Skip to content
DataLookout
Start free
Menu

NCT07046923

A Study of LY4175408 in Participants With Advanced Cancer

StatusActive, Not Recruiting
PhasePhase 1
Primary completion (estimated)
Track this trial

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Record History

All 18 versions: 18 with changes below. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 17 words
    • Enrollment closed, study ongoing
    • Trial sites reduced: 27 → 24 locations
  2. Study sites revised (27)v17
  3. Eligibility criteria expanded, about 67 words
    • Trial arms changed: 3 → 5
    • Study sites: 25 to 27
    • Interventions: LY4175408 (Drug) to Carboplatin (Drug), Cisplatin (Drug), LY4175408 (Drug), Pembrolizumab (Drug)
    v16
  4. Study sites: 24 to 25v15
  5. Site details revised at 1 of 24 sitesv14
Show 12 earlier versionsHide 12 earlier versions
  1. Site details revised at 1 of 24 sitesv13
  2. Site details revised at 3 of 24 sitesv12
  3. Site details revised at 4 of 24 sitesv11
  4. Site details revised at 3 of 24 sitesv10
  5. Site details revised at 1 of 24 sitesv9
  6. Site details revised at 2 of 24 sitesv8
  7. Study Status, Referencesv7
  8. Site details revised at 1 of 24 sitesv6
  9. Site details revised at 1 of 24 sitesv5
  10. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 23 to 24
    • Start date changed from estimate of Jul 2025 to Jul 28, 2025
    v4
  11. Eligibility criteria revisedv3
  12. Study sites: 21 to 23v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Phase 1a-Number of Participants with Dose Limiting Toxicities of LY4175408
Timeframe: 1 Cycle (21 days)
Phase 1b-Overall Response Rate (ORR): Percentage of Participants with Best Response of Complete Response (CR) or Partial Response (PR)
Timeframe: Baseline up to approximately 4 years

Secondary (7)

Phase 1a and 1b-Pharmacokinetics (PK): Minimum Plasma Concentration (Cmin) of LY4175408 (total antibody, conjugated antibody, free payload)
Phase 1a and 1b-PK: Area under the Concentration versus Time Curve (AUC) of LY4175408 (total antibody, conjugated antibody, free payload)
Phase 1a-ORR: Percentage of Participants with Best Response of CR or PR
Phase 1a and 1b-Time to Response (TTR)
Phase 1a and 1b-Progression-free Survival (PFS)
Show 2 moreShow less
Phase 1a and 1b-Disease Control Rate (DCR)
Phase 1a and 1b-Duration of Response (DOR)

Arms and interventions

Phase 1a Dose Escalation (Cohort A1)Experimental

Escalating doses of LY4175408 administered intravenously (IV)

Phase 1a Dose Optimization (Cohort A2)Experimental

Two or more doses of LY4175408 (evaluated during dose escalation) administered IV

Phase 1b Dose Expansion (Cohort B1)Experimental

LY4175408 administered IV followed by pembrolizumab administered IV

Phase 1b Dose Expansion (Cohort B2)Experimental

LY4175408 administered IV followed by pembrolizumab administered IV and either carboplatin administered IV or cisplatin administered IV

Phase 1b Dose Expansion (Cohorts C1, C2 and C3)Experimental

LY4175408 administered IV

Drugs: LY4175408, Pembrolizumab, Carboplatin, Cisplatin

Sites

24 sites in 5 countries

United States 15, Japan 3, France 2, South Korea 2, Spain 2