Trial NCT07213791
A Study of LY4337713 in Participants With FAP-Positive Solid Tumors
- Phase
- Phase 1
- Sponsor
- Eli Lilly and Company
- Conditions
- Ovarian Neoplasms; Breast Neoplasms; Pancreatic Intraductal Neoplasms; Colorectal Neoplasms; Esophageal Neoplasms; Stomach Neoplasms; Cholangiocarcinoma
- Ages
- 18+ years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
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.Performance status
* Measured creatinine clearance ≥60 milliliters per minute (mL/min)Renal
Exclusion Criteria:
* Have known active central nervous system (CNS) metastases or carcinomatous meningitis.Brain metastases
* Have significant cardiovascular disease
* Have prolongation of the corrected QTcF >470 milliseconds (msec) during screening.Cardiac 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).
Restrictions found (4)
- Brain metastasesOutrightexclusionShow in the text
- CardiacOutrightexclusion
QTcF >470 msec
Show in the text - Performance statusOutrightinclusion
ECOG PS 0 to 1
Show in the text - RenalOutrightinclusion
CrCl ≥60 mL/min
Show in the text
Recruiting in Massachusetts
- Massachusetts General Hospital · Boston, Suffolk County