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A Phase 1 A/B Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AbGn-7 Therapy Alone and in Combination With the FOLFOX7 Treatment Regimen in Patients With Advanced Solid Tumors


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Solid Tumor of Epithelial Origin, Gastric Cancer

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Trial Information

A Phase 1 A/B Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AbGn-7 Therapy Alone and in Combination With the FOLFOX7 Treatment Regimen in Patients With Advanced Solid Tumors


Monoclonal antibodies, alone or in combination with chemotherapeutic agents, have been
proven to be effective treatment for many malignant diseases in human. Antibodies can
mediate cytotoxicity through complement dependent cytotoxicty (CDC), antibody dependent cell
mediated cytotoxicity (ADCC) or apoptosis.

AbGn-7 was identified based on its direct killing (apoptosis-inducing) activities towards
cancer cells expressing its epitope. In vitro data also demonstrated its ability to elicit
CDC and ADCC. The in vivo xenograft study of AbGn-7 demonstrated that AbGn-7 alone or in
combination with chemotherapeutic agents successfully suppressed the growth of gastric,
pancreatic, and colorectal tumours. The NHP study proved the safety profile of AbGn-7. The
present Phase 1 clinical study is designed to evaluate the safety and tolerability of AbGn-7
alone in patients with solid tumors of epithelial origin (Phase 1a) and in combination with
a current chemotherapeutic regimen FOLFOX7 in patients with recurrent, locally advanced or
metastatic gastric carcinoma (Phase 1b).


Inclusion Criteria:



1. must provide written informed consent.

2. must be ≥18 years of age, either sex and of any race/ethnicity.

3. 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.

4. must have an Eastern Cooperative Oncology Group Performance Status of ≤2.

5. 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.

6. must be able to adhere to dose and visit schedules.

7. 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.

8. A life expectancy of at least 3 months.

9. 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.

Exclusion Criteria:

1. No current treated or untreated leptomeningeal metastasis or a metastatic CNS lesion.

2. 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.

3. 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.

4. 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.

5. No current human immunodeficiency virus (HIV) infection or a current HIV-related
malignancy.

6. No current active hepatitis B or C.

7. No any serious or uncontrolled infection.

8. No uncontrolled diabetes mellitus, defined as a HbA1c of ≥7.5% in a patient with
documented diabetes mellitus.

9. 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.

10. No persistent, unresolved NCI CTCAE Grade ≥2 drug-related toxicity associated with
previous chemotherapy.

11. Not participating in any other clinical study with a potentially therapeutic agent,
or have not received another investigational product within 21 days.

12. No any clinically significant condition or situation which would interfere with the
study evaluations or optimal participation in the study.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety will be assessed by analysis of adverse event, clinical laboratory tests and physical examination

Outcome Time Frame:

10 Weeks

Safety Issue:

Yes

Principal Investigator

Shih-Yao Lin, MD, PhD

Investigator Role:

Study Director

Investigator Affiliation:

AbGenomics B.V Taiwan Branch

Authority:

United States: Food and Drug Administration

Study ID:

AbGenomics-2010.007.01

NCT ID:

NCT01466569

Start Date:

November 2011

Completion Date:

July 2013

Related Keywords:

  • Solid Tumor of Epithelial Origin
  • Gastric Cancer
  • Advanced Solid Tumor
  • Gastric Cancer
  • Oncology
  • monoclonal Antibody
  • Stomach Neoplasms
  • Neoplasms

Name

Location

Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
The University of Texas Health Science Center-CTRCSan Antonio, Texas  78229