A Phase 1 Study of Oral OP-1250 in Combination With Palbociclib in HR+/HER2- Breast Cancer Patients
← catalyst calendarSponsored by Olema Pharmaceuticals, Inc. (industry) · OLMA — their whole pipeline →. With Pfizer.
Phase
Phase 1
Status
Active, not recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
60actual
Sites
8
Country
Australia
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 | 2021-12-10 | actual | When the study began enrolling |
| Primary completion | Mar 2026 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Mar 2026 | estimated | The whole study's end, after follow-up |
| First posted | 2022-03-04 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-11-24 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Breast Cancer
Interventions
- Drug: Palazestrant — also filed as OP-1250
- Drug: Palbociclib — also filed as Ibrance®️
Primary outcomes
what the primary-completion date above is the date OFIncidence of Dose Limiting Toxicities
measured From Cycle 1 Day 1 through C1 Day 28
Characterization and Incidence in Adverse Events and Serious Adverse Events
measured From initial inform consent date through 30 days post last dose
Plasma levels of OP-1250 and Palbociclib
measured Up to 9 months
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