A Study of LY4337713 in Participants With FAP-Positive Solid Tumors (NCT07213791) | Clinical Trial Compass
RecruitingPhase 1
A Study of LY4337713 in Participants With FAP-Positive Solid Tumors
United States, China, Germany241 participantsStarted 2025-10-22
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
* Other solid tumors
* Gastric cancer (adenocarcinoma)
* Colorectal cancer (CRC)
* Esophageal cancer (squamous cell carcinoma or adenocarcinoma)
* Cholangiocarcinoma
* 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 antibody-drug conjugate (ADC) for metastatic disease (if locally available).
* TNBC: Participants must have received at least 2 lines of therapy for metastatic disease.
* Platin…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Phase 1a: Percentage of Participants with Dose Limited Toxicity (DLT) Toxicities
Timeframe: Cycle 1 (28 days)
2
Phase 1b: Objective Response Rate (ORR): Percentage of Participants with Best Response of Complete Response (CR) or Partial Response (PR)
Timeframe: Baseline through imaging follow-up, up to 5 years
Trial details
NCT IDNCT07213791
SponsorEli Lilly and Company
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2028-07
Contact for this trial
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or