A Study of LY4337713 in Participants With FAP-Positive Solid Tumors

Korábbi kezelés

• 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.)

Más betegség

• Have significant cardiovascular disease

Laborértékek

• Have prolongation of the corrected QTcF >470 milliseconds (msec) during screening. QTcF is calculated using Fridericia's Formula: QTcF = QT/(RR0.33)

Egyéb

• Have known active central nervous system (CNS) metastases or carcinomatous meningitis.
• Have evidence of ongoing and untreated urinary tract obstruction
• 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).

• 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)
  • Gastric cancer (adenocarcinoma)
  • Colorectal cancer (CRC)
  • Esophageal cancer (squamous cell carcinoma or adenocarcinoma)
  • Cholangiocarcinoma
  • Other non- central nervous system (CNS) solid tumors, which have demonstrated FAP uptake via positron emission tomography (PET),
• 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 1 prior line of therapy for metastatic disease, and must have received an ADC unless unavailable, ineligible, or refused.
  • Platinum-resistant or refractory ovarian cancer: Participants must have received or after at least 1 platinum-based therapy.
  • Gastric cancer, CRC, esophageal cancer (squamous cell carcinoma or adenocarcinoma), and cholangiocarcinoma: Participants must have received greater than or equal to (≥)1 prior line of systemic therapy for advanced or metastatic disease; this may include, but does not require, prior line(s) in combination with immunotherapy or vascular endothelial growth factor inhibitor.
  • Other non-CNS solid tumors: Participants must have exhausted, be ineligible for, or refused all standard-of-care therapy appropriate for their disease.
  • 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)