An Expanded Access Program for AM0010 (Pegilodecakin)

NCT03554434 — No longer available, Eli Lilly and Company

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An Expanded Access Program for AM0010 (Pegilodecakin) Subcutaneous Injection

RegistryNCT03554434
StatusNo longer available
Study typeExpanded access
SponsorEli Lilly and Company (Industry); collaborators: ARMO BioSciences
ConditionsMelanoma, Prostate Cancer, Ovarian Cancer, Renal Cell Carcinoma, Colorectal Carcinoma, Pancreatic Carcinoma, Non-small Cell Lung Carcinoma, Solid Tumors, Breast Cancer
InterventionsAM0010 (Biological)
Datesfirst posted 2018-06-13, last updated 2020-03-02

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-Summary

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.

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+Arms and interventions

  • AM0010 (Biological), also known as LY3500518, Pegilodecakin: AM0010

+Eligibility

Sex: All, ages: 18 Years to any

* 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

+Investigators

  • Contact Lilly at 1-800-LillyRx (1-800-545-5979), Study director, Eli Lilly and Company