A Dose-Escalation Study of SPYK04 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
Completed
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
85actual
Sites
15
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
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2020-09-10 | actual | When the study began enrolling |
| Primary completion | 2026-06-18 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-06-18 | actual | The whole study's end, after follow-up |
| First posted | 2020-08-13 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-30 | 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
Intervention
- Drug: SPYK04
Primary outcomes
what the primary-completion date above is the date OFSafety and tolerability of SPYK04 (Dose limiting toxicities) [Dose escalation]
measured From first dose until the end of Cycle 1 (approximately 35 days)
Safety and tolerability of SPYK04 (Adverse Events) [Dose escalation]
measured From Cycle 0 Day 1 until 28 days after the last dose of study treatment, assessed up to 42 months (study completion)
Safety and tolerability of SPYK04 (Electrocardiograms in triplicate) [Dose escalation]
measured From first dose until the end of Cycle 1 (approximately 35 days)
Safety and tolerability of SPYK04 (Electrocardiograms in triplicate) [Dose escalation]
measured From first dose until the end of Cycle 1 (approximately 35 days)
Pharmacokinetics of SPYK04 [Dose escalation]
measured From Cycle 0 Day 1 until 28 days after the last dose of study treatment, assessed up to 42 months (study completion)
Pharmacokinetics of SPYK04 [Dose escalation]
measured From Cycle 0 Day 1 until 28 days after the last dose of study treatment, assessed up to 42 months (study completion)
Pharmacokinetics of SPYK04 [Dose escalation]
measured From Cycle 0 Day 1 until 28 days after the last dose of study treatment, assessed up to 42 months (study completion)
Pharmacokinetics of SPYK04 [Dose escalation]
measured From Cycle 0 Day 1 until 28 days after the last dose of study treatment, assessed up to 42 months (study completion)
Preliminary anti-tumor activity of SPYK04 [Cohort expansion]
measured From screening until disease progression, study discontinuation, withdrawal or death, whichever occurs first, assessed up to 42 months (study completion)
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