Recruiting nowPhase 1
What this trial is trying to do
The researchers are testing LY4257496, alone or combined with standard cancer treatment, in advanced cancers whose cells have the gastrin-releasing peptide receptor (GRPR). A companion imaging or diagnostic test, LY4257529, is intended to identify tumours with high GRPR levels and help determine who has the target.
The idea is that selecting cancers with GRPR may identify people most likely to benefit from LY4257496, either on its own or alongside usual treatment. At this stage, the main question is how much LY4257496 can be given safely; the trial will also look for signs of tumour control, but it has no randomised comparison with standard treatment.
Worth knowing: This is a non-randomised phase 1 study, so its primary purpose is safety and dose-finding rather than showing that the treatment improves survival or delays cancer growth.
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 | NCT07114601 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 1 |
| Design | not randomised, open label |
| Taking part | 421 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 LY4257496
- Drug Standard of Care Anticancer Therapies
- Test LY4257529
What it is measuring
Phase 1a Dose Escalation: Maximum Tolerated Dose of LY4257496
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
The main purpose of this study is to evaluate safety, tolerability, and efficacy of LY4257496 alone and as part of relevant standard of care (SOC) combination therapy in participants with Gastrin-releasing Peptide Receptor (GRPR)-positive advanced cancer, including but not limited to breast, colorectal, prostate, endometrial, esophageal, gastroesophageal (GE) junction, and gastric cancer. The study will also evaluate the safety, tolerability, and efficacy of LY4257529 to identify cancer with high levels of a protein called GRPR. This is a 2-part study. Participation could last up to 36 weeks or until your tumor progresses.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- HER2 positive
- Metastatic
- Locally advanced
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 histologically or cytologically proven diagnosis of locally advanced, unresectable, or metastatic cancer.
- Must be assessed by computed tomography (CT)/magnetic resonance imaging (MRI) to confirm at least 1 of the following:
- At least 1 measurable target lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- If only bone lesions are present without a soft-tissue component, a bone scan or MRI must confirm at least 2 detectable lesions considered to represent active metastases
- Must have GRPR-positive disease, defined by investigator assessment of GRPR imaging.
- Must have the following histologically or cytologically confirmed diagnosis:
- Estrogen receptor (ER+)/human epidermal growth factor receptor 2 (HER2-) breast cancer
- ER+/HER2+ breast cancer
- Esophageal squamous cell carcinoma
- Adenocarcinoma of the stomach, gastroesophageal junction, or esophagus
- Colorectal carcinoma
- Metastatic castration-resistant prostate cancer
- Endometrial carcinoma. Carcinosarcoma is eligible.
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 33 sites. Listed in: Canada, China, France, Germany, Japan, Spain, 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 NCT07114601, 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.