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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
* 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 prior line(s) in combination with immunotherapy or vascular endothelial growth factor inhibitor.
* 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)
Exclusion Criteria:
* 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).
Primary outcome measure(s)
Phase 1a: Percentage of Participants with Dose Limited Toxicity (DLT) Toxicities — Cycle 1 (28 days)
Phase 1b: Objective Response Rate (ORR): Percentage of Participants with Best Response of Complete Response (CR) or Partial Response (PR) — Baseline through imaging follow-up, up to 5 years Per investigator assessed Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
Trial sites (30)
Facility
City
Region
Status
Hoag Memorial Hospital Presbyterian
Newport Beach
California
Recruiting
Stanford University Medical Center
Stanford
California
Recruiting
Biogenix Molecular, LLC
Miami
Florida
Completed
Moffitt
Tampa
Florida
Recruiting
Indiana University (IU) School of Medicine
Indianapolis
Indiana
Recruiting
United Theranostics
Glen Burnie
Maryland
Recruiting
Massachusetts General Hospital
Boston
Massachusetts
Recruiting
Beth Israel Deaconess Medical Center
Boston
Massachusetts
Not Yet Recruiting
Barbara Ann Karmanos Cancer Institute
Detroit
Michigan
Recruiting
BAMF Health Inc.
Grand Rapids
Michigan
Recruiting
Mayo Clinic - Rochester
Rochester
Minnesota
Not Yet Recruiting
Washington University School of Medicine in St. Louis
St Louis
Missouri
Recruiting
New York University (NYU) Clinical Cancer Center
New York
New York
Recruiting
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
New York
New York
Recruiting
Duke University Medical Center
Durham
North Carolina
Recruiting
University of Pennsylvania
Philadelphia
Pennsylvania
Recruiting
Fox Chase Cancer Center
Philadelphia
Pennsylvania
Recruiting
Texas Oncology - DFW (Sammons CC)
Dallas
Texas
Recruiting
Baylor College of Medicine
Houston
Texas
Not Yet Recruiting
University of Wisconsin - Carbone Cancer Center
Madison
Wisconsin
Recruiting
Fudan University Zhongshan Hospital
Shanghai
China
Not Yet Recruiting
Universitaetsklinikum Essen
Essen
Germany
Not Yet Recruiting
National Cancer Center Hospital East
Chiba
Japan
Not Yet Recruiting
Kyoto University Hospital
Kyoto
Japan
Not Yet Recruiting
Nederlands Kanker Instituut - Antoni van Leeuwenhoek Ziekenhuis (NKI-AVL)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.