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

Phase 1

Completed

• Conditions: Advanced Solid Tumors
• Interventions: Biological: ALT-803

• Registration Number: NCT01946789
• Lead Sponsor: Altor BioScience

Brief 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.

Study Timeline

• Study First Submitted: 2013-09-11
• Study First Submitted QC: 2013-09-17
• Study First Posted: 2013-09-20
• Study Start: 2014-05
• Primary Completion: 2017-08
• Study Completion: 2017-12
• Results First Submitted: 2024-07-16
• Status Verified: 2025-01
• Results First Submitted QC: 2025-01-20
• Last Update Submitted: 2025-01-20
• Results First Posted: 2025-01-22
• Last Update Posted: 2025-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
N-803 IV 1.0 ug/kg	ALT-803	-
ALT-803	ALT-803	-
N-803 Subcutaneous 6.0 ug/kg	ALT-803	-
N-803 Subcutaneous 10.0 ug/kg	ALT-803	-
N-803 Subcutaneous 20.0 ug/kg	ALT-803	-
N-803 Intratumoral 10.0 ug/kg followed by N-803 15.0 ug/kg subcutaneous	ALT-803	-
N-803 Subcutaneous 15.0 ug/kg	ALT-803	-
N-803 IV 0.3/0.5 ug/kg	ALT-803	-
N-803 IV 3.0 ug/kg	ALT-803	-
N-803 IV 6.0 ug/kg	ALT-803	-

Primary Outcome Measures

Name	Time	Method
Dose Limiting Toxicity	9 months	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Developed Anti-drug Antibodies to ALT-803	14 days post final dose, up to 135 days	Immunogenicity of ALT-803 assessed by ELISA
To Evaluate the Effect of Escalating Doses of ALT-803: Pharmacokinetics (Half Life and Tmax)	24 hours post dose	Pharmacokinetics of ALT-803 assessed by ELISA
To Evaluate the Effect of Escalating Doses of ALT-803: Pharmacokinetics (Cmax)	24 hours after first dose	Pharmacokinetics of ALT-803 assessed by ELISA
To Evaluate the Effect of Escalating Doses of ALT-803: Pharmacokinetics (AUC 0-t, AUC0-24, AUC0-infinity)	24 hours after first dose	Pharmacokinetics of ALT-803 assessed by ELISA
To Evaluate the Effect of Escalating Doses of ALT-803: Interferon Gamma (IFN-γ)	Cycle 1 Week 1, pre-dose; Cycle 1 Week 1, 30 minutes post dose; Cycle 1 Week 1, 2 hours post dose; Cycle 1 Week 1, 4 hours post dose; Cycle 1 Week 1, 8 hours post dose; Cycle 1 Week 1, 24 hours post dose	The level of immune response to autochthonous viral and tumor antigens by interferon gamma (IFN-γ) ELISPOT
Objective Response Rate	Up to 6 months	Number of patients with CR, PR, SD, and PD

Trial Locations

Locations (5)

Dartmouth Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States

Rutgers Cancer Institute of New Jersey; 🇺🇸 New Brunswick, New Jersey, United States

University of Washington, Seattle Cancer Care Alliance; 🇺🇸 Seattle, Washington, United States

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States