Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Palazestrant | Drug | — | UNRESOLVED |
| Palbociclib | Drug | Palbociclib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Dose Escalation
- description
- This portion of the study will evaluate the safety and pharmacology of a range of OP-1250 doses administered daily with Palbociclib in subjects with advanced and/or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer
- interventionNames
- Drug: Palazestrant
- Drug: Palbociclib
- type
- EXPERIMENTAL
- label
- Dose Expansion
- description
- This portion of the study further explores the clinical activity, safety and pharmacology of OP-1250 in combination with Palbociclib and estimates preliminary data of anti-tumor efficacy
- interventionNames
- Drug: Palazestrant
- Drug: Palbociclib
Primary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Confirmed and evaluable locally advanced or metastatic breast cancer * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Must not have received prior oral endocrine or targeted therapy ≤ 2 weeks prior to first dose * Must not have received prior chemotherapy, antibody therapy, or investigational therapy ≤ 4 weeks prior to the first dose * Prior radiotherapy must have been completed 2 weeks prior to first dose * Adequate safety laboratory tests * Willingness to use effective contraception Exclusion Criteria: * Gastrointestinal disease * Significant hepatic disease * Significant cardiovascular disease * Significant ECG abnormalities * History of pulmonary embolism or high risk of thrombosis * Known HIV infection * Active infection (requiring antimicrobial therapy) * Pregnant
References
Publications (0)
Data not yet available