Phase I Study of Soluble LAG-3 (IMP321) and Gemcitabine in Patients With Advanced Pancreas Cancer
This is a phase I, single center, open label, non-randomized, dose-escalation phase I study
performed in the ambulatory setting in patients receiving first line chemotherapy for
unresectable pancreas cancer with gemcitabine weekly and the investigational agent IMP321.
IMP321 will be given at D2 and D16 of a 4-week cycle, for a period of 6 months. The
hypothesis of this study is that IMP321 is safe for human administration. Additionally we
hypothesize that IMP321 elicits an immunomodulatory effect that is therapeutic in the
treatment of pancreas cancer.
- To evaluate the safety and tolerability of repeated IMP321 subcutaneous injections in
patients being treated with gemcitabine for advanced pancreas cancer.
- To determine any dose limiting toxicities of IMP321 in patients being treated with
gemcitabine for advanced pancreas cancer.
- To describe the pharmacokinetics of the last IMP321 subcutaneous injection compared to
the first one, in a limited number of patients.
- To determine the pharmacodynamics of IMP321 therapy by:
- Quantify peripheral blood Treg (CD4+CD25+FoxP3+ T cells) in pancreatic cancer patients
before and during treatment with IMP321 by flow cytometry.
- Evaluate the B- and T-cell responses to the pancreatic cancer-expressed antigen,
mesothelin, by testing for antibodies and T-cell response by ELISpot.
- To evaluate the clinical response and time to disease progression with computed
tomography examinations at two month intervals (current standard of care in
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate the safety and tolerability of repeated IMP321 subcutaneous injections in patients being treated with gemcitabine for advanced pancreas cancer.
William G. Hawkins, M.D.
United States: Food and Drug Administration
|Washington University||St. Louis, Missouri 63110|