Recruiting nowPhase 1
What this trial is trying to do
The researchers are testing LY4337713 in advanced solid tumours that have high levels of fibroblast activation protein (FAP), a protein found in the tumour environment. They will assess its safety, side effects, how the body processes it, and whether there are early signs of anti-cancer activity.
The idea is that selecting tumours with high FAP may identify cancers that LY4337713 can act on, but there is no comparison treatment in this trial. The main measure is dose-limiting toxicity—side effects that prevent increasing the dose—so the initial aim is to find a tolerable dose rather than show longer survival or delayed cancer growth.
Worth knowing: This non-randomised phase 1 trial is mainly testing safety and drug behaviour, and it is limited to tumours with high FAP; it cannot establish whether the treatment is better than standard care.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
| Registry number | NCT07213791 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 1 |
| Design | not randomised, open label |
| Taking part | 340 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | Eli Lilly and Company |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug LY4337713
What it is measuring
Phase 1a: Percentage of Participants with Dose Limited Toxicity (DLT) Toxicities
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
Phase 1. Tests safety and dose in a small group. Some people do benefit, but that is not what the trial is designed to find out.
How the researchers describe it
This is a study of LY4337713 in participants with certain types of cancer that is advanced or has spread. Participants must have cancer with high levels of a protein called fibroblast activation protein (FAP). The purpose of this study is to evaluate safety, side effects, and efficacy of LY4337713. In addition, this study will evaluate how much LY4337713 gets into the bloodstream, how it is broken down, and how long it takes the body to get rid of it. For each participant, the study will last about 5 years.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Metastatic
- Already treated
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
Inclusion Criteria
- Must have clinical or imaging evidence of fibroblast activation protein (FAP) expression per local assessment
- Must have histologically or cytologically confirmed diagnosis of one of the following:
- Adenocarcinoma of the pancreas
- Hormone receptor (HR)-positive human epidermal growth factor 2 (HER2)-negative breast cancer
- HER2-positive breast cancer
- Triple negative breast cancer (TNBC)
- Platinum-resistant or refractory ovarian cancer (including ovarian carcinosarcoma)
- Gastric cancer (adenocarcinoma)
- Colorectal cancer (CRC)
- Esophageal cancer (squamous cell carcinoma or adenocarcinoma)
- Cholangiocarcinoma
- Other non- central nervous system (CNS) solid tumors, which have demonstrated FAP uptake via positron emission tomography (PET),
- Must have received prior treatments as indicated below:
- Phase 1a
- Adenocarcinoma of the pancreas: Participants must have received at least 1, but no more than 2 prior regimens for locally advanced unresectable or metastatic disease.
- HR-positive HER2-negative breast cancer: Participants must have received less than or equal to (≤)5 prior lines of treatment for advanced or metastatic disease, which must include a cyclin-dependent kinase 4/6 inhibitor.
- HER2-positive breast cancer: Participants must have received at least 2 lines of HER2-targeted therapy, which should include at least 1 a…
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 30 sites. Listed in: China, Germany, Japan, Netherlands, United States.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT07213791, registered by Eli Lilly and Company on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.