Phase 2 study

Recruiting Phase 2

Sources: ClinicalTrials.gov Checked: 11 October 2026 Not medical advice

This trial at a glance

Status Recruiting
Phase Phase 2
Sponsor Eli Lilly and Company
Registry number NCT05999994
Started 22 January 2020 Today 16 October 2026 Estimated completion 1 May 2027

Where this trial is running

Trial sites and the status recorded for each
SiteCityState or countryStatus at this site
Chris O'Brien Lifehouse Camperdown NSW Completed
Peter MacCallum Cancer Centre Melbourne VIC Completed
Royal Children's Hospital Melbourne VIC Completed

voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice

Who can join

Age 1 Year to 39 Years
Sex Anyone, regardless of sex
Healthy volunteers Not accepted
Enrolment target 105

The official eligibility criteria

Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.

Inclusion Criteria:

Participants must meet all of the inclusion criteria below. Additional criteria are specified in the protocol amendment (individual addenda) to which the participant will enroll.

* Have either measurable or evaluable disease using standard techniques by the Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1).

* The participant has a Lansky (\<16 years of age) or Karnofsky (≥16 years of age) performance score of at least 50.

* Participants must have discontinued all previous treatments for cancer or investigational agents greater than or equal to (≥)7 days after the last dose and must have recovered from clinically significant side effects.

* The participant has adequate hematologic and organ function.

* Female participants of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to first dose.

* Both female and male participants of childbearing potential must agree to use highly effective contraceptive precautions during the trial and for at least 3 months following the last dose of study drug.

Participants will be ineligible if they meet any of the exclusion criteria below. Additional criteria are specified in the protocol amendment to which the participant will enroll.

* Participants with severe and/or uncontrolled concurrent medical disease or psychiatric illness/social situation that, in the opinion of the investigator, could cause unacceptable safety risks or compromise compliance with the protocol.

* Participants who have active infections requiring therapy.

* Participants who have had allogeneic bone marrow or solid organ transplant.

* Participants who have had, or are planning to have, certain invasive procedures.

* Female participants who are pregnant or breastfeeding.

Dates on the record

Started 22 January 2020
Estimated completion 1 May 2027
Registry last updated 7 August 2026
Checked by Voxsanity 11 October 2026

Results, publications and the official record

Sources and dates

  • ClinicalTrials.gov – the record this page reformats
  • ClinicalTrials.gov processing date: 7 August 2026.
  • This page last checked by Voxsanity: 11 October 2026.

Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.

Not medical advice.

Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.

Letter for your doctor

A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.