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

NCT01466569 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2015-06-23

No results posted yet for this study

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

Interventions

DRUG

AbGn-7

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

DRUG

AbGn-7

Phase 1b: two doses (one dose below MTD/MAD and MTD/MAD as determined in phase 1a) Drug: AbGn-7 weekly iv infusion combined with FOLFOX7 Duration: 6 weeks

Sponsors & Collaborators

  • AbGenomics B.V Taiwan Branch

    lead INDUSTRY

Principal Investigators

  • Shih-Yao Lin, MD, PhD · AbGenomics B.V Taiwan Branch

  • Devalingham Mahalingam, MD · The University of Texas Health Science Center-CTRC

  • Anthony Olaszanski, MD, RPh · Fox Chase Cancer Center

  • Kuen-Hui Yeh, MD · National Taiwan University Hospital

  • Ruey-Kuen Hsieh, MD · Mackay Memorial Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2013-01-31
Completion
2013-01-31

Countries

  • United States
  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01466569 on ClinicalTrials.gov