Study of Narazaciclib (ON 123300) Plus Letrozole in Endometrial Cancer and Other Gynecologic Malignancies
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Phase
Phase 1/2
Status
Unknown status
Study type
Interventional
Design
Na · None · Treatment
Enrollment
60estimated
Sites
8
Country
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 | 2023-03-29 | actual | When the study began enrolling |
| Primary completion | Jan 2026 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Feb 2026 | estimated | The whole study's end, after follow-up |
| First posted | 2023-01-30 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2023-12-12 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Endometrioid Endometrial Cancer
Interventions
- Drug: Narazaciclib — also filed as ON 123300, HX-301
- Drug: Letrozole 2.5mg — also filed as Femara
Primary outcomes
what the primary-completion date above is the date OFDose limiting toxicities (DLTs) will be tabulated and summarized by cohort
measured From First dose until end of Cycle 1 (28 days)
Treatment-emergent adverse events (TEAEs), including DLTs will be graded by CTCAE v5.0
measured From first dose until 30 days after final dose, up to approximately 1 year
Phase 2 - Progression-free survival (PFS) at 24 weeks by Investigator assessment
measured Measured from first dose until 24-weeks
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