Trials / Active Not Recruiting
Active Not RecruitingNCT05266105
A Phase 1 Study of Oral OP-1250 in Combination With Palbociclib in HR+/HER2- Breast Cancer Patients
A Phase 1 Dose Escalation and Expansion Open-label, Multicenter, Study of OP-1250 in Combination With the CDK4/6 Inhibitor Palbociclib in Adult Subjects With Advanced or Metastatic HR-positive, HER2-negative Breast Cancer
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Olema Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is an open-label, Phase 1b dose escalation and expansion study to determine the maximum tolerated dose (MTD) of OP-1250 in combination with palbociclib (Ibrance®️, Pfizer Inc.). Purpose of study is to evaluate the safety and pharmacokinetic (PK) profile, and estimate the preliminary anti-tumor activity of the combination in adult subjects with hormone receptor-positive (ER+ / HER2-) advanced or metastatic breast cancer (MBC).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Palazestrant | Complete Estrogen Receptor Antagonist |
| DRUG | Palbociclib | Palbociclib is an approved CDK 4/6 Inhibitor drug |
Timeline
- Start date
- 2021-12-10
- Primary completion
- 2026-03-01
- Completion
- 2026-03-01
- First posted
- 2022-03-04
- Last updated
- 2025-11-24
Locations
8 sites across 1 country: Australia
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05266105. Inclusion in this directory is not an endorsement.