A Dose-escalation Study of LUNA18 in Patients With Locally Advanced or Metastatic Solid Tumors (With Expansion).
← catalyst calendarSponsored by Chugai Pharmaceutical (industry) · 4519.T — their whole pipeline →.
Phase
Phase 1
Status
Terminated
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
128actual
Sites
20
Countries
Japan, United States
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
Why the sponsor stopped it
Sponsor decided to discontinue this study upon having LPLV.
As filed on the registry record, in the sponsor's own words.
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2021-10-08 | actual | When the study began enrolling |
| Primary completion | 2025-11-13 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-11-13 | actual | The whole study's end, after follow-up |
| First posted | 2021-08-19 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-12-24 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Locally Advanced or Metastatic Solid Tumors
Interventions
- Drug: LUNA18
- Drug: Cetuximab
Primary outcomes
what the primary-completion date above is the date OFSafety and tolerability of LUNA18 (Dose-limiting toxicities) when administered as a single agent [Part A] and in combination with other anti-cancer drugs [Part D]
measured From Cycle 0 Day 1 until Cycle 1 Day 28 (Cycle 0 is 6-9 days, and Cycle 1 is 28 days)
Safety and tolerability of LUNA18 (Adverse Events) [Part A, AA, B, C, D and E]
measured From Cycle 0 Day 1 (Cycle 0 is 6-9 days) until study completion or treatment discontinuation (up to approximately 43 months)
Plasma concentrations of LUNA18 when administered as a single agent [Part A, AA] and in combination with other anti-cancer drugs [Part D]
measured From Cycle 0 Day 1 (Cycle 0 is 6-9 days) until study completion or treatment discontinuation (up to approximately 43 months)
Maximum plasma concentration (Cmax) of LUNA18 when administered as a single agent [Part A, AA] and in combination with other anti-cancer drugs [Part D]
measured From Cycle 0 Day 1 (Cycle 0 is 6-9 days) until study completion or treatment discontinuation (up to approximately 43 months)
Time to reach maximum plasma drug concentration (Tmax) of LUNA18 when administered as a single agent [Part A, AA] and in combination with other anti-cancer drugs [Part D]
measured From Cycle 0 Day 1 (Cycle 0 is 6-9 days) until study completion or treatment discontinuation (up to approximately 43 months)
Area under the concentration versus time curve (AUC) of LUNA18 when administered as a single agent [Part A, AA] and in combination with other anti-cancer drugs [Part D]
measured From Cycle 0 Day 1 (Cycle 0 is 6-9 days) until study completion or treatment discontinuation (up to approximately 43 months)
Phosphorylation level of ERK protein (pERK) in tumor tissues [Part B]
measured From screening until the time of clinical responses and/or the time of progressive disease (up to approximately 43 months), if feasible
Preliminary anti-tumor activity of LUNA18 when administered as a single agent [Part B, C] and in combination with other anti-cancer drugs [Part E]
measured From screening until disease progression, study discontinuation, withdrawal or death, whichever occurs first (up to approximately 43 months)
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