A First-in-Human, Phase 1a/1b Trial to Assess the Safety, Tolerability and Preliminary Efficacy of LY4170156, an Antibody-Drug Conjugate Targeting Folate Receptor α-Expressing Tumor Cells, in Participants With Selected Advanced Solid Tumorsa
Participants aged ≥18 years with historic diagnosis of locally advanced or metastatic solid tumor malignancy as defined below for each cohort:
Cohort A1 (dose escalation): Histological diagnosis of ovarian cancer (includes epithelial ovarian, primary peritoneal, and fallopian tube), endometrial cancer, cervical cancer, non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC), pancreatic cancer, or colorectal cancer (CRC)
Cohort A2 (dose optimization), Cohorts B1 and B2 (dose expansion): Histological diagnosis of ovarian cancer (includes epithelial ovarian, primary peritoneal, and fallopian tube) that is resistant to prior platinum treatment (defined as recurrence or progression within 6 months of last platinum dose). Individuals with platinum-refractory disease (progression on front-line platinum-based chemotherapy or within 3 months of completing front-line treatment) are not eligible
Cohorts C1 and C2 (dose expansion): Histological or cytological diagnosis of endometrial cancer, cervical cancer, NSCLC, TNBC, pancreatic cancer, or CRC
Key Exclusion Criteria
Known or suspected uncontrolled central nervous system (CNS) metastases
History of carcinomatous meningitis
Active uncontrolled systemic bacterial, viral, fungal, or parasitic infection
Evidence of corneal keratopathy or history of corneal transplant
Any serious unresolved toxicities from prior therapy
Significant cardiovascular disease
Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) >470 milliseconds (ms)
History of pneumonitis/interstitial lung disease
Individuals who are pregnant, breastfeeding, or plan to breastfeed during study or within 30 days of last dose of study intervention
a
This clinical trial is being conducted globally.
b
Administered intravenously.
For information on trial enrollment, locations, and more, call
1-800-545-5979.