Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Melanoma

Head and Neck Neoplasms

Intravenous infusion for dose level 1-5; subcutaneous injection for dose level 5a-8; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles

ALT-803

Marc Ernstoff, MD

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

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.

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

Safety and effectiveness of ALT-803 on the peripheral blood white blood cell (WBC) and absolute lymphocyte (ALC) counts. Defined by the increase in the total number of peripheral lymphocytes during the first cycle. The safety endpoint is the MTD of ALT-803, defined as the dose level below that at which ≥2 of 6 patients experience a DLT. The efficacy endpoint is the OBD, defined as that which produces an ALC ≥25,000/µL and/or a total WBC ≥35,000/µL among 2/3 of patients. For safety, we have also defined an "exceeding OBD" as the occurrence of ALC ≥35,000/µL and/or WBC ≥50,000/µL.

On the number and phenotype of peripheral blood mononuclear cells (PBMCs)by multiparameter blood flow, the level of immune response to autochthonous viral and tumor antigens by interferon gamma (IFN-γ) ELISPOT, immunogenicity and pharmacokinetics of ALT-803 assessed by ELISA and overall objective response rate (ORR) and response duration assessed by evidence of antitumor activity as defined by objective responses and the pharmacokinetic and pharmacodynamic profiles of ALT-803

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Phase 1 Study of the Clinical and Immunologic Effects of ALT-803 in Patients With Advanced Solid Tumors	NCT01946789	Advanced Solid ...	ALT-803	18 Years -	Altor BioScience
A Phase 1 Study of the Clinical and Immunologic Effects of ALT-803 in Patients With Advanced Solid Tumors	NCT01946789	Advanced Solid ...	ALT-803	18 Years -	Altor BioScience

Spots Global Cancer Trial Database for squamous cell head and neck