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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts 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 - 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 progressed after 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 progressed on 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 progressed on at least 2 lines of therapy for metastatic disease. - Platinum-resistant or refractory ovarian cancer: Participants must have progressed on 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 history of Grade 4 myelosuppression lasting greater than (>)7 days, or Grade 3 myelosuppression requiring more than 6 weeks recovery. - 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).

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
LY4337713 (Cohort A1) 		Escalating doses of LY4337713 administered intravenously (IV).
  • Drug: LY4337713
    Administered IV.
Experimental
LY4337713 (Cohort A2) 		Two or more dose regimens of LY4337713 (evaluated during dose escalation) administered IV.
  • Drug: LY4337713
    Administered IV.
Experimental
Experimental: LY4337713 (Cohort B) 		Tumor specific cohort will receive LY4337713 administered IV.
  • Drug: LY4337713
    Administered IV.
Experimental
Experimental LY4337713 (Cohort C) 		Tumor specific cohort will receive LY4337713 administered IV.
  • Drug: LY4337713
    Administered IV.
Experimental
Experimental: LY4337713 (Cohort D) 		Tumor specific cohort will receive LY4337713 administered IV.
  • Drug: LY4337713
    Administered IV.
Experimental
LY4337713 (Cohort E) 		Tumor specific cohort will receive LY4337713 administered IV.
  • Drug: LY4337713
    Administered IV.

Recruiting Locations

Hoag Memorial Hospital Presbyterian
Newport Beach 5376890, California 5332921 92663

Biogenix Molecular, LLC
Miami 4164138, Florida 4155751 33165

More Details

Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
LillyTrials@Lilly.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.