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

NCT01466569 | Completed Phase 1

• 1 other identifier: AbGenomics-2010.007.01
• Study Type: interventional
• Target: 13
• Locations: 2 countries
• Sites: 4

Brief Summary

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.

Conditions

Gastric Cancer; Solid Tumor of Epithelial Origin

Keywords

Advanced Solid Tumor; Gastric Cancer; Oncology; monoclonal Antibody

Outcome Measures

Primary Outcomes (1)

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

  10 Weeks

Secondary Outcomes (3)

• Pharmacokinetics will be assessed at 3 different dose levels in phase 1a and at 2 dose levels in phase 1b

  12 Weeks

• Serum anti-drug antibodies will be assessed at 3 different dose levels in phase 1a and at 2 dose levels in phase 1b

  12 weeks

• Tumor response rate by Response Evaluation Criteria in Solid Tumors (RECIST)

  10 weeks

Study Arms (5)

AbGn-7 phase 1a cohort 1

EXPERIMENTAL

Drug: AbGn-7

AbGn-7 phase 1a cohort 2

EXPERIMENTAL

Drug: AbGn-7

AbGn-7 phase 1a cohort 3

EXPERIMENTAL

Drug: AbGn-7

AbGn-7 phase 1b cohort 1

EXPERIMENTAL

Drug: AbGn-7

AbGn-7 phase 1b cohort 2

EXPERIMENTAL

Drug: AbGn-7

Interventions

AbGn-7 DRUG

Phase 1a: dose escalation; Drug: AbGn-7 weekly iv infusion Duration: 6 weeks

AbGn-7 phase 1a cohort 1; AbGn-7 phase 1a cohort 2; AbGn-7 phase 1a cohort 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• AbGenomics B.V Taiwan Branch: lead

Study Sites (4)

Fox Chase Cancer Center

Rockledge, Pennsylvania, 19046, United States

Location

The University of Texas Health Science Center-CTRC

San Antonio, Texas, 78229, United States

Location

MacKay Memorial Hospital

Taipei, 104, Taiwan

Location

National Taiwan University Hospital

Taipei, 104, Taiwan

Location

MeSH Terms

Conditions

Stomach Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Shih-Yao Lin, MD, PhD

  AbGenomics B.V Taiwan Branch

  STUDY DIRECTOR

• Devalingham Mahalingam, MD

  The University of Texas Health Science Center-CTRC

  PRINCIPAL INVESTIGATOR

• Anthony Olaszanski, MD, RPh

  Fox Chase Cancer Center

  PRINCIPAL INVESTIGATOR

• Kuen-Hui Yeh, MD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

• Ruey-Kuen Hsieh, MD

  Mackay Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2011
• First Posted: November 8, 2011
• Study Start: November 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: June 23, 2015

Record last verified: 2015-06

Locations

TW (2); US (2)