not yet recruiting
Taichung, Taiwan, 404
Contact: Yu-Ting Ho    04-22052121 ext 5057    blessyou1982@gmail.com   
Principal Investigator: Li-Yuan Bai         
National Cheng Kung University Hospital Not yet recruiting
Tainan, Taiwan, 48
Contact: Ray-Fan Su    0910-876172    srf106@gmail.com   
Principal Investigator: Chia-Jui Yen         
National Taiwan University Hospital Not yet recruiting
Taipei, Taiwan, 100
Principal Investigator: Chia-Chi Lin         
Sponsors and Collaborators
AbGenomics B.V Taiwan Branch
Investigators
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Study Director: Shih-Yao (David) Lin, MD, PhD AbGenomics B.V.
Principal Investigator: Andrew Ko, MD University of California, San Francisco

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Responsible Party: AbGenomics B.V Taiwan Branch
ClinicalTrials.gov Identifier: NCT02908451     History of Changes
Other Study ID Numbers: 2016.006.01
First Posted: September 21, 2016    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AbGenomics B.V Taiwan Branch:
Cancer
Antibody Drug Conjugate
AbGn-107
Adenocarcinoma
Gastric
Colorectal
Pancreatic
biliary
cholangiocarcinoma
gallbladder
ampullary carcinomas
Additional relevant MeSH terms:
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Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Biliary Tract Diseases
Immunoconjugates
Immunologic Factors
Physiological Effects of Drugs