An Expanded Access Program for AM0010 (Pegilodecakin)

Lilly

Status

Conditions: Colorectal Carcinoma; Breast Cancer; Melanoma; Solid Tumors; Renal Cell Carcinoma; Ovarian Cancer; Non-small Cell Lung Carcinoma; Prostate Cancer; Pancreatic Carcinoma

Treatments: Biological: AM0010

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT03554434

AM0010-99

Details and patient eligibility

About

This is an Expanded Access Program (EAP) available to patients who have advanced cancers, who have failed or progressed on standard of care systemic therapy and do not qualify for ongoing clinical trials.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• Patient is NOT eligible for other AM0010 clinical trials currently open in the region
• Patient is in urgent need of therapy who fail to meet eligibility criteria for other clinical trials related to AM0010 (PEG-IL-10) can be considered for enrollment into this Expanded Access Program.
• Patient has advanced cancer in indications where preliminary anti-tumor efficacy of AM0010 has been demonstrated or where AM0010 mediated immune activation is likely to benefit the patient.
• Patient has failed or progressed on standard of care (SOC) systemic therapy
• Patient is refusing SOC therapy