A Study of AbGn-107 in Patients With Gastric, Colorectal, Pancreatic or Biliary Cancer (NCT02908451) | Clinical Trial Compass
TerminatedPhase 1
A Study of AbGn-107 in Patients With Gastric, Colorectal, Pancreatic or Biliary Cancer
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.
United States39 participantsStarted 2017-04-24
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
ā. Age ā„18 years. A patient may be of either sex and of any race/ethnicity.
ā. 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).
ā. Patient must not have curative options available (e.g. a single metastatic focus in the liver in a patient with MCRC eligible for metastasectomy).
ā. Chemo-refractory is defined as:
ā. 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) ā„8, via slides from original diagnostic biopsy material or biopsy of recurrent/metastatic disease, prior to enrollment.
ā. Measurable disease by RECIST 1.1 criteria
ā. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1.
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What they're measuring
1
Adverse events (AEs) graded according to CTCAE v4.03.
. Adequate organ function within 3 weeks prior to first study drug administration as evidenced by:
Exclusion criteria
ā. Any persistent, unresolved Common Terminology Criteria for Adverse Events (CTCAE) Grade ā„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 ā„2 due to previous treatment requires discussion with the sponsor.
ā. Radiation therapy within 2 weeks prior to first study drug administration.
ā. Major surgery within 3 weeks prior to first study drug administration.
ā. Any chemotherapy within 30 days of enrollment.
ā. 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).
ā. 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.
ā. 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.
ā. Known active hepatitis B or C. HBV and HCV tests are required prior to Day 1.