Study Stopped
COVID-19 pandemic has caused a huge operational difficulty for this ongoing clinical trial, as many hospitals have set limitations on onsite staff, patient visits, study related procedures and onsite monitoring visits.
A Study of AbGn-107 in Patients With Gastric, Colorectal, Pancreatic or Biliary Cancer
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
1 other identifier
interventional
39
2 countries
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 gastric-cancer
Started Apr 2017
Typical duration for phase_1 gastric-cancer
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 6, 2016
CompletedFirst Posted
Study publicly available on registry
September 21, 2016
CompletedStudy Start
First participant enrolled
April 24, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2021
CompletedJuly 13, 2021
July 1, 2020
3.9 years
September 6, 2016
July 8, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adverse events (AEs) graded according to CTCAE v4.03.
28 days
Secondary Outcomes (5)
Cmax (maximum measured concentration of the analyte in plasma)
70 days after treatment
Tmax (time from dosing to maximum measured concentration)
70 days after treatment
T1/2 (half-life of the analyte)
70 days after treatment
Immunogenicity evaluation based on anti-drug antibodies titer
70 days after treatment
Overall Response Rate Evaluated by Response Evaluation Criteria in Solid Tumor (RECIST)
Every 2 treatment cycles for Q4W regimen or every 4 treatment cycles for Q2W regimen, up to 2 years from the first patient enrolled
Study Arms (1)
AbGn-107
EXPERIMENTALAbGn-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..
Interventions
Eligibility Criteria
You may qualify if:
- Age ≥18 years. A patient may be of either sex and of any race/ethnicity.
- 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).
- Patient must not have curative options available (e.g. a single metastatic focus in the liver in a patient with MCRC eligible for metastasectomy).
- 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.
- 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.
- Measurable disease by RECIST 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1.
- Adequate organ function within 3 weeks prior to first study drug administration as evidenced by:
- Absolute neutrophil count ≥1.5 x 10\^9/L,
- Hemoglobin ≥9 g/dL,
- Platelet count ≥100 x 10\^9/L,
- Serum creatinine ≤1.5 x upper limit of normal (ULN) or a calculated creatinine clearance \>60 mL/min,
- +6 more criteria
You may not qualify if:
- Radiation therapy within 2 weeks prior to first study drug administration.
- Major surgery within 3 weeks prior to first study drug administration.
- Any chemotherapy within 30 days of enrollment.
- 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).
- 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.
- 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.
- Known active hepatitis B or C. HBV and HCV tests are required prior to Day 1.
- 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.
- Pregnancy or breastfeeding.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Mayo Clinic
Phoenix, Arizona, 85054, United States
University of California
San Francisco, California, 94143, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Beth-Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
University of Washington, Seattle Cancer Care Alliance
Seattle, Washington, 98109, United States
China Medical University Hospital
Taichung, 404, Taiwan
National Cheng Kung University Hospital
Tainan, 48, Taiwan
National Taiwan University Hospital
Taipei, 100, Taiwan
Related Publications (1)
Ko AH, Coveler AL, Schlechter BL, Bekaii-Saab T, Wolpin BM, Clark JW, Bockorny B, Bai LY, Lin YC, Chiang E, Langecker P, Lin SY. A multicenter phase Ia study of AbGn-107, a novel antibody-drug conjugate, in patients with advanced gastrointestinal cancer. Invest New Drugs. 2024 Apr;42(2):221-228. doi: 10.1007/s10637-024-01430-6. Epub 2024 Mar 5.
PMID: 38441850DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Shih-Yao (David) Lin, MD, PhD
AbGenomics B.V.
- PRINCIPAL INVESTIGATOR
Andrew Ko, MD
University of California, San Francisco
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 6, 2016
First Posted
September 21, 2016
Study Start
April 24, 2017
Primary Completion
February 28, 2021
Study Completion
February 28, 2021
Last Updated
July 13, 2021
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share