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New treatment option for Ovarian Neoplasms
Official title A Study of LY4337713 in Participants With FAP-Positive Solid Tumors
ClinicalTrials.gov ID: NCT07213791
What this study is testing
What is LY4337713?
LY4337713 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for ovarian neoplasms.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- Have known active central nervous system (CNS) metastases or carcinomatous meningitis.
- Have significant cardiovascular disease
- Have prolongation of the corrected QTcF \>470 milliseconds (msec) during screening. QTcF is calculated using Fridericia's Formula: QTcF = QT/(RR0.33)
- Have evidence of ongoing and untreated urinary tract obstruction
- Had previous hemi- or total-body radiation.
- Had previous adoptive T-cell therapy (e.g., chimeric antigen receptor T-cell [CAR-T therapy, T-cell receptor [TCR] therapy, etc.)
See the full eligibility 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.
- Platinum-resistant or refractory ovarian cancer: Participants must have received or after at least 1 platinum-based therapy.
- Other solid tumors (gastric cancer, CRC, esophageal and cholangiocarcinoma): Participants must have received greater than or equal to (≥)1 prior line of systemic therapy for advanced or metastatic disease; including...
- Phase 1b:
- Participants must have advanced or metastatic solid tumors and have received ≥1 prior line of therapy.
- Must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1.
- Measured creatinine clearance ≥60 milliliters per minute (mL/min)
- Have known active central nervous system (CNS) metastases or carcinomatous meningitis.
- Have significant cardiovascular disease
- Have prolongation of the corrected QTcF \>470 milliseconds (msec) during screening. QTcF is calculated using Fridericia's Formula: QTcF = QT/(RR0.33)
- Have evidence of ongoing and untreated urinary tract obstruction
- Had previous hemi- or total-body radiation.
- Had previous adoptive T-cell therapy (e.g., chimeric antigen receptor T-cell [CAR-T therapy, T-cell receptor [TCR] therapy, etc.)
- Unable to lie flat during, or otherwise tolerate, single photon emission computed tomography (SPECT), positron emission tomography (PET), computed tomography (CT) or magnetic resonance imaging (MRI).
The study team makes the final eligibility decision.
Where it's taking place
- Newport Beach, California, United States
- Stanford, California, United States
- Miami, Florida, United States
- Tampa, Florida, United States
- Indianapolis, Indiana, United States
- Glen Burnie, Maryland, United States
- Boston, Massachusetts, United States
- Detroit, Michigan, United States
- Grand Rapids, Michigan, United States
- Rochester, Minnesota, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Philadelphia, Pennsylvania, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Madison, Wisconsin, United States
- Shanghai, China
- Essen, Germany
- Chiba, Japan
+ 6 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Newport Beach, California, United States; Stanford, California, United States; Miami, Florida, United States; Tampa, Florida, United States; Indianapolis, Indiana, United States; Glen Burnie, Maryland, United States and 20 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.