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NCT03554434 Clinical Trial

An Expanded Access Program for AM0010 (Pegilodecakin)

Breast Cancer Clinical Trial

Official title:
An Expanded Access Program for AM0010 (Pegilodecakin) Subcutaneous Injection

Clinical Trial Details — Status: No longer available

Administrative data
NCT number NCT03554434
Other study ID # AM0010-99
Secondary ID
Status No longer available
Phase
First received
Last updated

Study information
Verified date February 2020
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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.

Recruitment information / eligibility
Status No longer available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility - 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

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• AM0010
AM0010

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Eli Lilly and Company ARMO BioSciences
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