U3-1402 in Metastatic or Unresectable Non-Small Cell Lung Cancer
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Phase
Phase 1
Status
Active, not recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
312actual
Sites
37
Countries
Japan, Netherlands, South Korea +3
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2017-10-30 | actual | When the study began enrolling |
| Primary completion | 2026-03-31 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-12-31 | estimated | The whole study's end, after follow-up |
| First posted | 2017-08-24 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-03-05 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Non-Small Cell Lung Cancer (NSCLC)
Interventions
- Drug: HER3-DXd (FL-DP) — also filed as U3-1402
- Drug: HER3-DXd (CTM-1 Lyo-DP) — also filed as U3-1402
- Drug: HER3-DXd (CTM-3 Lyo-DP) — also filed as U3-1402
Primary outcomes
what the primary-completion date above is the date OFDose-limiting toxicities (DLTs) during dose escalation
measured 21 days of Cycle 1
Summary of adverse events during dose escalation
measured By the global end of trial date, approximately within 36 months
Overall response rate (ORR) assessed by Blinded Independent Central Review (BICR) Committee during dose expansion (Dose Expansion Cohorts 1, 2, 3a, 3b, and Cohort 5)
measured Approximately within 36 months
Maximum serum concentration (Cmax) of HER3-DXd, total anti-HER3 antibody, and MAAA-1181a during dose expansion (Cohort 4)
measured During the first 5 cycles (each cycle is 21 days), including an intensive sampling schedule: pre-dose, end of infusion (EOI), 2 hour (hr), 4 hr, 8 hr post infusion, Day 8, and Day 15.
Area under the serum concentration-time curve from time 0 extrapolated to infinity (AUCinf) and up to last quantifiable time (AUC[last]) of HER3-DXd, total anti-HER3 antibody, and MAAA-1181a during dose expansion (Cohort 4)
measured During the first 5 cycles (each cycle is 21 days), including an intensive sampling schedule: pre-dose, end of infusion (EOI), 2 hour (hr), 4 hr, 8 hr post infusion, Day 8, and Day 15.
Publications
- PMID 19949011 — cited as background
- PMID 40554742 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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