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Lab-Made immune protein takes on advanced cancers in first human test

NCT ID NCT02009449

Disease control Sponsor: Eli Lilly and Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 09, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This study tests a new drug called pegilodecakin, a lab-made version of a natural immune protein (interleukin-10), in people with advanced solid tumors such as melanoma, lung, breast, prostate, ovarian, kidney, colorectal, and pancreatic cancers. The drug is given as a daily shot under the skin, either alone or together with standard chemotherapy. The main goals are to check the drug's safety, find the best dose, and see if it helps control tumor growth.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Pegilodecakin (a lab-made immune protein called PEGylated interleukin-10)
What this could lead to
If it works, this could offer a new treatment option for people with advanced solid tumors that have stopped responding to standard therapies.
What could go wrong
This is an early, first-in-human trial focused on safety and dosing, so it is not yet known if pegilodecakin effectively shrinks tumors or improves survival. Side effects from the drug or chemotherapy combinations are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

353 people

The number who actually took part.

Started

Nov 2013

Finished

Jul 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Part A Escalation Cohorts: o Histologically or cytologically confirmed advanced malignant solid tumor, limited to melanoma, castrate resistant prostate cancer (CRPC), ovarian cancer (OVCA), renal cell carcinoma, colorectal carcinoma (CRC), pancreatic carcinoma or non-small cell lung carcinoma (NSCLC) that is refractory to, intolerant of, for which no standard of therapy is available or where the participant refuses existing therapies Part A Expansion Cohorts, Part B and C Escalation and Expansion Cohorts: * Tumors with all histological diagnosis or tissue origin may be enrolled * Participants must have failed prior standard curative chemotherapy for their disease, refuse existing therapies OR the proposed chemotherapy regimen to which pegilodecakin is added represents an acceptable standard treatment for their disease. * Measurable or evaluable disease according to irRC or bone metastatic disease evaluable by Prostate Cancer Working Group 2 criteria (PCWG2) for castration-resistant prostate cancer (CRPC) * At least 18 years of age * Performance Status of 0 or 1 * Adequate organ function Exclusion Criteria: * Hematologic malignancies * Pregnant or lactating * Present or history of neurological disorders such as Multiple Sclerosis and Guillain Barre or inflammatory central nervous system/peripheral nervous system (CNS/PNS) disorders * Myocardial infarction within the last 6 months * Unstable angina, or unstable cardiac arrhythmia requiring medication * Surgery within the last 28 days * Systemic fungal, bacterial, viral, or other infection * History of bleeding diathesis within the last 6 months * Positive for human immunodeficiency virus (HIV), hepatitis C, or hepatitis B

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm castration-resistant prostate carcinoma colorectal carcinoma colorectal neoplasm exocrine pancreatic carcinoma melanoma neoplasm non-small cell lung carcinoma ovarian cancer pancreatic adenocarcinoma pancreatic neoplasm prostate cancer renal cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer Colorectal carcinoma Melanoma Non-small cell lung carcinoma Ovarian cancer Pancreatic carcinoma Prostate cancer Renal cell carcinoma Solid tumors

Contacts and locations

Locations

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Florida Cancer Specialists & Research Institute

    Sarasota, Florida, 34232, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203, United States

  • Sarah Cannon Research Institute at HealthONE

    Denver, Colorado, 80218, United States

  • South Texas Accelerated Research Therapeutics

    San Antonio, Texas, 78229, United States

  • Stephenson Cancer Center at Oklahoma University TSET Phase 1 Program

    Oklahoma City, Oklahoma, 73104, United States

  • The University of Texas M.D. Anderson Cancer Center

    Houston, Texas, 77030, United States

  • UCLA Medical Hematology & Oncology

    Los Angeles, California, 90024, United States

  • UCSF

    San Francisco, California, United States

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