An A/B Dose Escalation Study of AbGn-7 Alone and With FOLFOX7 Treatment in Patients With Advanced Solid Tumors

Completed · Phase 1

Conditions studied: Solid Tumor of Epithelial Origin, Gastric Cancer

In brief

The purpose of this study is to determine the safety and tolerability profile including the dose limiting toxicity of AbGn-7 in patients with chemo-refractory advanced solid tumor of epithelial origin, and of AbGn-7 in combination with FOLFOX7 in patients with chemo-naive/chemo-refractory recurrent, locally advanced or metastatic gastric cancer.

Key facts

Study ID

NCT01466569

Run by

AbGenomics B.V Taiwan Branch

People needed

13

Starts

2011-11-01

Expected to finish

2013-01-01

Last updated by the study team

2015-06-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• must provide written informed consent.
• must be ≥18 years of age, either sex and of any race/ethnicity.
• Phase 1a: must have a histologically or cytologically confirmed advanced malignant solid tumor of epithelial origin and must have failed on previous chemotherapy. Phase 1b: must have a histologically or cytologically confirmed, recurrent, locally advanced or metastatic gastric cancer with measurable disease; must be chemo-naïve or must have failed on previous chemotherapy; must not have received an oxaliplatin-based chemotherapeutic regimen or monoclonal antibody therapy.
• must have an Eastern Cooperative Oncology Group Performance Status of ≤2.
• must have adequate hematological, renal and liver functions within 3 weeks prior to first study drug administration as evidenced by: a) Absolute neutrophil count ≥1.5 x 109/L, b) Hemoglobin ≥90 g/L (≥80 g/L for patients with documented renal cell carcinoma), 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/minute, e) Total bilirubin <1.5 x ULN, except for patients with documented Gilbert's disease, f) AST/SGOT and ALT/SGPT < 2.5 x ULN, or, in the presence of documented liver metastases, ≤5 x ULN.
• must be able to adhere to dose and visit schedules.
• Each female patient of childbearing potential must agree to use a medically accepted method of contraception or to abstain from sexual intercourse and each male patient must agree to use a medically accepted method of contraception or to abstain from sexual intercourse during the study and for 60 days after stopping the study drug.
• A life expectancy of at least 3 months.
• Available tumor tissue in the form of unstained slides for determination of AbGn-7 epitope expression (optional for Phase 1a, obligatory for Phase 1b). Patients without archival/banked tumor tissue obtained at the time of initial diagnosis must have a biopsy performed according to institutional guidelines prior to the initiation of treatment.

You may not qualify if…

• No current treated or untreated leptomeningeal metastasis or a metastatic CNS lesion.
• For Phase 1a, patients should not have received chemotherapy within 30 days prior to initiation of AbGn-7 therapy. For Phase 1b, patients should not have received oxaliplatin-based chemotherapy or monoclonal antibody therapy for their gastric cancer prior to enrollment.
• Have note received radiation therapy within 3 weeks prior to first study drug administration and must have adequately recovered from any associated toxicity and/or complications of this intervention.
• Have not undergone major surgery within 3 weeks prior to the first study drug administration and must have adequately recovered from the toxicity and/or complications of these interventions.
• No current human immunodeficiency virus (HIV) infection or a current HIV-related malignancy.
• No current active hepatitis B or C.
• No any serious or uncontrolled infection.
• No uncontrolled diabetes mellitus, defined as a HbA1c of ≥7.5% in a patient with documented diabetes mellitus.
• No any of the following within 6 months prior to first study drug administration: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, clinically significant cardiac dysrhythmia or clinically significant ECG abnormality, cerebrovascular accident or transient ischemic attack, or seizure disorder.
• No persistent, unresolved NCI CTCAE Grade ≥2 drug-related toxicity associated with previous chemotherapy.
• Not participating in any other clinical study with a potentially therapeutic agent, or have not received another investigational product within 21 days.
• No any clinically significant condition or situation which would interfere with the study evaluations or optimal participation in the study.

Where it is running

• Fox Chase Cancer Center — Rockledge, Pennsylvania, United States
• The University of Texas Health Science Center-CTRC — San Antonio, Texas, United States
• MacKay Memorial Hospital — Taipei, Taiwan
• National Taiwan University Hospital — Taipei, Taiwan

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.