NSCLC SCLC Endometrial Neoplasms Neoplasm Metastasis TNBC
Conditions
Interventions
DRUG: LY4175408
IV infusion
[Study Arms]
Experimental: Phase 1a Dose Escalation (Cohort A1)
Escalating doses of LY4175408 administered intravenously (IV)
Interventions:
Drug: LY4175408
Expe
Sponsors
Masaki Takeshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Have one of the following advanced or metastatic solid tumor cancers: * Non-small cell lung cancer (NSCLC) * Small cell lung cancer (SCLC) * Endometrial cancer * Triple negative breast cancer (TNBC) (characterized by HR-negative disease and HER2-negative expression according to American Society of Clinical Oncology (ASCO) - College of American Pathologists guidelines). - Received all standard therapies for which the individual was deemed to be an appropriate candidate by the treating investigator; OR the individual is refusing the remaining most appropriate standard of care treatment; OR there is no standard therapy available for the disease. - Eastern Cooperative Oncology Group (ECOG) performance status of <=1. - For dose optimization/dose and expansion cohorts (Cohort A2, Cohort B): Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Exclusion criteria
Exclusion criteria: - Prior treatment with a protein tyrosine kinase 7 (PTK7) antibody-drug conjugate (ADC) with a topoisomerase I inhibitor as payload (prior therapy with a PTK7 ADC with a non-topoisomerase I inhibitor payload OR non-PTK7 ADC with any payload is permitted). - Any serious unresolved toxicities from prior therapy. - Individual with known or suspected history of uncontrolled central nervous system (CNS) metastases. - Individual with active uncontrolled systemic bacterial, viral, fungal, or parasitic infection. - 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 the trial or within 30 days of the last dose of trial intervention.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase 1a-Number of Participants with Dose Limiting Toxicities of LY4175408 [ Time Frame: 1 Cycle (21 days) Phase 1b-Overall Response Rate (ORR): Percentage of Participants with Best Response of Complete Response (CR) or Partial Response (PR) [ Time Frame: Baseline up to approximately 4 years] | — |
Countries
France, Japan, Republic of Korea, Spain, United States
Contacts
Public ContactTrial Guide Call Center Trial Guide Call Center
Eli Lilly Japan K.K.
Outcome results
None listed