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, in Participants With Selected Advanced Solid Tumorsa
Cohort A2 (dose optimization), Cohorts B1 and B2 (dose expansion): Ovarian cancerc that is resistant to prior platinum treatment.d Individuals with platinum-refractory diseasee are not eligible
Cohort A3: Ovarian cancerc with high FRα expression (≥75% at ≥2+ intensity), no prior treatment with mirvetuximab soravtansine, and resistant to prior platinum treatment
Cohort A4 (combination cohort with bevacizumab): Ovarian cancerc sensitive to prior platinum treatment
Cohort A5 (dose escalation combination with carboplatin): Ovarian cancerc that is sensitive to prior platinum treatmentf
Cohorts C1 and C2 (dose expansion): 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
Any serious unresolved toxicities from prior therapy
History of pneumonitis/interstitial lung disease
Has significant cardiovascular disease
Has prolongation of the QTcF ≥470 ms
Has an active uncontrolled systemic bacterial, viral, fungal, or parasitic infection
Evidence of corneal keratopathy or history of corneal transplant
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.
c
Includes epithelial ovarian, primary peritoneal, and fallopian tube.
d
Recurrence or progression within 6 months of last platinum dose.
e
Progression on front-line platinum-based chemotherapy or within 3 months of completing front-line treatment.
f
Complete response (CR)/partial response (PR) or recurrence/progression-free interval of more than 6 months from last platinum dose.
For information on trial enrollment, locations, and more, call
1-800-545-5979.