NCT01946789

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

A Phase 1 Study of the Clinical and Immunologic Effects of ALT-803, a Novel Recombinant IL-15 Complex in Patients With Advanced Solid Tumors: Melanoma, Renal Cell, Non-Small Cell Lung and Squamous Cell Head and Neck Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Altor BioScience · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The proposed clinical trial is a phase I, open-label, multi-center, dose-escalation study of ALT-803 in patients with surgically incurable advanced solid tumors: melanoma, renal cell, non-small cell lung and squamous cell head and neck cancer

Detailed description

This trial will investigate the safety and immunogenicity, immunomodulatory properties, and clinical benefits of treatment with weekly doses of ALT-803 in patients with advanced solid tumors.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-05-01
• Primary completion: 2017-08-01
• Completion: 2017-12-01
• First posted: 2013-09-20
• Last updated: 2025-01-22
• Results posted: 2025-01-22

Locations

5 sites across 1 country: United States