A Phase 1 Study of the Clinical and Immunologic Effects of ALT-803 in Patients With Advanced Solid Tumors

PHASE1CompletedINTERVENTIONAL
Enrollment

26

Participants

Timeline

Start Date

May 31, 2014

Primary Completion Date

August 31, 2017

Study Completion Date

December 31, 2017

Conditions
Advanced Solid Tumors
Interventions
BIOLOGICAL

ALT-803

N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.

Trial Locations (5)

44195

Cleveland Clinic Foundation, Cleveland

55455

University of Minnesota, Minneapolis

98109

University of Washington, Seattle Cancer Care Alliance, Seattle

03756

Dartmouth Hitchcock Medical Center, Lebanon

08901

Rutgers Cancer Institute of New Jersey, New Brunswick

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Altor BioScience

INDUSTRY

NCT01946789 - A Phase 1 Study of the Clinical and Immunologic Effects of ALT-803 in Patients With Advanced Solid Tumors | Biotech Hunter | Biotech Hunter